THE FACTS ABOUT PRESCRIPTION DRUGS

LINK BETWEEN ANTIDEPRESSANTS AND AUTISM

2011-07-18T12:26:00.000-07:00

In the first study of its kind, researchers have discovered a link between SSRI (selective serotonin reuptake inhibitor) antidepressants and autism. If a pregnant mother uses an antidepressant drug such as Paxil, Zoloft, Celexa, Lexapro, or Prozac, especially during the first trimester, the child is more likely to develop an autism spectrum disorder.

SSRI antidepressants are prescribed to treat depression and anxiety in adults, by increasing levels of serotonin in the brain. Evidence suggests that the use of an SSRI antidepressant during pregnancy may affect the unborn child’s development and ability to process and maintain proper levels of serotonin in the brain. Children with an autism spectrum disorder often have difficulty regulating and maintaining levels of serotonin in the brain. The following drugs have been linked to autism spectrum disorder:

PAXIL

PROZAC

ZOLOFT

CELEXA

LEXAPRO

The study, released in July 2011, found that after taking other autism risk factors into account, children who were exposed to SSRI antidepressants in utero were twice as likely to develop an autism spectrum disorder, and children who were exposed to SSRI antidepressants during the first trimester were four times as likely to develop an autism spectrum disorder.

Autism spectrum disorders affect 1 in 110 children in the US and 1 in 70 boys. It is the fastest growing serious developmental disease in the United States, and there is no cure. Autism spectrum disorders (ASD) include the following disorders:

Autism: a neural development disorder marked by impaired social interaction, impaired communication, restricted interests, and repetitive behavior.

Asperger syndrome: Most similar to classic autism, except without the delay in language development.

Pervasive Developments Disorder Not Otherwise Specified (PDD-NOS): a developmental disorder that does not meet the criteria for autism or Asperger’s syndrome.

Rett Syndrome & Childhood Disintegrative Disorder: Other developmental disorders that sometimes fall within the autism spectrum.

If your child has been diagnosed with an autism spectrum disorder and was exposed to an SSRI antidepressant during pregnancy, you and your child may be entitled to compensation. The law firm of d’Oliveira & Associates may be able to help you file a lawsuit against the manufacturers of Celexa, Lexapro, Paxil, Prozac, or Zoloft to compensate for your child’s autism spectrum disorder. Please contact the law offices of d’Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.

DePuy Hip Replacements Recalled Due to Extremely High Failure Rates

2011-06-09T12:24:00.000-07:00

ASR and ASR-XL models recalled for defects, Pinnacle model likely defective

DePUY ASR & ASR-XL MODELS:

On August 24, 2010, the United States Food and Drug Administration recalled the DePuy ASR and ASR-XL hip implants. These defective products had been implanted in hip replacement patients since 2005, and they were recalled because one in eight recipients of the defective device needed surgery to replace or correct the implant within five years of receiving it. This is an extremely high rate of failure for a medical product, and is particularly concerning because patients had to undergo multiple extensive and painful surgeries and rehabilitation.

The implants are failing due to loosening and misalignment of components. The metal-on-metal design of the implants that are misaligned causes metal in the implant to flake off and enter the bloodstream of the person with the implant.

In addition to unnecessary, painful revision surgeries, recipients of these defective implants have experienced cobalt and chromium toxicity from metal in the bloodstream, which can cause vision impairment and hearing loss. The DePuy ASR hip implant can also cause infection in the area of the implant, fracture of the bone, dislocation of the joint, swelling, nerve damage, tissue damage, and muscle damage. If you or a loved one have been the recipient of the recalled ASR or ASR-XL hip implant manufactured by DePuy, you have the right to file a lawsuit against DePuy to seek compensation for your injuries, and the personal injury attorneys at The Law Offices of d’Oliveira & Associates can help you.

THE DePUY PINNACLE MODEL:

DePuy manufactures several different models of hip replacements. In addition to the recalled ASR and ASR-XL models, they also manufacture the Pinnacle model. The Pinnacle model has been on the market since 2002, and the ASR and ASR-XL models have been used since 2005.

Shortly after being introduced to the market, DePuy received complaints that the DePuy Pinnacle model was defective as early as 2002. Since then, many patients and doctors have reported problems with the DePuy Pinnacle model that are similar to the problems with the ASR and ASR-XL models.

There are concerns that the Pinnacle hip replacements may have failure rates similar to the ASR and ASR-XL models, which had failure rates of 13%, roughly 1 in 8 patients.

Although the DePuy Pinnacle model has not yet been recalled, many recipients of the DePuy Pinnacle implant have filed lawsuits against DePuy. With the ASR-and ASR-XL models, the FDA did not recall the defective product until one year after the first lawsuit against DePuy for the ASR models. Even though the Pinnacle model has not been recalled, if you have the Pinnacle implant, you may have the right to file a lawsuit against DePuy, and the personal injury attorneys at The Law Office of d’Oliveira & Associates can help you.

WHAT TO DO IF YOU THINK YOU HAVE RECEIVED A DePUY IMPLANT

The manufacturers of the defective hip implants are using aggressive tactics to contact implant recipients and try to convince them not to participate in a lawsuit against DePuy. This is soley to protect the financial interest of the DePuy company, who manufactured these defective products. If you or a loved one have experienced any pain from either a Pinnacle or ASR/ASR-XL hip replacement, call the Law Offices of d’Oliveira & Associates now, so that we can help make sure your interests are protected.

We can help you find a personal injury attorney to assist you in making important personal and legal decisions. A personal injury lawyer can help you assert your rights and get you the compensation that you deserve. Email us or call us now for FREE case evaluation. For your convenience, our telephones are answered 24 hours a day and 7 days a week (1-800-992-6878). CALL NOW.

Shocking Medical Malpractice Statistics

2011-06-09T10:53:00.001-07:00

Medical malpractice attorneys often wish they could turn back the clock and reverse their clients’ medical malpractice injuries. While that’s not possible, we can help our clients to receive the compensation they deserve for their pain and suffering, wage loss, medical bills, and other damages.

Sometimes medical malpractice can lead to death, and a medical malpractice attorney will help the family who lost their loved one to receive compensation for that devastating loss.

If you or a loved one has suffered injury at the hands of a medical professional, call us, the Law Offices of d’Oliveira and Associates, P.C., now, for a free, confidential case evaluation (1-800-992-6878).

What is medical malpractice?

Medical malpractice occurs when a medical professional breaches a duty of care to a patient, and that breach causes injury to the patient.

In other words, medical malpractice means that the professional acted without due care or didn’t follow standard protocols applicable to the medical profession (i.e. the medical professional was negligent).

There are three elements of proof in a successful medical malpractice case

1. We will help you to show that a medical professional had a duty to exercise due care AND

2. That medical professional failed to exercise due care AND

3. You (or your loved one) were hurt.

Shocking medical malpractice statistics

Medical malpractice kills 225,000 people each year (National Institute of Health).

12,000 people die each year from unnecessary surgery (New York Times).

Just 2% of all people injured file legal claims for compensation (Healthgrades study).

Preventable medical errors in hospitals killed 195,000 people in 2002.

The side effects of medication kill 106,000 people annually (Journal of the American Medical Association).

50% of all medical malpractice legal claims are filed against surgeons (Bureau of Justice Statistics).

1,500,000 people suffer injury or death from medication errors each year (Institute of Medicine).

3,529 medical malpractice payment reports were made against physicians in Massachusetts 1990-2003 (2003 Annual Report, National Practitioner Data Bank, US DHHS).

849 medical malpractice payment reports were made against physicians in Rhode Island 1990-2003 (2003 Annual Report, National Practitioner Data Bank, US DHHS).

Who commits medical malpractice?

While surgeons are the most likely to be sued for malpractice, malpractice can be committed by any medical professional including a: doctor, nurse, pharmacist, athletic trainer, nursing assistant, physician’s assistant, physical therapist, occupational therapist, dentist, orthodontist, or anyone else working in the medical profession.

Where can I get help if I’ve been injured by a medical professional?

The Law Offices of d’Oliveira and Associates, P.C., are prepared to help if you or a loved has been injured by any medical professional. We will work to get you the compensation payments you deserve.

We understand what it takes to navigate the medical, legal, and insurance systems. We can handle all the tedious paperwork and all of the legal hoops so you don’t have to.

If you think that you may have a medical malpractice claim, email us or call the Law Offices of d’Oliveira and Associates now for FREE confidential case evaluation. For your convenience, our telephones are answered 24 hours a day and 7 days a week (1-800-992-6878).

Labor and Delivery Errors

2011-06-03T06:11:00.000-07:00

We, at d’Oliveira and Associates, P.C., know that if your baby has suffered a birth injury, you might be wondering whether labor and delivery errors contributed to your baby’s suffering. We understand that you are upset, stressed, and scared. We help people like you every day. Here is some information to help you. It’s about labor and delivery errors that result in birth injuries.

Types of birth injuries

Clavicle fractures (broken collarbone)

Brachial plexus injuries (Erb’s Palsy and Klumpke’s Palsy; nerve damage)

Femur fractures (broken thigh bone)

Bruising

Subconjunctival hemorrhage (blood in the eye)

Caput succedaneum (swelling of the head)

Cephalohematoma (bleeding between bone and its fibrous sheath covering)

Facial paralysis

Brain damage (brain damage is the leading cause of Cerebral Palsy)

Signs labor and delivery errors may have caused your baby’s birth injury

Medical personnel indicating that something during your labor and delivery should have been done differently or that something shouldn’t have happened as it did.

If your baby is admitted to the neonatal intensive care unit (NICU).

A medical specialist visits your baby.

Forceps or vacuum extraction were used .

Your baby was either blue at birth or did not cry at birth.

Your baby scored low on the Apgar test. Apgar scores range from 1 to 10, with 10 being the highest possible score.

A cesarean is performed after hours and hours of attempted natural delivery.

The umbilical cord was wrapped around your baby’s neck during delivery.

Your baby’s heart rate dropped during delivery.

The baby has to stay in the hospital more than one night.

You and your baby can receive financial compensation for medical malpractice as well as for pain and suffering.

Where to get help

If you suspect that labor and delivery errors may have caused your child’s birth injuries, call d’Oliveira and Associates, P.C. today (1-800-992-6878). We understand the legal, medical, and insurance systems and can help you to receive the financial compensation you need and deserve.

Your legal consultation and case analysis are absolutely free. And, you don’t pay any legal fees or case expenses unless we get money for you.

The statute of limitations – don’t miss the deadline

You must file your medical malpractice claim before the state mandated time limit expires. The time limit is called the “statute of limitations.” If the statute of limitations expires, your claim and your baby’s claim, will be forever barred. This means that you will not be able to recover for medical expenses, pain and suffering, and other potential life-long expenses.

What should you do if you think your baby has suffered birth injuries due to labor and delivery errors? Protect your baby’s rights, pay your bills, and keep more money in your pocket. Email us or call us now for FREE case evaluation. For your convenience, our telephones are answered 24 hours a day and 7 days a week (1-800-992-6878.) CALL NOW.

Over-The-Counter Drugs Abuse

2011-05-23T06:36:00.000-07:00

Misuse of over-the-counter drugs has increasingly lead to overdose. This may seem shocking to some, as these medications are easily accessible. Many people believe that these drugs are harmless because they can be found almost anywhere, and can be purchased by almost anyone. However, these over the counter drugs contain hidden dangers and can be life-threatening. Such over the counter pain relievers and other medications have lead to a growing incidence of overdose.

In fact, in Florida, the Poison Information Center has reported a sharp increase over the past ten (10) years in the receipt of calls concerning over-the-counter products. Such reported health products included ibuprofen, acetaminophen- the ingredient found in cold medicines and pain relievers, including Tylenol, other cough and cold medicines, and vitamins.

Some experts have speculated that the reason for the increase in overdose from over-the- counter medications stems from the expense associated with doctor’s visits. If a patient does not have health insurance, a visit to the doctor’s office can be extremely expensive. Such a high expense may discourage patients from going to see a medical professional. Instead, they may self-medicate with drugs that they can easily, quickly, and cheaply pick up at any drug store, grocery store, or convenience store.

Unfortunately, one man who had no insurance, but suffered from a painful toothache decided to self-medicate with acetaminophen. As a result of taking matters into his own hands, the man suffered from liver and kidney failure. His consumption of four pain reliever pills at a time contributed to him organ failure. Symptoms of his over-use of these medications culminated in abdominal pains and vomiting, and ultimately ended with his death.

Many people remain unaware of the hidden dangers of drugs such as Tylenol and ibuprofen. It is difficult to believe that over the counter medications, particularly very popular medications, can lead to death. However, acetaminophen, the drug found in Tylenol, is the leading cause of acute liver failure in the United States. Acetaminophen has resulted in many serious overdose cases, including more than 400 deaths a year, according to the U.S. Food and Drug Administration (FDA).

As a result of recent studies and a more thorough investigation into the dangers of acetaminophen, the FDA, as of January, has decided to limit the amount of acetaminophen allowed in certain prescription drugs. This limit, which will be applicable to painkiller pills such as Vicodin and Percocet, will likely take effect in about three years. Although a restriction has been placed on these prescription pills, which contain a combination of narcotic painkillers and acetaminophen, the FDA has not yet taken any action regarding limitations on the amount of acetaminophen permitted in over-the-counter medications. Thus, higher dosages of acetaminophen may be available in over-the-counter medications than available by prescription in certain instances.

Where to get help

What do you do if you or a loved one has been injured or killed as a result of taking certain over the counter medications such as Tylenol? Call the Law Offices of d’Oliveira & Associates now. A personal injury attorney familiar in the investigation of acetaminophen and other dangerous over-the-counter drugs can help you get the compensation you deserve. The attorneys at the Law Offices of d'Oliveira & Associates are affiliated with some of the best and most experienced pharmaceutical lawyers in the country. The Law Offices of d’Oliveira & Associates can provide you with the legal representation you need, to help you make important personal and legal decisions. Email us or call us now for FREE case evaluation. For your convenience, our telephones are answered 24 hours a day and 7 days a week (1-800-992-6878). CALL NOW.

For More Information Concerning Dangerous Over the Counter Medications Click Here:

Links to

Tylenol web page

Nexium web page

Prilosec web page

Chronic Beryllium Disease (CBD): A Continuing Threat

2011-03-21T13:04:00.000-07:00

Chronic Beryllium Disease (CBD) affects several hard working Americans each year. What is even more unfortunate is that there is no cure for CBD. Because the signs and symptoms of CBD may take years to develop, a person may not even know that they have been exposed to beryllium and face an increased risk of developing lung tissue scarring. Here is some information concerning CBD that you may find helpful.

CBD is caused by the inhalation of beryllium dust or fumes. CBD can result in painful scarring of the lung tissue. Beryllium is a naturally occurring lightweight material. Beryllium is stiffer than steel but lighter than aluminum. Typically, beryllium is packed away in solid rock and soil composition. Thus, one does not develop beryllium sensitization from casual beryllium exposure outdoors because such natural air concentrations are very low. Rather, beryllium sensitization commonly occurs from exposure to persons who work in the aerospace, dental, electronics, atomic, or defense industries. Beryllium is used in these industries because it is a good thermal and electric conductor, is non-magnetic, and is extremely lightweight and hard. Other industries and occupations that frequently use and may expose a person to beryllium include:

Ceramic manufacturing
Laboratory work
Mineral extraction
Metal recycling
Fluorescent lamps
Sporting goods
Welders
Machinists
Hot press operators

You may not have any apparent signs of CBD, particularly in its early stages of development. However, some possible symptoms of CBD may include:

Fatigue
Night Sweats
Feeling short of breath after physical activity
Loss of appetite
Recurring dry cough
Joint and Chest pain
Skin rash
Fever

Persons with CBD first develop “beryllium sensitization,” an allergic response to beryllium. In the later stages of the disease, scarring of the lung tissue occurs. Severe lung damage may cause the right side of the heart to be strained as a result of excessive pressure in the pulmonary artery from lung damage. CBD can develop as quickly as within one month of exposure to beryllium, but may take as long as forty years to develop or materialize.

Beryllium has also been shown to cause cancer in humans. Studies have indicated that an increased risk of lung cancer is especially likely for individuals exposed to very high levels of beryllium. Although there is a risk of cancer resulting from exposure to beryllium, the more common concern associated with beryllium exposure is beryllium sensitization and CBD. These ailments are frequently diagnosed, likely because many workers have been exposed to low levels of beryllium over a long period of time. Families of workers in the above named occupations and industries may also become exposed to dangerous levels of beryllium as a result of contact with the worker’s clothing, hair or body.

Unfortunately, there is no cure for Chronic Beryllium Disease, and it may be fatal. There are certain treatments that may be used to slow the progression of the disease. Such treatments can help a person to manage CBD symptoms by improving oxygen levels in the bloodstream and preventing further lung damage from scarring.

In serious cases of CBD, a lung transplant may be necessary. Other treatment options may include the use of oxygen therapy or immunosuppressive drugs. Oxygen therapy helps patients who have increasing difficulty breathing on their own. Oxygen therapy provides supplemental oxygen and can be delivered through systems including concentrators, compressed gas systems, and liquid systems. The immunosuppressive drug most often prescribed to patients with CBD is prednisone. Prednisone works to slow the immune system’s response to beryllium in the blood and helps improve the gas exchange between the lungs and the bloodstream. Such treatment is usually given as a regimen and the use of prednisone is gradually decreased over time. Prednisone therapy can work to decrease CBD symtoms.

Where to get help

What do you do if you think you or a loved one has been exposed to beryllium, and has suffered from Chronic Beryllium Disease as a result? Call the Law Offices of d’Oliveira & Associates now. Our firm can help families just like yours. We will work aggressively to assert your rights and get you the compensation you and your family need and deserve. Email us or call now for FREE case evaluation. For your convenience, our telephones are answered 24 hours a day and 7 days a week (1-800-992-6878). CALL NOW.

Tylenol Poses Serious Risks, Including Death!

2011-02-28T11:58:00.000-08:00

Since Tylenol (acetaminophen) is available over-the-counter and is conveniently accessible, many would think that the drug is relatively safe. Tylenol is usually available in most major drug stores, small pharmacies, grocery stores, and other locations. Several people have relied on Tylenol as their go-to pain reliever whenever they experience symptoms of a common cold, fever, headache, and menstrual pains, just to name a few medical ailments. However, as many consumers recently have discovered, Tylenol may not be as safe as one would expect, particularly for a drug that is so readily available.

Acetaminophen is the general (generic) name for Tylenol, which is a brand name. Typically, a person’s bodily chemicals will bind with the toxin in Tylenol, and this process will render that toxin harmless. However, sometimes too much of the toxin becomes present in a person’s body, such that their body cannot detoxify the full scope of the chemical.

Many times, Tylenol is overlooked as a cause of liver damage. The U.S. Food and Drug Administration (FDA) requires Tylenol, as well as other acetaminophen drugs, to carry a warning label to ensure that patients who consume three or more alcoholic drinks per day consult a physician before they begin an acetaminophen regimen. However, certain persons who are not eating normally may also be at an increased risk of liver damage even when properly following the label’s directions. Those persons who are not eating regularly and are taking Tylenol or acetaminophen may suffer liver failure in as little as four days to one week. This risk is not warned against on Tylenol’s labels.

Tylenol’s manufacturer, Johnson & Johnson, has long been aware of the toxicity and dangerousness that acetaminophen can pose. However, for many years Johnson & Johnson has never publicized, through warning labels or other measures, the fact that some persons may suffer liver damage as a result of taking Tylenol.

Millions of people nationwide use painkiller medications which contain acetaminophen but are unaware that this drug can cause serious side effects including liver damage, liver failure, and even death. Acetaminophen is the most commonly used painkiller in the country. Americans take over 8 billion pills (tablets or capsules) of Tylenol each year.

From 1998 to 2003, acetaminophen was the leading cause of acute liver failure in the United States. Some signs of liver damage or liver failure may include: loss of appetite, nausea, vomiting, fatigue, fever, jaundice and dark urine.

As a result of these serious health effects, the FDA has recommended that the amount of acetaminophen in any medication be reduced. In January 2011, the FDA took the additional step of mandating a “black box warning” for the label of certain prescription medications. This warning will highlight the potential for severe liver injury on all prescription drug products containing acetaminophen.

If you have suffered livery injury as a result of using Tylenol, you may be entitled to compensation. You should not have to suffer through your injuries alone. A personal injury attorney can be by your side to assert your rights and make large drug manufacturers aware that they cannot get away with hiding the severe risks that their products pose. If you need further information on Tylenol or would like an attorney to review your case, please fill out contact form at our web site: http://tylenol-lawsuit-lawyer.com/

Dangerous Multaq Side Effects

2011-02-25T05:29:00.001-08:00

Liver Damage and Liver Failure Associated with Multaq

If you are a patient who has experienced paroxysmal or atrial fibrillation (AFib) or atrial flutter type conditions, the drug Multaq (Dronedarone) offered the hope of a reduced risk of cardiovascular hospitalizations. Multaq is a drug sold by the international pharmaceutical company Sanofi Aventis. On its website, Sanofi claims that Multaq can work to lower the “chance that you would need to go to the hospital.” What Sandofi’s website failed to inform you, however, was that the drug poses serious risks to patients taking it, including the risk of severe liver injury. It was not until September 2010 that Sandofi’s website warned consumers “you should not take Multaq if you have severe liver problems.”

On July 14, 2011, the U.S. Food and Drug Administration (FDA) warned patients that Multaq has been linked to an increased risk of acute liver failure and other liver problems. To make matters worse, the drug was approved only a few years ago, in July 2009, which suggests that the FDA and large drug manufacturers such as Sanofi Aventis have failed to ensure that their products are safe before they enter the mainstream U.S. market. In fact, it has been estimated that almost 150,000 people have been prescribed this heart medication since just October of 2010.

Multaq is used to treat patients who have had an abnormal heart rhythm during the past six months including patients with conditions such as atrial fibrillation or atrial flutter. Because of this increased risk if liver injury, new warnings and information are now being added to the Multaq label. Signs of liver injury resulting from the use of Multaq may include: vomiting, fever, anorexia, nausea, fatigue, jaundice, pain in the upper right quadrant, dark urine, and general weakness or discomfort.

The FDA has received several reports of liver injury and hepatic failure in Multaq users, including two cases of acute liver failure in patients using the drug, who then needed a liver transplant. Patients now have to weigh the benefits of Multaq, which include a decreased risk of hospitalization for heart conditions, against Multaq’s risks, which include a risk of severe liver damage and/or liver failure to a previously well-functioning liver.

Patients were once able to rely on the advice and information given by their doctors and drug manufacturers to weigh the risks and benefits of a particular drug. As the recent case of Multaq and its dangerous side effects indicate, however, now consumers must do their own research and investigation into a drug’s risks if they do not want to be seriously harmed by a medication. Oftentimes, medications will be placed on the market prior to proper warnings being made available to patients or published on a drug’s labels. If you have taken Multaq and suffered liver damage as a result, you may be entitled to compensation. You should not have to suffer for shortcomings on the part of drug manufacturers and the FDA. If you need further information on Multaq or would like an attorney to review your case, please fill out contact form at our web site: http://multaq-lawyer.com/

Dangerous Risk of Anesthesia Revealed!

2011-01-28T09:31:00.000-08:00

Current statistics indicate that 1 out of every 200,000 patients dies as a result of anesthesia complications. In April 2009 the journal of the American Society of Anesthesiologists, Anesthesiology, reported that 2,211 deaths related to anesthesia occurred in the United States between 1999 and 2005. Additionally, according to data from 2000, the National Healthcare Quality report has indicated that approximately 0.724 incidences of anesthesia complications per 1,000 surgical discharges occur in the United States.

A common concern among patients is that they will not be 100% unconscious and will “wake up” while undergoing a surgical procedure as a result of some error in the administration of anesthesia. Mayo clinic has reported that out of every 1,000 people who are under general anesthesia, approximately 1 or 2 wake up while in surgery. This can occur as a result of an anesthesiology specialist’s failure to use correct methods or devote the necessary attention to proper practices in administering anesthesia. In making such errors, hospital personnel may contribute to this partial awareness in patients during surgery.

Such “anesthesia awareness” usually means that the quantity of anesthesia administered does not keep a person unconscious. However, the quantity is enough to prevent that person from making noise or moving. Typically, patients experiencing “anesthesia awareness” also can hear what is going on around them. When experiencing “anesthesia awareness” a person may not feel pain, however, sometimes unbearable pain is suffered or experienced. Anesthesia & Analgesia published a study which found that 28 percent of patients who experience anesthesia awareness will feel the pain of surgery. Additionally, the data from the study indicated that one half of patients will hear conversations in the operating room. Furthermore, the study indicated that half will feel as if they are unable to breath. Some people have suffered serious psychological problems as a result of being put through such a traumatizing experience. The Joint Commission on Accreditation of Healthcare Organizations has indicated that 21,000 to 42,000 Americans experience anesthesia awareness each year.

Anesthesia errors, including failure to prevent anesthesia awareness, may occur for a number of reasons. Typically, however, such errors are due to professional negligence. Some of the most common anesthesia mistakes include dosage error, either because the anesthesia product is incorrectly labeled or because an anesthesiologist makes a mistake and gives a patient too much or too little anesthesia. Issues with anesthesia may occur because of: delayed delivery of anesthesia because of leakage, IV error, or syringe issues; failure to intubate in order to help a patient breath safely; inadequate monitoring of patients; and errors in the recognition of complications. Anesthesia complications may also result from: leaving a patient unattended; turning off the alarm which monitors the level of oxygen in a patient’s blood and alerts medical professionals as to potential concerns; negligent administration of oxygen during surgery; a medical provider’s usage of drugs or alcohol; errors in communication between medical professionals and between medical providers and patients; defective equipment; and prolonging sedation for a dangerous amount of time.

A number of serious complications can arise from the improper administration of anesthesia. These complications may result from toxic effects and include: abnormal breathing, abnormal heartbeat, abnormal blood pressure, nerve damage, heart or lung problems, stroke, and heart attack. Anesthesia complications can even cause brain damage, long-term coma, or death.

Improper anesthesia administration is a serious problem and your concerns as a patient must be addressed. Large hospitals and hospital personnel should not be able to make critical mistakes without being held responsible. It is extremely important that those professionals administering anesthesia to patients, as well as those professionals monitoring patients during surgical procedures, are well qualified.

References:

http://www.wrongdiagnosis.com/a/anesthesia_complications/stats.htm

http://www.webmd.com/pain-management/tc/anesthesia-risks-and-complications

http://www.oshmanlaw.com/medicalmalpractice/anesthesia-errors-malpractice.html

http://thesafetyreport.com/

If you or a loved one has suffered a complication with anesthesia please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.

Severe Birth Defects Associated With Depakote!

2011-01-14T07:55:00.000-08:00

Certain medications offer hope to consumers that their medical conditions will be treated in a safe and effective manner. Depakote was one of those medications. Depakote once was regarded as a break through medication for the treatment of epilepsy and manic episodes for patients with bipolar disorder. Consumers also looked to Depakote as a solution to their migraine headaches or neuropathy conditions. Depakote offered hope to patients who suffered from these medical impairments.

However, many consumers, particularly persons who were pregnant when taking the drug Depakote, did so without the knowledge that this medication poses serious medical risks. Depakote may have devastating effects for mothers who used the drug during pregnancy. Severe and permanent birth defects may arise in newborns and children whose mothers used Depakote. Studies have indicated that the side effects are the most severe if a woman took the medication during the first month of pregnancy. However, mothers who used Depakote for other time periods during pregnancy also may face the risk of similarly dangerous side effects. The risks posed by Depakote are so serious that the U.S. Food and Drug Administration (FDA) has required the manufacturers of Depakote, Abbott Laboratories, to update the drug’s safety label several times. Such safety label revisions were required in order to accurately reflect the dangerous risks that Depakote poses.

Depakote (divalproex sodium and/or valproic acid) was approved for the treatment of epilepsy in 1983 and was approved for the treatment of manic episodes in patients suffering from bipolar disorder in 1995. In 2006 the FDA required a black box warning (the strongest warning the agency can give) for Depakote. The black box warning cautioned that the serious risks which Depakote poses to unborn fetuses may outweigh the benefits of the drug. Additionally, the black box warning cautioned consumers that Depakote may also pose an increased risk of liver failure and pancreatitis to patients who use the drug.

For women who took the drug Depakote during their first trimester of pregnancy, the medication has been identified as posing the risk of severe birth defects in developing children. More common birth defects associated with the use of Depakote include spina bifida, cleft palate limb malformation, and genital malformation. However several studies have indicated that Depakote side effects may include any of the following serious medical impairments:

Cleft palate
Hand deformations
Undescended testes
Hypospadia (opening of the urethra in the wrong place)
Heart malformations
Limb reduction and/or deformities
Dysplastic (abnormally developed) ribs
Fetal death
Neural tube malformations
Spina bifida
Genital malformations

Spina bifida occurs when the embryonic neural tube is not completely formed. This neural tube malformation results in the child having an opening in the vertebrae, leaving their spinal cord exposed. Many of the side effects associated with Depakote are considered life threatening and irreversible. A child could potentially suffer from a non-fatal birth defect for the rest of their lives. Not only does Depakote pose a serious risk to children who have been exposed to it, but also Depakote poses the risk of pancreatitis and liver failure to those who have taken it.

If you are a woman who took Depakote during pregnancy or a young adult who has suffered from birth defects you should be entitled to remedial action. The permanent consequences of the drug manufacturer’s failure to warn of serious Depakote side effects should not be placed on you alone. It is important that the drug manufacturer’s inadequate labeling process be remedied, and that the large drug manufacturer is held responsible for its incomplete disclosure of the dangerous side effects posed by Depakote.

If you need further information on Depakote or need an attorney to review your case, please fill out contact form at our web site http://depakotesideeffect.com.

FDA Waits Over Fifty Years to Pull Fatal Drug Darvon From the U.S. Market

2010-11-24T11:42:00.000-08:00

For almost two decades, Darvon (propoxyphene) was one of America’s most popular prescription drugs. Propoxyphene came on to the United States market as a prescribed painkiller in 1957. From 1973 to 1975 the number of prescriptions issued for Darvon averaged 39 million per year. In fact, in 2004 Darvon was the 12^th most prescribed drug in the United States. One would think that, with a drug that has been on the U.S. market for over 50 years, any side effects associated with such drug would be minimal. If a medication has been around for over 50 years, it must be safe, right? Unfortunately, this is not necessarily true, as evidenced by the recent recall of the drug Darvon.

The medication Darvon, as well as other prescriptions drugs containing propxyphene, have faced public criticism for some time. Concern over medications containing propxyphene first arose after the drug was associated with 589 overdose deaths in 23 U.S. cities. In fact, one Health Research Group declared the drug “the deadliest prescription drug in the United States.”

In February 2006, the Public Citizen actually urged the FDA to ban both Darvon and Darvocet. However, despite various studies indicating the dangerous side effects associated with Darvon, and the vast public outcry over concern of propxyphene’s dangerous side effects, the U.S. Food and Drug Administration (FDA) refrained from taking any remedial action with regard to the drug. It was not until November 19, 2010 that the FDA called for the ban of the drug Darvon.

Darvon (Darvon N 100 mg) also known as Darvon N 100, and Darvocet is the brand name of the generic prescription pain drug propoxyphene. Darvon is an opioid painkiller used to treat mild to moderate pain and is typically used by patients who have undergone or are undergoing surgical procedures. The FDA has asked that all manufacturers of medications containing propoxyphene refrain from marketing those painkillers. The FDA initiated the Darvon recall after it examined several clinical studies which indicated that drugs containing propoxyphene pose the risk of fatal cardiovascular side effects. Other dangerous side effects associated with Darvon and other drugs containing propoxyphene include: overdose, suicide, heart palpitations, cardiovascular abnormalities, death, fainting, lightheadedness, and dizziness.

The FDA has concluded that the risks posed by the drug Darvon, and other drugs containing propoxyphene, outweigh the benefits provided by such medications.

Xanodyne Pharmaceuticals Inc., the company that manufactures Darvon, has agreed to remove the medication from the market as a result of the FDA’s request. Other manufacturers of generic drugs containing propxyphene have also agreed to remove their products from the market.

However, this action by the FDA, in initiating the Darvon recall, may have come to late. The FDA should have taken more stringent measures to ensure the safety of Darvon to patients prescribed the drug. The FDA should have paid more attention to the public outcry over Darvon’s dangers and the reasons for this outcry. The FDA needs to be held accountable for the fact that clinical data and studies were presented to it over a series of years. Such studies indicated the risk of fatality associated with Darvon and other prescription drugs containing propxyphene. Despite this clear evidence of Darvon’s dangers, the FDA sat aside and did nothing. How many deaths did the drug manufacturers and the FDA require propxyphene to produce before it took action? Why should people lose their lives over a dangerous drug’s side effects when such deaths and adverse health consequences could have been prevented long ago?

Fifty years is far too long to wait to take precautionary measures to ensure that dangerous and fatal medications are not accessible to consumers and patients. In light of the numerous public complaints over propxyphene, stemming from when the drug was first introduced into the market, it is difficult to hypothesize what is necessary for the FDA and large drug manufacturers to put consumer safety first.

If you need further information on Darvon/Darvocet or need an attorney to review your case, please fill out contact form at our web site http://www.darvon-lawsuit-lawyer.com.

AlloDerm: High Failure Rate And Risk Of Serious Complications

2010-11-15T07:28:00.000-08:00

At one time, the product AlloDerm was praised by doctors and patients as a safer alternative to normal skin grafting procedures. However, in light of recent reports of the product’s frequent rate of failure, it might be the case that AlloDerm is actually significantly more dangerous than other techniques which are similarly used to regenerate skin.

What’s even more shocking about the consequences of this product is that most patients are never informed that AlloDerm will be used during their surgery, and only find out that AlloDerm has been used after their medical procedure has been conducted.

AlloDerm was introduced onto the market by the bioengineering company LifeCell in 1994. Alloderm is used to help grow skin over areas of the body which have been damaged because of injuries or surgery. AlloDerm is processed skin tissue taken from deceased donors. The processing used in the manufacture of AlloDerm enables living cells to be removed from the skin and thus presents a reduced chance that a patient’s body will reject the graft. AlloDerm differs from a traditional skin graft in that traditional skin grafts are performed with skin that has never been processed for the removal of live cells.

AlloDerm is primarily used in medical procedures such as hernia repairs, breast reconstruction following mastectomies, treatment for severe burns or lacerations, and head and neck plastic reconstruction and grafting

Recently, AlloDerm has been identified as causing serious medical complications. Dangerous consequences resulting from the use of AlloDerm have been reported to include:

Life-threatening infections
Abscesses
Bruising and contusions
Swelling
Recurrence of hernia
Extreme discomfort
Repeat corrective surgeries

Notably, AlloDerm has been associated with complications in the treatment of hernias which typically are addressed by repair to the opening in the muscle wall. Serious medical problems may occur when the mesh product AlloDerm is used to repair hernias. One study has reported that the overall complication rate associated with AlloDerm hernia repairs is a high 24%. The most frequent problems associated with the use of AlloDerm in hernia treatment include: explanting mesh as a result of recall, mesh perforation, mesh tear, mesh erosion, defective mesh, and adhesion problems.

You or your family members should not have to fall victim to painful problems arising from the unsuccessful use of AlloDerm. Furthermore, the doctors who utilized the product AlloDerm without your knowledge should not be permitted to get away with putting the burden of the failure of this product on you, an innocent patient. It is vital that patients become fully informed concerning medical procedures that will be performed on their bodies and the risks that such procedures may pose. Doctors must fully inform patients concerning medical procedures and products with which they are unfamiliar, so that they can make meaningful choices in terms of their health. Additionally, manufacturers of medical products, like LifeCell, must ensure that if their product poses any serious risks to patients, patients become informed of such risks.

Fosamax: For Some, Additional Warnings Come Too Late

2010-10-22T10:14:00.000-07:00

When a product enters the mainstream market, many people assume, and reasonably so, that such a product would have undergone sufficient testing. However, it is often the case that a drug is placed on the market before that drug has been tested properly. Since testing measures often are inadequate, manufacturers find themselves forced to change the drugs’ label warnings often, usually upon the insistence of the FDA. It is questionable whether manufacturers of such drugs would voluntarily change such labels, if not asked to do so by the FDA, as to avoid any controversy or public backlash as to inadequacies on the drugs’ initial label warnings.

When drug manufacturers fail to thoroughly test drugs, and, in doing so, fail to place warnings on the drugs’ labels which adequately reflect a particular drugs’ risks, consumers are harmed. The medication Fosamax is a prime example of manufacturers’ lackadaisical manner of ensuring that a drug’s safety requirements are reflected in drug label warnings before the drug is placed on the U.S. market.

It recently has been discovered that Fosamax side effects include an increased risk of developing atypical fractures of the thigh in patients taking the drug will. Such atypical fractures, which include atypical subtrochanteric femur fractures- fractures in the bone just below the hip joint, and diaphyseal femur fractures- fractures occurring in the long part of the thigh bone, are associated with Fosamax and bisphosphonates generally. These types of fractures are very uncommon and are estimated to account for less than 1% of all hip and femur fractures overall.

Fosamax is a drug used for the treatment and prevention of osteoporosis. It is manufactured by Merck, and was approved by the FDA in 1995. However, in March 2010, the FDA announced that it would be investigating a possible link between the drug Fosamax (alendronate), and a particular type of leg fracture. It is shocking that this drug has been on the market for over fifteen years, and yet this very serious risk of bone fractures was never reflected on the drug’s safety label.

Popular bisphosphonates medications which may place patients at an increased risk for developing femur fractures include Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast. On October 13, 2010, the U.S. Food and Drug Administration (FDA) announced that it would require new warnings to be placed on the labels of the above-mentioned medications. The label changes are to be added to the drugs’ Warnings and Precautions section and will reflect the increased risk of atypical fractures of the thigh associated with bisphosphonates.

Because of the inadequacy in these manufacturers’ testing procedures and, consequentially, inadequacy in warning labels, the FDA has had to take stringent measures by alerting the public of this increased risk of femur fractures through alterations to the drugs’ labels. Consumers should have been warned of these serious risks of fractures over fifteen years ago, when the drug Fosamax first entered the market.

Due to manufacturers’, including Merck’s, shortcomings in discovering any risks associated with Fosamax and other bisphosphonates medications, the public has suffered. Consumers and patients who decided to take the drug may have declined to take the drug had they known the manner in which their health and safety was at risk because of the drugs’ side effects. If we want consumers and patients to be able to make meaningful medical decisions with their physicians, we need to ensure that they have all the information. Allowing manufacturers the freedom to perform the amount of safety testing that they see fit puts patients’ health at risk. A slap on the wrist through the FDA by implementing drug label changes is not enough to vindicate the rights of patients who have been harmed by large drug manufacturers. It is important that safety testing procedures are thorough, and, in turn, that medication safety labels reflect a medication’s risks from the moment a particular drug enters the mainstream U.S. market.

Weight Loss Products; Profits Over Safety When It Comes To Meridia

2010-10-22T06:58:00.000-07:00

Weight loss increasingly is a priority for Americans. Weight loss often is a topic of conversation among friends, a topic for New Years resolutions, and a topic which constantly appears in advertisements on the television and the web. Many people have a desire to lose weight for a number of reasons. These reasons may include an aspiration to become healthier, a need to address particular medical problems associated with being overweight, or a mere motivation to “look better” or be perceived as more attractive.

As weight loss increasingly has become a goal for a number of Americans, big business has taken advantage of this popular subject matter. By capitalizing on weight loss products ranging from exercise machines, to gym memberships, to surgical procedures, to supplement pills, large companies throughout the country have made it a priority to advertise to and reap the benefits of individuals’ good faith motivations to lose weight. Unfortunately, large profit companies typically consider their own monetary interests as a priority, rather than the health of the customers and clients who may choose to use such companies’ products.

The situation referred to above, in which large companies may fail to take the necessary safety precautions before marketing a product in order to gain profits, is precisely what happened with regard to the weight loss supplement, Meridia. Meridia (sibutramine hydrochloride) is a prescription only weight-loss supplement for obese patients with risk factors including diabetes, high cholesterol, and controlled blood pressure. The FDA approved Meridia in November of 1997. However, in January 2010, the FDA notified healthcare professionals of recent data that identified adverse cardiovascular risks linked to the use of Meridia, particularly for those patients with a history of cardiovascular disease.

Following this initial notification, on October 8, 2010 the FDA sent out notice that it was advising against any continued use of the drug Meridia. This warning followed additional recent studies linking the drug to life-threatening cardiovascular problems, including stroke, heart attack, and death.

Furthermore, in going beyond merely warning consumers of the life-threatening risks associated with Meridia, the FDA requested that the drug’s manufacturer, Abbott Laboratories, voluntarily recall Meridia from the United States market. This request was, in part, due to the severity of the risks associated with Meridia. Additionally, the FDA has stated that the risk for adverse cardiovascular side effects from Meridia outweighs the modest weight loss benefits associated with the drug. Thus, Abbott Laboratories, the drugs’ manufacturer, has agreed to refrain from marketing Meridia in the United States.

The drug is sold in 70 countries and it is estimated that 8.5 million people use Meridia worldwide. Therefore, several people have been exposed to Meridia’s adverse risks. Such serious side effects associated with Meridia should not be taken lightly. Large drug manufacturers should be punished for failing to test their products thoroughly enough to reveal any safety risks. Moreover, the FDA is also at fault for giving its approval to place the drug on the market. For thirteen years, Meridia has been accessible to vulnerable individuals who merely would like to better themselves and their quality of life by losing weight, due to the irresponsibility of large drug companies and the FDA. Such irresponsibility should not be rewarded by continued ability to market dangerous drugs. Rather, to prevent similar dangers from entering mainstream American consumers’ lives, drug companies need to be reprimanded severely enough in order to deter them from making similar mistakes, which jeopardize individuals’ health, in the future.

DePuy Misleads The Public, Consumers Suffer

2010-10-20T10:29:00.000-07:00

Hip replacement surgery itself is a painful, time-consuming process. The decision to undergo this surgery is not an easy one. The procedure usually requires months of recovery time in order for a patient to return to normal activities. Patients who have made this difficult decision have relied both on the hip replacement devices that will become a part of their body and on their physicians’ discretion. Patients often have supposed that, although the hip replacement process will be painful at first, in the long run, will make them better off.

Despite many individual’s reasonable belief that hip replacement surgery is the best decision, disturbing reports recently have emerged, indicating that a specific type of hip replacement system may be unsafe. These reports indicate that several individuals who have had defective hip replacement devices implanted during their surgery will now have to undergo additional surgeries in order to correct the dangers arising from the defective devices, manufactured by DePuy Orthopaedics.

Total hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant. This joint replacement orthopaedic surgery is performed for various reasons, including hip fracture treatment, or to reduce arthritis pain.

The DePuy ASR hip replacement system has been identified as posing serious risks to implant recipients, including hip failure and dispersal of metallic debris in patients’ bodies. About 93,000 people worldwide have used the devices that are now being recalled because of their high failure rate and, in consequence, the need for repeat corrective surgeries. Following DePuy Orthopaedics’ (a subsidiary of Johnson and Johnson) market withdrawal of the DePuy ASR hip replacement system, and warning to clinicians concerning failure rate information, the U.S. Food and Drug Administration (FDA) has designated the manufacturer’s actions as a Class 2 medical implant recall.

The DePuy ASR is a metal-on-metal hip replacement system. Metal-on-metal hip implants increasingly have been associated with various health risks because they are known to disperse metal particles into the body. This shedding of particles can cause tissue damage and deterioration, inflammatory reactions, and can lead to bone loss. Studies have shown that approximately 12 to 13 percent of patients that have undergone hip replacement surgery with DePuy devices will need corrective or replacement surgery within five years to remedy dangers caused by the metal debris.

DePuy should be reprehended with regard to its actions and irresponsible conduct in this matter. In fact, DePuy had tried to downplay the seriousness of the dangers associated with its devices by initially indicating that the market withdrawal of its products was due to slow sales rates, rather than critical safety issues. The FDA needs to take more action to ensure that large manufacturers, like DePuy, cannot misrepresent the safety of their products at the expense of a consumer who lacks certain vital informational channels. DePuy should have taken responsibility for its products’ failure early on, rather than misleading the public. Until the FDA betters its process for review of medical manufacture’s devices, and until large manufacturers are reprimanded for their irresponsibility, the average consumer will continue to suffer.

Revealed: Actos No Safer Than Avandia

2010-09-08T19:16:00.000-07:00

For years, consumers relied on the false representation that the Type-2 diabetes medication, Actos (pioglitazone), was a safer alternative than the competing drug, Avandia. This belief arose in large part from misinformation by drug companies and the U.S. Food and Drug Administration (FDA) that Actos posed less of a risk of dangerous side effects. Based, in part, on this misinformation, sales of Actos rose to $4.6 billion in 2010 while sales of Avandia plummeted from $3.4 billion in 2006 to $1.1 billion in 2010. However, reports have recently emerged suggesting that Actos, in actuality, is no safer than Avandia. In fact, Actos poses about the same risks as Avandia to users of the drug. The FDA is only now acknowledging that serious cardiovascular side effects, even death, can result from the use of Actos.

In 2007 it was suggested that the FDA knew about Actos’ cardiovascular risks but failed to take any remedial measures. In fact, the FDA became subject to criticism by several health care professionals and lawmakers for failing to take corrective action or warn consumers about the dangers of Actos. In several instances, the FDA was even asked to place black box warnings on the Actos label by, among others, drug safety advisors, but nevertheless failed to do so.

The FDA has now asked the manufacturers of Actos to issue a black box warning identifying the dangerous cardiovascular side effects associated with the drug. The black-box warning is the strongest warning that the FDA can request to be put on a medication label. The FDA has also taken on a serious investigation into the dangers of Actos to determine whether a drug recall is necessary. Adverse cardiovascular events linked to Actos have been reported to include heart failure, heart attack, and death caused by a compromised cardiovascular system. Since the disease of Type-2 diabetes itself also increases the risk of cardiovascular disease, any adverse cardiovascular complications have been of particular concern to diabetes patients.

Actos (pioglitazone) is manufactured by Takeda Pharmaceutical Company. In the United States the oral diabetes medication is co-marketed by Eli Lilly Pharmaceuticals. Actos became FDA approved on July 15, 1999. Type-2 diabetes medications such as Actos work by lowering an individual’s glucose levels and reducing the body’s tissue insulin resistance. Actos is in a class of medications called Thiazolidinedione drugs, which are believed to be the strongest drugs available for the treatment of Type-2 diabetes.

The FDA needs to take more seriously the evidence of dangerous side effects of medications brought to its attention by professionals. Particularly, as here, when suggestions are made by the FDA’s own agents and drug safety advisors, the FDA should make an effort to incorporate those suggestions so that the health of all consumers is maintained as a high priority. Consumers should have the opportunity to receive the most information possible before making the decision to take any drug. Although the FDA is now investigating whether place a drug recall on Actos, and has encouraged the placement of a black box warning on Actos’ label, this safety action may have come too late for several consumers. The FDA needs to take safety precautions, early on, and mandate responsible efforts by drug manufacturers to ensure that any dangerous side effects of a medication no longer go unidentified and undetected.

ZOCOR: Popular Cholesterol Lowering Medication Linked To Serious Muscle Injury

2010-07-14T07:20:00.000-07:00

Many Americans face the problem of high cholesterol levels in their blood. Having above average cholesterol levels may lead to increased health risks or health problems including heart disease, chest pain, stroke, and heart attack, among other things. For this reason simvastatin, under the brand name Zocor, is a popular medication for several individuals. Zocor is in the class of drugs called statins. Statin drugs are used to lower plasma cholesterol levels. Although many statin medications carry a risk of muscle injury, also called myopathy, the need for lower cholesterol levels typically is worth the risk for most people.

However, the U.S. Food and Drug Administration (FDA) recently warned consumers about a severe case of muscle injury that has been associated with the drug Zocor. This severe case of muscle injury is called rhabdomyolysis, and is the most serious form of myopathy. On March 19, 2010, the FDA warned patients and health care providers that Zocor 80 mg has been linked to rhabdomyolysis as a serious side effect.

Zocor was FDA approved in December of 1991. Zocor is used to reduce the amount of cholesterol and other fatty substances in the blood. Simvastatin works to slow the production of cholesterol in the body. Zocor 80 mg is the highest approved dose of the simvastatin medication and therefore presents a higher risk of muscle injury than do lower doses of simvastatin and other statin drugs. The risk of developing myopathy becomes greater as the dose of the statin used is increased. If simvastatin is used in combination with other drugs, the risk of developing muscle injury may also increase.

Symptoms of myopathy include muscle pain, tenderness or weakness, and elevated levels of the muscle enzyme found in blood (creatine kinase). Symptoms of rhabdomyolysis, associated with the use of Zocor, include dark or red urine, fatigue, muscle pain, tenderness or weakness, and kidney failure, which can be fatal. The risk of developing rhabdomyolysis increases if an individual is aged 65 years or older, has low thyroid hormone levels, or has poor kidney function.

The manufacturers of Zocor, the FDA, and doctors would likely all suggest that patients need to be more responsible in assessing the risks and benefits that a particular drug carries, and deciding whether to take that drug accordingly. While it is true that consumers must take seriously the warnings and possible side effects associated with medications, drug manufacturers, the FDA, and doctors must also be responsible in protecting consumers from dangerous drugs on the market. In the case of Zocor, patients need to know the risk associated with consuming the highest approved dose of simvastatin. The manufacturers of Zocor, the FDA, and doctors should all take more responsibility in an effort to make patients more aware of the risks associated with the medication, and, in turn, better able to make an informed decision concerning whether to take the drug.

IUDs: Internationally Obtained, Non-FDA Approved Devices Discovered in Rhode Island

2010-07-12T08:24:00.000-07:00

Typically, a patient will trust, or at least give consideration to, their personal doctors’ input concerning which medical devices are the best and most effective for that particular patient. That is exactly what several individuals did in Rhode Island. Various patients who visited OB-GYN Associates, Inc. offices took their doctors’ word that the pregnancy prevention device recommended to them would be both safe and effective. However, these patients were unaware that certain Rhode Island OB-GYN Associates, Inc. offices had been purchasing and using non-FDA approved intrauterine devices (IUDs) from international sources.

After conducting a lengthy investigation of its Board of Medical Licensure and Discipline, the Department of Health discovered that, since January 2009, several OB-GYN Associates, Inc. offices in Rhode Island had been purchasing and using non-FDA approved versions of Mirena and ParaGard. The intrauterine devices under the brand names Mirena and ParaGard have been FDA approved. The use of drugs and devices, which have not been approved by the FDA, typically is prohibited by law, except under very specific circumstances.

An IUD is a small, “T-shaped,” flexible, plastic device that is inserted into a woman’s uterus to prevent pregnancy. The IUD Mirena also acts to deliver a small amount of hormones into a woman’s body to increase the effectiveness of pregnancy prevention. Often, women choose the IUD method of birth control because such a device is long lasting and inexpensive.

The R.I. Department of Health has become concerned about the effectiveness of the non-FDA approved IUDs in preventing pregnancy. On June 23, 2010, the R.I. Department of Health issued a compliance letter to OB-GYN Associates requiring that practice to stop inserting IUDs. The Department then received reports that various other OB-GYN practices had been purchasing and using unapproved IUDs obtained from international sources.

The R.I. Department of Health is requiring any OB-GYN practices that have been using non-FDA approved IUDs to notify all patients who have had such devices implanted. Additionally, the Department has confiscated all IUDs in stock at the Rhode Island offices of the OB-GYN Associates, Inc. practice.

To prevent any unintended consequences resulting from the use of unapproved IUDs, consumers who have been using intrauterine devices should ask their doctors if the birth control method they have been using is FDA-approved. Patients should be aware that several practices which have been using non-FDA approved IUDs have not yet been identified, and should continue to check the R.I. Department of Heath website for updated information and reports. Finally, patients should be aware that IUDs which have not been FDA approved may not be as effective at preventing pregnancy, and should speak with their doctors about taking precautions accordingly.

Wellbutrin: A Danger During Pregnancy

2010-06-28T09:10:00.000-07:00

Pregnant women often face the difficult decision of whether to take antidepressants and risk the possibility of birth defects, or forgo depression treatment altogether. If certain women do not take care of depression during pregnancy, they may put themselves and their unborn child at risk. A pregnant woman who does not address depression may find it difficult to provide the optimal prenatal care and healthy lifestyle an unborn child needs to thrive. However, several medications used for the treatment of depression have been associated with fetal health problems.

In the United States, approximately one in six mothers is diagnosed with a major depressive disorder and is put on an antidepressant drug. Pregnancy often generates emotions that can make depression more difficult to manage. Bupropion, placed on the market by manufacturer GlaxoSmithKline as Wellbutrin, is a popular drug for the treatment of depression. Bupropion is also used as a smoking cessation aid under the brand name Zyban. However, Wellbutrin potentially could cause harm to an unborn child.

The U.S. Food and Drug Administration (FDA) approved Wellbutrin in December 1985. However, in May 2010 reports of a possible link between the antidepressant drug and cardiac birth defects surfaced. Such reports appeared in the American Journal of Obstetrics & Gynecology and indicated that about two out of every 1,000 women who took bupropion during the first trimester of their pregnancy faced an increased risk of heart birth defects. Additionally, the research team determined that of the babies born with a heart defect, 0.5 percent of the mothers reported using bupropion during the month prior to pregnancy or in their first trimester. The researcher’s findings emerged from the observation of over 12,700 babies born in the U.S. between 1997 and 2004. Data indicated that babies born to mothers who took bupropion in early pregnancy experienced more than double the risk for specific heart defects as compared to babies whose mothers did not take the drug.

Drug manufacturers GlaxoSmithKline and SmithKline Beecham generated worldwide sales revenues of over $1.1 billion from the drug Wellbutrin in 2001. Yet such manufactures clearly have not expended adequate funds on research to identify serious risks associated with the use of the popular antidepressant drug. Only after twenty-five years of consumers utilizing the drug unknowing of its risks, are researchers beginning to warn of the very real danger which Wellbutrin presents to pregnant mothers and their unborn children. However, this delayed identification of such birth defect risks associated with Wellbutrin is of no consolation to consumers who have already taken the drug, unaware of the possible negative side effects it may have. As a result of inadequate research efforts, the public has been placed unnecessarily in harm’s way.

Drug manufacturers, such as GlaxoSmithKline, need to expend more efforts to identify the potential negative side effects of the drugs it places onto the market so that consumers who use such drugs can be adequately informed of a drug’s risks. Once consumers become aware of the risks that a drug like Wellbutrin carries, they can make a more informed medical and personal decision concerning whether to take that drug. To effectively facilitate consumer knowledge and awareness, drug manufacturers need to engage in more research efforts. Engaging in such efforts surely will help drug manufacturers to meet the expectations of the public. More importantly, adequate research and health risk identification will prevent many people from being unnecessarily injured by dangerous drugs like Wellbutrin.

Click here for more information on Wellbutrin or to contact an attorney.

Prilosec, Nexium, and Prevacid: The Link To Bone Fractures Ignored Too Long

2010-06-04T08:34:00.000-07:00

For years, patients with chronic heartburn had a quick and easy solution to take away that burning feeling in their chest- or so they thought. Acid blocking pills, a class of drugs called proton pump inhibitors (PPIs), which include the commonly known medications Prilosec, Nexium, and Prevacid were a quick fix for many who experienced painful heartburn symptoms. Individuals suffering theses painful symptoms were enticed to continue to take these medications because often, their painful acid reflux symptoms would return when the pills weren’t taken. However, early studies indicated that over time these medications could be bad for a person’s bones. Unfortunately manufacturers of these medications and federal regulators did not take notice of these early studies soon enough.

The U.S. Food and Drug Administration (FDA) approved Prilosec in September of 1989, Prevacid in May of 1995, and Nexium in February of 2001. It was not until May 25, 2010, that the FDA warned consumers and health care professionals about a correlation between PPIs and the possibility of an increased risk of hip, wrist, and spine fractures. Federal heath regulators only recently began to warn doctors and patients that certain popular heartburn drugs are likely to cause an increased risk of bone fractures when used for more than a year.

PPIs act to decrease the amount of acid produced in the stomach and are used to treat symptoms of gastroesophageal reflux disease (GERD), stomach ulcers, small intestine ulcers, esophagus inflammation, and frequent heartburn. PPIs are available both by prescription and over-the-counter. Common prescription PPIs include; Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimovo. Common over-the-counter PPIs include; Prilosec OTC, Zegerid OTC, and Prevacid 24HR. High doses or long-term uses of Prilosec and other antacid (PPIs) make an increased risk of bone fractures more likely.

In May of 2010 the FDA mandated a label revision for both over-the-counter and prescription PPI’s to reflect the increased risk of bone fractures associated with PPIs. However, it is likely that many already have experienced bone fractures as a result of taking PPIs and never were adequately informed about this risk. PPIs block the stomach from producing hydrochloric acid, but such acid helps the body absorb calcium. Calcium is a key ingredient in bone health and researchers have theorized that the drugs' acid-blocking effect may speed up bone loss.

The required label revisions came about after the FDA reviewed seven published studies, six of which reported an increased risk of fractures of the hip, wrist, and spine with the use of PPIs. Most of the studies evaluated individuals 50 years of age or older, and the increased risk of fracture was seen mainly in this age group. Additionally, studies indicated that those at greatest risk for fractures received high doses of PPIs or used them for one year or more.

Many individuals, in essence, wanted to stay on their heartburn medications forever to avoid any painful symptoms that may have re-emerged if they decided to stop using PPIs. They continued using these medications without being adequately informed of the risks associated with the chronic use of PPIs. When individuals begin to use over-the-counter or prescription medications, they should be informed about any information they need to be able to make an informed personal decision about a drug they may choose to take. Individuals who used Prilosec, Nexium and Prevacid never had a chance to make an informed decision, because they were never warned of the risk of bone fractures associated with the drug’s usage.

Despite studies indicating an association between PPIs and an increased risk of bone fractures, they FDA did not mandate a warning reflecting such a risk until only recently. To enable consumers to avoid a drug’s dangerous side effects, individuals should first ask their doctors about any possibility that a drug may affect their body in a negative way. Second, manufacturers should perform necessary research to assess the risks and benefits of a drug, and alert the public as to this information. Finally, federal regulators should take reliable research studies seriously early on, so that medications’ warning labels can be accurate, and consumers can be fully informed as soon as a medication enters the marketplace.

Brand name vs. Generic: Getting what you Pay For at the Pharmacy

2010-04-19T08:10:00.000-07:00

A trip to the local supermarket often forces us to make some choices. For any given product, there are many options to choose from. Typically, only a couple of those options are considered brand name products, while the rest are considered generic. Whatever the product may be, the consumer usually wonders if they will get the same brand-name quality if they were to buy the generic version. Ultimately, the decision is guided by cost. The consumer may decide to pay less for the generic version because they expect it to be either identical or close enough to the quality of the brand name. However, other consumers might argue, “you get what you pay for”. These people are weary of the generic version, and will pay the extra money to ensure they are getting the quality product they are looking for. Today, people taking a trip to the pharmacy are also faced with the same decision, the choice between brand name and generic. Unfortunately, the decision to pay less may result in serious health problems.

Levetiracetam, an anticonvulsant medication, is a prime example of a generic drug that may cause its users to have serious health problems that have not been found with the use of its brand name counterpart. Keppra is the brand name drug used in the treatment of epilepsy for both adults and children. It was approved by the U.S. Food and Drug Administration (FDA) in 1999. Belgian drugmaker UCB Pharma Inc. is the manufacturer of Keppra. Their patents for Keppra, the brand name anticonvulsant medication, recently expired in 2009. Soon after the Keppra patents expired, several pharmaceutical manufacturers began producing cheaper, generic versions of Keppra.

Many pharmaceutical companies often begin making generic versions of brand name drugs because they can turn a good profit. Their products will be cheaper than the brand name because their company does not need to pay all the expenses associated with developing and marketing the drug. After a few of the pharmaceutical companies produce and sell the drug, the prices will begin to drop because all of the companies will be competing to be the cheapest.

Generic medications are tested and compared with their brand names. The FDA reviews the data to determine if the generic products are equivalent to the brand name. If they are, the FDA will assign an AB rating to the generic version. The FDA has given an AB rating to Levetiracetam, finding it to be the equivalent of brand name Keppra. Therefore, the generic versions are expected to provide the same quality and results as the brand name drugs. Although generic medications may be found by the FDA to be the equivalent of the brand names, this does not mean they are identical in composition. In fact, generic medications may contain some differences in inactive ingredients. The most common inactive ingredients that may differ in generic drugs are fillers or dyes. These ingredients may cause the patients to have allergic reactions or other side effects not experienced by them with use of the brand name drugs.

Mylan Pharmaceuticals is the producer of Levetiracetam, one of the generic versions of Keppra. The lower price tag for Levetiracetam has led many consumers to choose this generic brand. Also, many patients have begun purchasing generic Keppra because their insurance plans will no longer allow the name brand. However, without realizing it, patients who have switched to the generic brand may actually be putting themselves in harm's way because Levetiracetam has been linked to serious side effects. Patients who have been seizure free for long periods of time, years in some cases, have reported experiencing seizures after switching to the generic medication. Other patients have reported migraines and light-headedness. Any of these side effects may result in serious consequence if the patient is alone or operating a vehicle at the time of a reaction.

More often than not, a generic drug will perform just as effectively as the brand name. However, although rare, there are instances where patients may experience an allergic reaction or suffer serious side effects by taking the generic version instead of the brand name drug. To prevent these dangerous consequences, people should first ask their doctors if the generic drug they are taking has been known to produce any side effects or allergic reactions. Second, when people go to their local pharmacy to get their medications, they should ask their pharmacist the same question. Finally, patients should be aware that if they decide to pay less, they may be putting their health at risk. After all, in the case of Keppra and its generic counterpart (Levetiracetam), “you get what you pay for.”

Avoidable Hospital Infections: Clean Hands may Save your Life

2010-03-22T10:34:00.000-07:00

When an individual decides to go to a hospital for medical care, they expect to get better. Regrettably, there are many instances in which patients actually become even more sick after entering the hospital. To make matters worse, the simple act of washing one’s hands could have easily prevented the patient from experiencing this declining state of health. When hospital staff members fail to wash their hands, patients are at risk of getting potentially fatal hospital-acquired infections (sometimes referred to as HAI).

Resources for the Future, a think tank (company or group that conducts research and reports their findings), recently published a study in the Archives of Internal Medicine journal that showed avoidable hospital-acquired infections killed 48,000 American patients in 2006 alone. To put this number in perspective, Americans are three times more likely to die from a hospital-acquired infection than from HIV. The researchers examined 69 million discharge records from 1998 to 2006. The records were taken from various hospitals in 40 states. To ensure their data represented only hospital-acquired infections, the researchers excluded from their study any infections that were present before hospital admission. The study also showed that these infections increased health care costs by a staggering $8.1 billion dollars. The researchers conducting the study paid particular attention to two common hospital-acquired infections, sepsis and pneumonia.

The study concluded that patients who developed sepsis (a blood infection) remained in the hospital for an extra 11 days. The approximate cost to treat each person’s sepsis infection was $33,000. Although the additional cost associated with treating sepsis is already troubling, the number of people who die from this infection is frightening. Almost 20% of patients with sepsis die. Similarly, the research data on pneumonia indicated that patients would remain hospitalized for an additional 14 days, with costs totaling to approximately $46,000 per patient. Furthermore, 11% of patients died from the pneumonia infection. The most common types of hospital-acquired infections include urinary tract infections, surgical-site infections, sepsis, pneumonia, and MRSA (Methicillin-resistant Staphylococcus aureus).

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The best way to treat hospital-acquired infections is to stop them before they happen. Specifically, there is one proven method for preventing hospital-acquired infections that is both easy and straightforward: hand-washing. Hospital staff members should practice good hygiene and follow sanitation guidelines. They should wash their hands before treating different patients. Also, hospital personnel should only be using sterilized equipment on patients. Furthermore, any physician or doctor examining a patient should be encouraged to wear gloves. If hospital staff members were to practice all of these precautionary measures, infection rates would be greatly reduced. With a simple solution being available, there is no excuse for hospital staff negligence that could lead to such dangerous consequences.

Although we would like to think that hospital staff members always take the necessary steps to keep patient safety a number-one priority, the reality is that patients cannot rely solely on the hospital staff to do what is right. Patients and their family members can also help prevent hospital infections. Before even deciding which hospital to visit, a patient should ask their doctor how often bloodstream infections occur there. Patients should also ask if all staff members are required to wash their hands before entering the room. Another helpful preventative measure is for a patient with a catheter to ask daily if their catheter can be removed because catheters are a common risk for infections. Also, patients should try to ensure that before any staff member touches their catheter, they wash their hands.

As disturbing as it may be, patients should be aware that when they check into a hospital for even minor medical treatment, they might be putting themselves in harm’s way. Although hospital-acquired infections are very dangerous, they are not unavoidable. By simply washing their hands, the hospital staff can do what they are supposed to do, save lives.

Yaz (Yasmin): Bayer Chose Profit over Public Health

2010-01-06T07:46:00.000-08:00

Despite the many serious dangers associated with the drug, Yaz was America’s number one selling oral contraceptive in 2008. According to the New York Times, Bayer (manufacturer of Yaz/Yasmin) made approximately $616 million dollars domestically and $1.8 billion dollars in global sales off those products. These staggering numbers demonstrate why Bayer must not have been concerned in late 2008, when the FDA cited two Yaz commercials for deceptive advertising. As a result of the FDA’s warnings, Bayer had to spend about $20 million dollars to run corrective ads. That number certainly seems to be only a minor setback given the incredible profit they have made with Yaz/Yasmin.

Yaz/Yasmin is a once daily oral contraceptive. Although they are two separate drugs, Yaz and Yasmin are almost identical in chemical composition. Yasmin was introduced onto the market in 2001, receiving FDA approval in May of that year. Yaz received FDA approval in 2006. Both Yaz and Yasmin contain a synthetic progesterone called drsp (drospirenone). Drospirenone increases the user’s potassium level. This increased potassium level can lead to hyperkalemia (abnormal potassium level in the bloodstream). Hyperkalemia can cause arrhythmia (potentially fatal heart rhythms) and also increases the risk of developing gall bladder disease. In fact, the FDA has received information indicating that many of the deaths in women who were taking Yaz resulted from increased potassium levels.

Other serious side effects associated with Yaz/Yasmin include heart and cardiovascular problems, strokes, deep vein thrombosis (DVT), thromobophlebitis (vein inflammation from a blood clot), and pulmonary embolism (blood clot in the lungs). The British Medical Journal released two studies showing that when compared with other contraceptives, Yaz and Yasmin are more likely to cause blood clots. In fact, the study reports that Yaz/Yasmin users are 6.3 times more likely to suffer blood clots. The study attributes this elevated risk to the presence of drsp (drospirenone). As a result of these dangerous side effects, Public Citizen, a consumer advocacy group, placed Yaz/Yasmin on its “Do Not Use” list.

Although Yaz’s primary purpose is to prevent pregnancy, Bayer also claims it treats symptoms of PMDD (premenstrual dysphoric disorder) and moderate acne. Beginning in March 2006, Bayer ran a large marketing campaign that targeted women in their twenties. The slogan of the campaign was “beyond birth control”. The campaign also consisted of two commercials, which created an enthusiastic scene set to lively rock songs: “We’re Not Gonna Take It” and “Goodbye to You”. These advertisements falsely suggested Yaz is approved for relieving premenstrual syndrome (PMS). The commercials suggested that women’s PMS symptoms would be suppressed although that had not been proven. Yaz was only FDA approved for treatment of symptoms of premenstrual dysphoric disorder (PMDD), which differs from premenstrual syndrome. PMDD can cause women to have tension, constant anger, and anxiety.

After examining Bayer’s marketing campaign, the FDA issued them a warning letter on October 3, 2008. The FDA’s warning letter cited the two Yaz commercials for deceptive advertising. The letter reprimanded Bayer for overstating and exaggerating the benefits of the birth control pill and also for deemphasizing the serious side effects associated with its use. The FDA said, “these violations are concerning from a public health perspective because they encourage the use of Yaz in circumstances other than those in which the drug has been approved.” According to the FDA, the commercials’ images were fast paced and the music was distracting, particularly at points where the drug’s serious side effects were being described. In summary, the TV advertisements deceptively stretched the indication of the drug.

In an effort to reconcile with the FDA, Bayer began running corrective advertisements in early 2009. The TV ads were part of an agreement that Bayer reached with the FDA and 27 state attorneys general. These ads were a positive step moving forward. However, making the assumption that Bayer has taken more responsibility for its’ actions would be a mistake. In fact, the FDA recently issued an additional warning to Bayer regarding Yaz/Yasmin. In August 2009, the FDA warned them about poor quality control at a German plant that produces drospirenone used in Yaz. Bayer continues to lack concern for health and safety.

Bayer’s deceptive advertisements for its birth control pills, Yaz and Yasmin, should serve as two important lessons for consumers. First, not everything you see and hear on television is true. Second, consumers need to make smarter health decisions because pharmaceutical companies like Bayer are more likely to choose profit over public health.

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Reglan: Taking Responsibility for the Chronic Use of Reglan

2009-12-28T12:36:00.000-08:00

Often times when something goes wrong, it is easy to place the blame on one individual. For example, in sports, the coach is often the scapegoat, getting fired for a team’s poor play. However, it is much more likely that one individual is not at fault for any given problem. Therefore, everyone involved should share the blame and responsibility. Patients should not be the only individuals responsible for suffering the consequences of the chronic use of Reglan. The manufacturers of Reglan, the FDA, and doctors and physicians have “dropped the ball”. They should take responsibility.

Reglan (metoclopramide) is a drug created by manufacturers to treat acid reflux disease, heartburn, gastroesophageal reflux disorder and some symptoms of diabetic gastroparesis. Reglan helps to induce muscle contractions in the upper digestive tract. This elevates the rate at which the stomach empties into the intestines. The drug comes in different forms: tablets, oral solution, and injection. Because metoclopramide is the leading cause of drug-induced movement disorders, Reglan has been recommended only for short-term use. Generally, patients should use the drug for just 1-3 months to avoid serious side effects.

The chronic use of Reglan (anything over three months) has been found to cause a neurological disorder called tardive dyskinesia. Similar to Parkinson-like symptoms, patients with tardive dyskinesia suffer from involuntary and repetitive movements throughout their body. There are many symptoms that result from tardive dyskinesia, including: facial tics and grimacing, lip smacking, repeated eye movements, restless leg syndrome, and tongue protrusion. Perhaps the most alarming fact about tardive dyskinesia is that the disorder is often irreversible. People will suffer from the disorder for the rest of their lives. This is especially troublesome when considering studies suggesting children and infants are more susceptible to developing tardive dyskinesia than adults.

The manufacturers of Reglan must surely be held responsible for any dangers that may occur from the use of their product. As the FDA has reported, many Reglan users suffer from tardive dyskinesia. In fact, FDA data has showed that nearly 30% of patients using Reglan for over a year develop the drug-induced movement disorder. This clearly suggests that manufacturers of Reglan did not adequately warn people of the very serious risks associated with the chronic use of their product. Manufacturers need to perform more research and studies on the potential risks their products may cause before making them available to the public.

In an effort to make people aware of the risks evident from the chronic use of Reglan, the United States Food and Drug Administration ordered a Black Box Warning for the drug in late February 2009. This warning is the most severe warning the FDA gives. Although this FDA action was a step in the right direction, it should have been done sooner. It is crucial that the FDA promptly warn people of the risks of taking any drug. In the case of Reglan, it is even more important given that it may lead to an irreversible disorder.

According to the FDA, over 20% of Reglan users take the drug for more than three months. Any doctor or physician who prescribes Reglan for a period of time longer than three months is condoning a potentially dangerous use of the drug. Unfortunately, the patients will be those suffering as a result of the harmful misuse. Also, it has been reported that over two million Americans have been prescribed Reglan. This fact suggests two things. First, patients often trust and follow the professional judgment or recommendation of their doctors. Second, doctors are likely being too quick to recommend Reglan. Reglan should be used as the last available option to treat gastroesophageal reflux because the possibility of developing tardive dyskinesia.

The manufacturers of Reglan, the FDA, and doctors would all likely suggest that patients need to be more responsible, reading labels and determining the risks for any drug they consume. While it is true that patients should be careful before they begin any medication, it is also true that manufacturers, the FDA, and doctors owe a duty of care to those patients. When it comes to taking risks, patients are on a need-to-know basis. In the case of Reglan, patients need to know the risks of chronic use. The manufacturers, the FDA, and doctors should take more responsibility in an effort to make patients aware.

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Levaquin: Evidence of the FDA’s Shortcomings

2009-12-28T12:26:00.000-08:00

According to the U.S. Food and Drug Administration (FDA), it is their responsibility to advance the public health by “helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” The FDA attempts to fulfill this responsibility with the expectation that the public will heed their warnings. However, the public has expectations as well. People expect the FDA to do their job admirably and that requires them to also listen when they are warned. Similar to a patient ignoring a doctor’s orders, the FDA’s neglect may result in harm. The FDA did not adequately respond to the warnings they received of risks associated with taking Levaquin (Levoflaxacin). As a result, many patients using Levaquin have suffered from tendon ruptures and tendonitis.

Levaquin or Levoflaxacin, an antibiotic manufactured by Ortho-McNeil Pharmaceuticals (a subsidiary of Johnson & Johnson), is often prescribed to treat a wide variety of bacterial infections that target the lungs, skin, and urinary tract. Additionally, Levaquin is sometimes used to treat chronic bronchitis and pneumonia. The purpose of the drug is to eliminate the bacteria or prevent its’ continued growth. This treatment assists the patient’s body in fighting off the infection. Levaquin comes in different forms, including: tablets, oral solution, or injection. Soon after its release on the market, the FDA approved Levaquin in 1996. However, the FDA failed to warn the public about the hidden dangers of Levaquin.

Since its’ release thirteen years ago, several accredited medical journals, including The Journal of the American Board of Family Medicine and The Journal of Orthopedics Traumatology, released studies which revealed individuals who had taken Levaquin suffered tendon ruptures. Reports indicate tendon ruptures and tendonitis to be the most frequent side effects of Levaquin. The ruptures usually occur in the Achilles tendon, but may also occur in the shoulder, bicep, hand, and thumb. Often times, patients may not experience any symptoms before the rupture occurs. These ruptures can happen while patients are actively taking Levaquin and in some instances, months after they have stopped.

In 1996, a consumer advocacy organization named Public Citizen petitioned the FDA to issue Levaquin warnings. The FDA granted the petition but issued a warning that was not clearly evident on the labels. Ten years later, Public Citizen again tried to persuade the FDA to enhance the warning labels for Levaquin in an effort to make the public aware of the risk of tendon ruptures. The consumer advocacy organization even had the help of the Illinois Attorney General’s Office. The petition requested the FDA issue a black box warning because of the hidden dangers of Levaquin. During this decade of inaction, there were close to 1,000 reported cases of tendon ruptures and tendonitis. By the FDA’s estimation, Levaquin is reported to have been the cause of over 60% of those injuries. Two more years passed after the second petition was filed before the FDA responded.

On July 8, 2008, the FDA finally responded to the warnings they had been hearing for twelve long years. The FDA issued a black box warning to Levaquin’s packaging. In addition, patients are also to be given medication guides that would warn them of the tendon ruptures that occur with use of Levaquin. Although the black box warning is the most severe warning the FDA can issue, this warning is certainly no consolation to the many victims of Levaquin who have already undergone surgery and exhaustive rehabilitation. As a result of the FDA’s inaction, the public was unnecessarily placed in harm’s way.

If the FDA truly intends to fulfill their duty to protect the public, they need to realize they are not driving down a one-way street. To effectively improve the public health, they must perform two tasks. First, they must warn the public of any dangers they are aware of. Second, they need to listen and respond appropriately to the warnings they are given. Performing these tasks will surely help the FDA become better suited to meet the expectations of the public. More importantly, it will prevent many people from being unnecessarily injured by dangerous drugs like Levaquin.

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Stevens-Johnson Syndrome (SJS): A Deadly Allergic Reaction

2009-12-23T08:21:00.000-08:00

People often take precautionary measures to avoid triggering their allergies. If someone is allergic to peanuts, they simply don’t eat them. If someone experiences allergic reactions when they are around certain animals like cats or dogs, they do their best to avoid them. However, difficulties arise when we do not yet know what may cause us to have allergic reactions. Unfortunately, this is often the case with the life threatening disorder, Stevens-Johnson Syndrome (SJS).

Stevens-Johnson Syndrome is a rare disorder that occurs in the skin and mucous membranes. It is caused by a severe allergic reaction to medication. The disorder causes people to develop a painful red or purplish rash that spreads and blisters. Eventually, the blistering will actually cause the top layer of skin to die (necrosis) and shed. In some instances, SJS can result in death if skin lesions become infected, or if the lesions develop within the patient’s lungs.

SJS has been linked to many different medications, including over-the-counter drugs, prescription pain relievers, and antibiotics such as Children’s Advil and Motrin. Others medications linked to SJS include: Dilantin, Levaquin, Depakote, and Tegretol. On May 16, 2006, the FDA released new warning labels for several medications to inform patients of the possible risk of developing Stevens-Johnson Syndrome. Various Advil and Motrin products were among the drugs receiving the warning labels. Also, Tolectin Tablets and Tolectin DS Capsules were listed.

SJS is especially dangerous because the early conditions are often common problems many people may disregard as usual nuisances, such as a rash, cough, sore throat, and other flu-like symptoms. However, the complications and symptoms of SJS become much more serious. In fact, patients suffering from Stevens-Johnson Syndrome are typically treated in a hospital’s burn unit. This is often the best place to treat patients with SJS because the blistering that occurs may cause the patient’s skin to peel off in sheets from large parts of the body, much like patients suffering from burn injuries. Depending on a given patient’s condition, recovery from SJS can range from weeks to months.

Patients with SJS have experienced lung damage, dry-eye syndrome, chronic obstructive pulmonary disease (COPD), asthma, scarring of the esophagus, chronic fatigue syndrome, permanent skin damage, and even permanent blindness. Also, it seems that Stevens-Johnson Syndrome can occur at any age. Most cases occur in adults between the ages of 20-40 years old. However, SJS has been diagnosed in children as young as 3 months old.

A more severe form of SJS is Toxic Epidermal Necrolysis Syndrome (TENS). With this disorder, an increased portion of the skin is affected, usually 30% or more. With such a large part of the body’s skin being lost through cell death (necrosis), the patient is susceptible to infection. Infection may lead to sepsis, the leading cause of death for those with TENS.

Allergic drug reactions are the fourth leading cause of death in the United States. In an effort to raise awareness on this life threatening disorder, some states have recognized August to be Stevens-Johnson Syndrome Awareness month. Those states include: Colorado, Arizona, Alabama, Connecticut, and Tennessee.

While we can often take precautionary measures to avoid triggering our allergies, we still may not be aware of other things that may cause us to have allergic reactions. Avoiding the risk of getting SJS is especially difficult because there are so many different medications linked to the cause of the disorder. However, it seems we have some available options.

First, we should try to join the efforts of those states that recognize August as Stevens-Johnson Syndrome Awareness month. This would help educate the public on the risks associated with taking medications that may cause SJS. Second, we should encourage the FDA to continue its research, and provide updated warning labels on any product that may present a risk of Stevens-Johnsons Syndrome. Finally, we must carefully read the labels to learn the risks and complications of any and all medications presented to us. Ultimately, the best method to avoid SJS is the same as avoiding any other allergic reaction: stay alert and be cautious.

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Denture Cream: Hidden Threat?

2009-08-25T09:40:00.000-07:00

Dentures are a common commodity in today’s society; many people with dental problems wear them. What most people don’t realize is that denture creams pose a hidden threat to people who use them regularly. An August 2008 article in the “Neurology” journal found that three of the most popular brands of denture cream- Super Poli Grip, Poli Grip, and Fixodent- all contain high levels of zinc that cause severe side effects when overused. Generally, denture cream consumers are unaware of the threat posed by misuse of the product. Even more alarming is the fact that these same people don’t realize that they are misusing the product.

The manufacturers of these denture creams are not required to, and therefore do not, list zinc as an ingredient in their product. Not only is zinc not listed as an ingredient, but also the manufacturer’s usage directions are incredibly vague. There is no specific amount suggested for usage- there is merely a direction suggesting use “once a day, unless otherwise directed by your dentist.” These vague directions are augmented by a tiny illustration depicting a pair of dentures and where the cream should be applied. Research has shown that using these creams as recommended is not dangerous. The problem is that not many people use it as directed.

Many people who wear dentures find that the dentures do not fit perfectly. Over time our gums shrink and this can lead to problems with fitting of dentures. Instead of replacing the dentures, most people apply more denture cream to compensate. This is where the problem lies. An August 2008 article in the journal “Neurology” said that one tube of denture cream should last anywhere from 3 to 10 weeks. The study also found that most people who reported adverse side effects from denture cream use were using 2 tubes per week. These people are exposing themselves to extremely high levels of zinc. The recommended daily allowance of zinc is 8-11 mg. People using excessive denture cream recorded levels of 330 mg. This exposure eventually leads to zinc poisoning and depleted copper levels in the body.

Symptoms of zinc poisoning include suffering from paralysis, tingling in hands, pain, loss of sensation, muscle weakness in the arms and legs and other neurological problems. Patients also complain of having the sensation of wearing gloves and socks even if their hands and feet are bare.

Zinc poisoning may also lead to a diagnosis of two conditions called dysesthesias and paresthesias. Dysesthesias causes patients to feel itching, burning, wetness, electric stock and the feelings of pins and needles. Their hands and feet feel very uncomfortable, especially when they touch something. Patients may also have lesions on their central or peripheral nervous system. Paresthesias is very similar and includes feelings of warmth, burning itching, cold and skin crawling. Zinc poisoning can also cause anemia, bone marrow failure and neuropathy

It is recommended that denture wearers use caution when applying denture creams. If you currently use Poli Grip, Super Poli Grip, or Fixodent it is recommended that you find a substitute brand. If you insist on using one of these brands it is recommended that you ask your dentist for the recommended usage.

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Raptiva Finally Removed From Market

2009-07-31T12:18:00.000-07:00

July 29, 2009

After many warnings and unfortunately, many cases of serious infections, Raptiva manufacturer Genentech has removed Raptiva from the US market. Although Raptiva is believed to put users at risk for a number of serious infections, the main reason for its removal from the market was the number of cases of progressive multifocal leukoencephalopathy (PML) being reported by users of Raptiva.

A statement made by Genentech said that the drug was expected to be unavailable in the US by June 8, 2009. As a result of this recall, doctors and medical professionals are being asked to refrain from prescribing Raptiva for new patients and discuss transitioning existing patients to alternative treatments.

PML is a very serious progressive neurologic disease that affects people whose immune systems have been greatly weakened. PML often leads to a decline in neurologic function that as of now is irreversible. There have also been a number of cases reported where death has resulted.

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Fosamax Linked to Yet Another Serious Bone Injury

2009-07-29T12:25:00.000-07:00

July 20, 2009

Fosamax, a drug that is used to treat osteoporosis and other bone diseases has been linked to yet another serious bone injury. A June 2008 study published in the Journal of Orthopedic Trauma revealed that patients being treated with Fosamax had a staggeringly higher occurrence of low-energy femur fractures than did those who were not taking Fosamax.

A low-energy fracture is considered a fall from a standing height or less. The study showed a consistent pattern in the breaks- they were usually horizontal breaks with a beak-like overhang on one side. Dr. Joseph Lane, chief of metabolic bone disease at the Hospital for Special Surgery at Weill Cornell Medical College in New York City, said of the femur fractures, “These were peculiar fractures that would occur when the women were basically doing nothing.” The other notable distinction with these injuries was that they were occurring in what appeared to be healthy bone, not osteoporotic bone. This new injury is in addition to the earlier studies that linked long-term Fosamax use to osteonecrosis- decaying of the bone- of the jaw. It is recommended that you speak to your doctor before beginning or ending treatment with Fosamax.

If you have been taking Fosamax for an extended period of time and believe you have one of the injuries described above, please contact us for a free consultation. For further information please click here.

Matrixx Initiatives, Inc. Reeling Over Zicam Voluntary Recall

2009-06-26T07:36:00.000-07:00

The common cold is one of those experiences that all of us experience and one that none of us are very fond of. Stuffy nose, coughing, sore throat, and headache- we all know the symptoms like the back of our hand. We also know that there is no cure for the common cold, only drugs that alleviate symptoms and hasten recovery. Amidst reports of people losing their sense of smell from nasal sprays, gels, etc., the questions we need to ask ourselves are whether these drugs really work and whether they are worth the health risks that some of them pose?

Matrixx Initiatives is in the business of manufacturing over-the-counter drugs to deal with many of these ailments such as the common cold. On June 16, 2009 Matrixx received a warning letter from the U.S. Food and Drug Administration (FDA) notifying them that three of their Zicam Cold Medications were linked to serious health risks including anosmia, also known as loss of sense of smell. The FDA asserted in the letter that the Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs are misbranded for failure to adequately warn of risks associated with their use. The FDA further recommended that Matrixx voluntarily recall the products and prohibited them from further marketing the products without FDA approval.

In a press release dated June 16, 2009 Matrixx Initiatives called the FDA action unwarranted and also reiterated that they had 10 years of manufacturing experience with these drugs and knew that they were safe for consumer use. In a later press release dated the same day, Matrixx again reaffirmed their earlier position that the action was unwarranted while simultaneously announcing its voluntary recall of the products in question.

Zicam nasal sprays and gels are zinc-based intranasal remedies. For many years it has been known that zinc-based remedies cause loss of sense of smell in humans and animals. These types of remedies are homeopathic and thus not required to be regulated by the FDA. This has led to the expansion of their use recently. It is debated whether these treatments are even effective in treating nasal congestion. Recent studies have shown that zinc-based products are minimally effective at best, with one study showing complete ineffectiveness.

If the health risks associated with zinc-based products are so well known, we can assume that the good people at Matrixx knew about them. So, why did they manufacture and market a product they knew was likely to cause harm to some patients? More importantly, why, even after warnings from the FDA, do they continue to release statements defending the products? The answer should come as no surprise to anyone; it is money. The voluntary Zicam recall may end up costing Matrixx upwards of $10 million and force the company to downsize. Matrixx says that it will lose an estimated $5 million in lost sales and another $5 million will need to be spent in advertising to reach out to consumers. Matrixx is afraid of the adverse effect the recall will have on sales of their other products as well. Matrixx has already seen the effects of the recall on Wall Street seeing its stocks drop daily.

What is Matrixx’s solution? Fight the FDA on this issue and seek permission to continue manufacturing and marketing the products. But hey, a couple hundred cases of anosmia is acceptable when you’re making millions, right? Wrong. The FDA also released information about an additional 800 cases of anosmia that were reported to Matrixx but that they initially withheld from the FDA. So, what we have here is a multi-billion dollar company manufacturing and marketing products that they know are dangerous for consumers. Further, in the face of pressure from the FDA they voluntarily recalled the products only to defend them. People will try mighty hard to save face, or more importantly, the faces on those green pieces of paper we all love so much.

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Hydroxycut Warning & Recall

2009-05-17T08:14:00.000-07:00

On May 1, 2009, the U.S. Food & Drug Administration (FDA) warned consumers to stop using Hydroxycut products immediately. Hydroxycut products are extremely popular weight loss and dietary supplements, accounting for nearly 90% of the weight loss supplement market. Roughly 1,000,000 Hydroxycut bottles are sold each year. The recall came as a result of 23 reports of serious health injuries and death, caused by Hydroxycut.

Hydroxycut is a weight loss supplement, which is designed to suppress appetite and burn fat. However, Hydroxycut causes serious medical problems. These problems include liver damage, seizures, cardiovascular disorders, rhambdomyolysis (muscle damage that can lead to kidney failure), jaundice and elevated liver enzymes. Other liver damage has been reported and liver transplants were necessary to correct the damage. At least one person has died from liver failure caused by Hydroxycut.

What is even more troubling than the 23 reports of injuries, are the people who are suffering these injuries. The patients affected by Hydroxycut are 21-51 years old, which is extremely young for these types of injuries. In addition, in most cases there was no pre-existing medical condition to explain the liver injuries. Further proof that Hydroxycut caused these injuries, some patients’ liver function returned after discontinuing their use of Hydroxycut. Because of these very serious injuries and deaths, Iovate Health Services, the manufacturer of Hydroxycut, voluntarily recalled some of its products.

But why the voluntarily recall? Why didn’t the FDA issue its own recall of Hydroxycut? The FDA even warned consumers “to discontinue use of Hydroxycut products in order to avoid any undue risk.” The FDA admitted it was dangerous and risky to take Hydroxycut, but the FDA failed to recall the drug. There is evidence to suggest the FDA has known about the adverse side effects of Hydroxycut since 2002 and have done nothing about it. There were no warnings made to the public about increased risk of liver damage, liver transplants or death caused by using Hydroxycut products.

According to an FDA report dated March 6, 2003, there had been 8 reports of serious injuries or death involving Hydroxycut; the earliest report dating from 1999. There were two deaths reported, in 1999 and 2001; both involved young men, age 21 and 35 years old. There were two reports of cerevbrosacular accident/stroke and cardiac injuries, involving a 16 and 26 year old. A 26-year-old woman suffered from a seizure. Three people reported psychiatric injuries, including mania, suicidal thoughts, severe psychosis, hallucinations and depression. The ages of those three victims were 17-20 years old. The report was from 2003. Who knows how many deaths and serious injuries caused by Hydroxycut, have been reported in the last 6 years?
The FDA has known about these risks and done nothing. Additional warnings about the risk of injuries are necessary to protect the public. Why wait seven years to warn the public about Hydroxycut? The FDA waited too long to warn the public and people suffered as a result. The FDA needs to do its job in protecting the health and safety of the American public.

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How Safe Are Class One Devices?

2009-04-20T09:09:00.000-07:00

The U.S. Food & Drug Administration (FDA) has a system of classifying products and drugs based on perceived risk. Class One devices are devices that are considered to be low risk to users. However, denture cream, a Class One device, has been found to be dangerous and of high risk to users.

Denture creams or denture adhesives are used to adhere dentures to gums. Denture cream is meant to be used once a day. However, because of poor fitting dentures, some people use denture cream more than once a day. They are not aware how dangerous excessive use of denture cream can be. Zinc, is a key ingredient in most denture creams. As a Class One device, the FDA does not require any ingredients to be listed on the denture cream label. In addition, there are no posted warnings on the denture cream label or packing. As a result, users are unaware of the high zinc content in denture cream. Use of denture cream can actually lead to zinc poisoning and copper deficiency in the body. Denture cream users absorb the zinc through their gums.

Zinc poisoning cause neuropathy and other neurological damages. Symptoms of neuropathy include unexplained weakness, numbness, loss of sensation and pain. Some patients even suffer paralysis. Zinc poisoning is extremely serious. Even with treatment, some of the symptoms are irreversible. Patients may suffer permanently from neuropathy, just because they wear dentures. Because of the lack of warnings and labels, doctors are often unaware of the risk of zinc poisoning in patients who wear dentures. Doctors often misdiagnosis patients with other diseases, meaning patient continue to use denture cream and continue to poison themselves.

The serious link between denture cream and zinc poisoning was recently discovered in studies performed by doctors and researchers. Such studies are very important as roughly 35 million American wear dentures. A majority of users are elderly and therefore more vulnerable to zinc poisoning. The elderly are also more vulnerable to misdiagnose of zinc poisoning because they are likely to be suffering from other medical problems.

The FDA needs to be more upfront with the public about Class One Devices. Clearly there are serious issues with denture cream. The FDA approved denture creams as a Class One Device over thirty years ago. Thirty years ago! It seems like the FDA should have re-examined denture creams in the last thirty years to determine if they were still “low-risk.” Hopefully the FDA would consider zinc poisoning and irreversible neuropathy something more than “low risk.” But what is even worse, are there other unsafe devices that we don’t even know about yet? Why cannot the FDA list the ingredients and provide warnings for all products? The public has a right to know is what they are using is harmful. We should not have to wait to discover a simple product like denture cream causes permanent neurological damage. Simple warnings about excessive use and the listing of zinc as a key ingredient in denture cream, could have avoided many of these problems.

Celexa: Lawsuits and Investigations Against Celexa’s Manufacturer

2009-04-14T11:30:00.000-07:00

Forest Laboratories manufactures an antidepressant drug citalopram under the brand name Celexa. Celexa is designed to treat depression and other mood disorders. The U.S. Food & Drug Administration (FDA) approved Celexa for use in adults. However, it is not approved for use in children and teens. Forest Laboratories has been illegally marketing Celexa for children. In addition, it has offered doctors bribes and other kickbacks to prescribe Celexa for children and teens. Forest Laboratories also concealed a study about the negative effects of Celexa on children and teens.

For these actions, the U.S. Department of Justice (DOJ) is investigating Forest Laboratories. Forest Laboratories is being charged with fraud and for violating the False Claims Act. The fraud and false claims charges stem from their concealment of the negative Celexa study. The study found that Celexa was actually ineffective in treating children and teens for depression. What is even worse, the study showed that Celexa actually INCREASED the risk of suicidal thoughts and behavior in children and teens.

Even knowing about the study, Forest Laboratories still encouraged “off label” use of Celexa. “Off-label” use means illegally marketing drugs for uses, which they are not approved for. Doctors prescribed Celexa for children, which cost government health plans such as Medicare and Medicaid thousands of dollars. The DOJ is seeking to recover the money the government programs spent on Celexa, times three, to account for the total damages to the government. Forest Laboratories may be liable for millions of dollars of damages. Each violation can be a civil penalty of $11,000.

Federal prosecutors are also investigating the kickbacks Forest Laboratories gave to doctors to encourage Celexa prescription. Such kickbacks included baseball tickets, paid vacations and gift certificates. Forest Laboratories also ran “seeding studies,” which are marketing efforts to promote Celexa’s use by doctors. Ironically, doctors are allowed to prescribe drugs to children, even if the federal government does not approve them. Doctors were allowed to prescribe Celexa to children, but it was illegal for Forest Laboratories to actively market and encourage doctors to make such prescriptions.

Forest Laboratories’ behavior only gets worse. Instead of disclosing the negative results of the study, Forest financed its own study for Celexa. This study found Celexa was effective. Forest Laboratories then used the positive study to market Celexa. Motivated by greed and profit, Forest Laboratories put children’s lives at risk. Forest Laboratories knew Celexa was dangerous for children and teens and then did nothing. In fact, they took deliberate steps to conceal the danger and manufactured a study to say Celexa was safe and effective.

Forest Laboratories was looking to protect its profit and stock prices, not the American public. Doctors, who accepted kickbacks and bribes, are just as reprehensible. They put their own patients’ lives in danger for a fancy meal and a nice vacation. Hopefully these lawsuits and investigations will be successful; Forest Laboratories will be forced to pay huge fines and doctors and top Forest Laboratories’ executives will go to prison, because they put profit before patients.

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Raptriva Update: Raptiva Withdrawn from U.S. Market

2009-04-14T11:09:00.000-07:00

On April 8, 2009, the U.S. Food & Drug Administration (FDA) announced Raptiva would be withdrawn from the U.S. market. Raptiva is an once weekly injection, designed to treat moderate to severe cases of plaque psoriasis. Raptiva was approved by the FDA in 2003, but began to have problems in 2008.

In October 2008, the FDA issued a Black Box warning for Raptiva. The new label was required to warn users of a rare disease caused by Raptiva. The disease, PML (progressive multifocal leukoencephalopathy) is a neurological disorder caused by a virus. The virus affects the central nervous system. PML is almost always fatal and there is not any treatment. Four patients suffered from PML after taking Raptiva and three died.

Because of the problems associated with Raptiva, its manufacturer, Genentech decided to voluntarily withdraw Raptiva from the U.S. Market. By June 8th 2009, Raptiva will no longer be available. Genentech sent letters to Raptiva users letting them know of the news. Genentech advised patients to seek other options to treat psoriasis.

Reglan Gets a Black Box Warning

2009-04-10T06:18:00.000-07:00

The U.S. Food & Drug Administration (FDA) recently gave a Black Box Warning the drug Reglan. This warning is needed because of the serious risks caused by Reglan.

Chronic use of Reglan causes a neurological disorder called tardive dyskinesia. This disorder is characterized by Parkinson-like symptoms. Patients suffer from repetitive and involuntary movements throughout their body. These symptoms are often irreversible. In addition, there is no treatment for tardive dyskinesia; people will suffer with these symptoms for the rest of the lives. In addition, Reglan can actually mask symptoms of tardive dyskinesia. The active drug in Reglan, metoclopramide, suppresses symptoms of tardive dyskinesia.

The FDA knows people are taking Reglan too long. Anything beyond three months is considered chronic use. The FDA knows these people are at risk for developing tardive dyskinesia. According to a study data from the FDA, over 20% of patients take Reglan for more than three months. In addition, two studies have shown that nearly 30% of patients who take Reglan for over a year develop tardive dyskinesia. These patients will constantly suffer from involuntary movements of their face, mouth, jaw, tongue, eyes, neck, shoulders, torso, larynx, diaphragm, arms, legs, feet, and hands. Clearly patients are not being made aware of the dangers of long term use. The FDA is not doing enough to warn patients about the risks of developing tardive dyskensia. In addition, the FDA has reports of people developing tardive dyskensia even though they took Reglan for less than three months.

Reglan is prescribed to treat gastroesophageal refleux, gastroesophageal relflux disease and diabetic gastroparesis. Older, female patients are at a high risk of developing tardive dyskinesia. However, children and infants have a greater risk of developing tardive dyskinesia than adults. Children and infants will also have to suffer from the symptoms of tardive dyskinesia for their entire lives.

The FDA is failing the public by not putting the Black Box Warning on Reglan sooner. The FDA also needs to make it clear that Reglan should only be used as a drug of last resort, meaning if all other treatments have failed. Because of the risk of developing an irreversible disorder, the FDA has to be better about warning the public of the dangers associated with Reglan. Patients should know the risk that taking a drug to treat acid reflux can lead to neurological disorders.

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Metoclopramide: FDA Announces Black Box Warning For Drugs Containing Metoclopramide

2009-03-11T11:48:00.000-07:00

On February 26, 2009, the U.S. Food & Drug Administration (FDA) announced it was requiring a new Black Box warning to be added to metoclopramide-containing drugs. These new warnings are required because patients are at risk for developing tardive dyskinesia as a result of using metoclopramide-containing drugs.

Metoclopramide drugs are used to treat different gastrointestinal disorders, such as gastroesophageal reflux disease and diabetic gastroparesis. Metoclopramide works by speeding up the movement of the stomach muscles. This increases the rate at which the stomach empties into the intestines. Metoclopramide-containing drugs are in many forms, injections, tablets and syrups. Some examples of metoclopramide containing drugs are Reglan Tablets, Reglan Oral Disintegrating Tablets, Reglan Injection and Metoclopramide Oral Solution.

The Black Box warning is the FDA’s strongest warning for a product. But why did it take the FDA so long to issue such a warning. Metoclopramide drugs already had a warning about developing tardive dyskinesia. The FDA should have issued the Black Box warning sooner as tardive dyskinesia is a very serious and irreversible disorder. Tardive dyskinesia is a neurological disorder in which the body has involuntary, repetitive movements of the extremities. It can also include impaired movement of fingers, rapid eye movement or blinking, puckering, pursing or smacking of lips, grimacing and tongue protrusion. Developing tardive dyskinesia is directly related to the length of time patients take metoclopramide-containing drugs and the dosages they take. The people at greatest risk for developing tardive dyskinesia are the elderly and people who have taken it for a long time.

The symptoms associated with tardive dyskinesia are usually irreversible. A few patients have had fewer symptoms after they stopped taking metoclopramide-containing drugs. However, most patients will always suffer from these symptoms. In addition, there is no known treatment for such symptoms once patients develop them.

Along with the Black Box Warning, manufacturers of metoclopramide drugs are also required to have a Risk Evaluation and Mitigation Strategy (REMS) and provide patients with a medication guide telling them of the risks. Metoclopramide drugs are only meant to be short-term treatment. Patients should not take these drugs for longer than 3 months. However, the FDA has been aware that patients take metoclopramide drugs for much longer. According to FDA study data, roughly 20% of patients use metoclopramide drugs for longer than 3 months. If the FDA knew about these risks, why not tell the patients. Only now is the Director of the FDA’s Center for Drug Evaluation & Research warning “the chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.”

The new Black Box Warning will hopefully prevent future patients was developing tardive dyskinesia. But it is likely little comfort to patients who have already have this serious and irreversible disorder. A disorder caused by a drug that the FDA approved.

Raptiva Update

2009-02-25T09:55:00.000-08:00

The U.S. Food & Drug Administration (FDA) initially issued a warning for Raptiva in October 2008. Raptiva is taken by patients to help with psoriasis. A black box warning was added to Raptiva’s labeling and Raptiva’s manufacturer, Genentech, was required to develop a risk evaluation and mitigation system for Raptiva. All of these warnings were necessary because some patients taking Raptiva were developing a rare brain infection known as Progressive Multifocal Leukoencephalopathy (PML).

Unfortunately, additional cases of PML have been reported since the FDA’s last warnings. There have been three confirmed cases of PML since last October and one more potential PML case. As a result the FDA has issued a Public Health Advisory to notify healthcare professionals of these new developments. The dangers of taking Raptiva continue to be confirmed by the FDA, yet the FDA still has not issued a recall for Raptiva.

FDA Warnings for OSP Products Come Too Late

2009-02-09T10:28:00.000-08:00

On December 11, 2008, the U.S. Food & Drug Administration (FDA) issued a black box warning for OSP products. OSP (oral sodium phosphate) products are used to cleanse the bowel and intestines before a colonoscopy and other medical procedures. The FDA warned against taking over the counter OSP products, such as Fleet Bowel Prep and Fleet Phospho-soda. The FDA also placed black box warnings on prescription OSP products such as Visicol and OsmoPrep.

However, these warnings come too late. The FDA has known since 2006, nearly three years ago, about the risks associated with OSP. In March 2006, the FDA released an alert about OSP products and acute phosphate nephropathy, which is a type of renal (kidney) failure. At the time of the alert, there were 21 cases of acute phosphate nephropathy, caused by use of OSP products. Of the 21 cases, 17 had chronic renal (kidney failure). Acute renal failure is very serious and can lead to other problems. People have a greater risk of developing problems with heart disease and infections. In additional, treatment for acute renal failure can include dialysis or even a kidney transplant. Since 2006, the FDA has received reports of additional cases of acute phosphate nephropathy caused by OSP products.

What’s more, the FDA finally issued warnings after a petition was filed asking for such black box warnings. The petition was filed on September 20, 2007. It took until December 11, 2008 for the FDA to response and grant the petition. This is not the first petition the FDA has received about OSP products. In August 2000, over eight years ago, Braintree Laboratories, issued a petition. In it, they asked that OSP products be made prescription only, not to allow over the counter products. In addition, Braintree Laboratories asked for a boxed warning on the label of the OSP products to warn users of the serious problems associated with OSP. The FDA denied their petition in 2001. The FDA claimed it did not have sufficient evidence to make a determination. The FDA argued the cause of the adverse events was because physicians failed to properly explain to patients how to use the product.

As a result of the warnings, C.B. Fleet Company, the manufacturer of Fleet Bowel Prep an Fleet Phospho-soda issued a voluntary recall of its over the counter OSP products. However, why didn’t the FDA take action faster? The FDA has known about the problems caused by OSP products since at least 2000, if not before. However, only after repeated petitions and reports of acute renal (kidney) failure did the FDA finally respond by issuing black box warnings. These warnings came eight years too late. During those eight years, more people have taken OSP products and suffered. Who knows how many people would not have suffered if the FDA had taken action sooner?

FDA is now requiring warnings to be placed on anti-seizure medications

2009-01-21T08:14:00.000-08:00

The U.S. Food & Drug Administration (FDA) is now requiring warnings to be placed on anti-seizure medications. Lyrica, along with 22 other antiepileptic medications have to add warnings about the risk of suicidal thoughts and behavior. The FDA has known since January 2008 about the increased risk of suicidal thoughts and behavior, yet it took them until December 16, 2008 to require the warnings to be added.

Lyrica is used to treat psychiatric disorders, migraine headaches, nerve pain from shingles, diabetic nerve pain and epilepsy. The FDA approved Lyrica in December 2004. Along with the new required warnings, Lyrica must also provide a Medication Guide to patients taking Lyrica and a Risk Evaluation and Mitigation Strategy from its manufacturers. The FDA has spent the entire year of 2008 deciding what to do about Lyrica.

In January 2008, the FDA warned health care professionals about the increased risk of suicidal thoughts and behavior associated with Lyrica. In reviewing 199 clinical trials of Lyrica and ten other antiepileptic medications, the increased risk was discovered. The clinical trials compared people taking antiepileptic medication and people taking a placebo. The people taking the real medication had nearly double the risk of suicidal thoughts and behavior. This translates to one additional person per every 500 cases having suicidal thoughts and behavior. In addition to the increased risk of suicidal thoughts and behavior, the increased risk can occur at any time. The increased risk has been shown only one week after patients started taking the antiepileptic drugs and continues for their entire treatment.

It took the FDA until July 2008 to convene a public meeting to discuss the increased risk of suicidal thoughts and behavior for patients taking Lyrica and other drugs. Although acknowledging the increased risk to patients, the advisors at the meeting did not give Lyrica and other drugs a Black Box warning. A Black Box Warning is strongest warning given by the FDA. It means significant risk of adverse side effects including death. Instead the advisory panel experts recommended a lower warning, which the FDA did follow.

The lesser warning is now required for twenty-three drugs, in total, including Lyrica. Nevertheless, based on the information, it seems like a stronger warning is needed. Increased risk of suicidal thoughts and behavior is very serious and life threatening. The FDA should require a Black Box warning. In addition, it should not have taken a year for the FDA to issue a warning once they knew about the increased risk. Why did they wait so long?

All 23 of these listed drugs are required to have the new warning:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal)
Phenytoin (marketed as Dilantin)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Rufinamide (marketed as Banzel)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Valproic Acid (marketed as Depakene, Stavor Extended Release Tablets)
Zonisamide (marketed as Zonegran)

Double Trouble: Double Dosage Discovered in Five Drugs

2008-12-12T07:18:00.000-08:00

The Ethex Corporation issued a voluntary recall of five generic drugs on November 7, 2008. The reason behind the recall was simple, manufacturer error. All five drugs were voluntarily recalled because of oversized tablets. Oversized tablets means the active ingredient contained within the drugs was twice the normal dosage. But how could this happen? This mistake was made multiple times. Not once, not twice, not even three times, but FIVE times, meaning FIVE drugs contained double the dosage, which was harmful to patients.

Ethex Corporation and the U.S. Food & Drug Administration (FDA) issued the voluntary recall for five different drugs: Propafenone HCI Tablets, Isosorbide Monoitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate Tablets. All of these drugs have different purposes and it can be very dangerous to receive a double dosage.

Isosorbide Monoitrate is used to prevent or reduce angina in patients with coronary artery disease. It works by dilating the blood vessels to allow more blood to flow to the heart. The drug is designed to make it easier for the heart to work and increase the blood flow and oxygen supply to the heart. However, an overdose of Isosorbide Monoitrate can cause fainting and low blood pressure.

Propafenone HCI is used to treat illnesses which have irregular heartbeats, known as arrhythmias. It is designed to prevent arrhythmias from occurring. However, an overdose can actually leads to low blood pressure and arrhythmias. Morphine Sulfate is drug used to help patients with pain, especially patients with chronic or severe pain. A double dosage of either type of morphine sulfate results in low blood pressure and respiratory depression (hyperventilation, meaning, difficulty or lack of breathing).

Dextroamphetamine Sulfate is used to lessen appetite and fatigue. It is used to treat narcolepsy (sleep attacks) and ADHD (attention deficit hyperactivity disorder). If patients receive a double dosage, they can experience high blood pressure and rapid heart rates. Any of these side effects caused by the double dosage can be serious and life threatening for patients.

The recalled drugs were all shipped before May 22, 2008 and had expiration dates ranging from November 2008-May 2011. It is important for patients to be aware of these problems before it’s too late. The list of recalled lots is located on the U.S. FDA website.

The double dosage of five separate drugs brings up many questions. How are these drugs manufactured? Why aren’t there protocols in place to prevent this from happening? Where does Ethex Corporation manufacture its drugs? Did the botched drugs come from China? Manufacturing defects in China are to blame for the contamination of Heparin. Did manufacturing error cause the double dosages with these five drugs? Currently, these are all unanswered questions.

But one thing is clear. The FDA is not doing enough to protect consumers. People with serious medical conditions take all of these drugs. Any problems with their medication could seriously jeopardize their health. The FDA needs to have more safety regulations in place to make sure double dosages do not happen again. This may be little comfort to the people already affected by these five drugs. It may, however, protect other patients in the future.

Digitek's Double Dosage: One of many mishaps by Actavis

2008-12-05T12:13:00.000-08:00

On April 25, 2008, the U.S. Food & Drug Administration (FDA) issued a Class I Recall of all Bertek & UDL Laboratories Digitek (digoxin tablets, USP). The recall included all strengths of Digitek. Class I recalls are conducted when dangerous or defective products that predictably could cause serious health problems or death are released. Digitek was recalled because of a serious manufacturing defect, the tablets contained double the dosage of the active ingredient.

Digitek is used to treat abnormal heart rhythms and heart failure. With the double strength tablets there is a risk of digitalis toxicity. Digitalis toxicity is extremely dangerous. It can result in cardiac instability and bradycardia (low heart rate). The double dosage has lead to severe injuries and even deaths. Digitek was used to treat both humans and animals. In May 2008, the FDA also warned veterinarians about the possibility of double dosage tablets and adverse drug reactions in animals. Digitek can be life threatening for animals too.

Actavis Group is the manufacturer of Digitek tablets, while Mylan Pharmaceuticals and UDL Laboratories distributed the recalled Digitek. Actavis has already been sued for toxic overdoses by Digitek patients. In the lawsuits, it is alleged, when the FDA inspected an Actavis plant, they found problems. Actavis was not following the Good Manufacturing practices, required by the FDA. The departure from these standards, contributed to the manufacturing defects of the drug. The lawsuits are just the start of Actavis’ problems.

On October 8, 2008, the U.S. House of Representatives, specifically the Committee on Energy & Commerce, wrote a letter to the FDA about Actavis. The Committee is “investigating the ability and commitment of the Food and Drug Administration to protect Americans from unsafe food and drugs.” Specifically the Committee expressed concerns about Actavis because of the Digitek recall and another recall they experienced in August 2008. On August 1, 2008, Actavis’s Little Falls, New Jersey plant recalled all products produced from the plant. It was a total of 66 products. The recall was voluntary but came as a result of an inspection done by the FDA in earlier 2008. During the inspection, the FDA found Actavis was not meeting good manufacturing practice standards. This was actually the company’s third recall in 2008.

The first recall occurred on February 8, 2008. Actavis South Atlantic, which is a subsidiary of Actavis, recalled Fentanyl transdermal patches because of a manufacturing defect. These patches contain strong narcotic drugs used to treat patients’ with chronic pain. The drugs from the patch are absorbed through the skin. The patches were recalled because of a potential defect, the gel in the patched leaked. This is extremely dangerous because the mere contact between the gel and skin can cause respiratory depression and death. Fourteen lots of the Fentanyl transdermal patches were recalled in February, twelve more lots were recalled in March.

Combined, all of these recalls, have raised concerns with Congress. They “question whether [the] FDA was deceived regarding the current good manufacturing practices (cGMPs) of this company, or did [the] FDA simply fail to conduct adequate and timely inspections of these facilities.” The committee requested numerous documents from the FDA regarding inspection reports, observations and testing of Actavis drugs. The yet unresolved question is whether the FDA should have known about manufacturing defects when it continued to allow Actavis products to still be marketed and distributed. The bottom line is, Actavis has major manufacturing problems, which has led to three separate recalls in 2008. Both Actavis and the FDA needs to make sure drugs are not defectively manufactured or else we will have even more recalls, serious injuries and deaths from these drugs.

Pain Pumps: More Than You Bargained For

2008-11-17T13:22:00.000-08:00

Pain pumps are a newer method of administering and managing pain. Pain pumps are implemented during surgery. Following the surgery, patients use the pump to administer drugs and medication to help them with the pain. However, the pain pump can cause serious problems. Use of the pain pump can lead to Post-Arthroscopic Glenohumeral Chondrolysis (PAGCL). PAGCL occurs because the pain pump has deteriorated the cartilage in the shoulder. This can lead to permanent damage.

Pain pumps are meant to help, not harm patients. The pump is inserted into the shoulder joint during the shoulder surgery. The pump then delivers drugs to the bloodstream through a catheter. The pumps are only temporary and are removed within two days following surgery. However, to alleviate temporary pain, patients have to risk PAGCL, a permanent condition. PAGCL is very painful and currently there is no effective treatment. Most people with PAGCL end up having shoulder replacement surgery.

According to the American Journal of Sports Medicine study there is a very high correlation between intra-articular (between joints) pain pump catheter and development of PAGCL. About 63% of patients who had intra-articular pain pump catheters developed PAGCL. What’s even worse about PAGCL is how it develops. Initially, patients make progress after their surgery. They are able to participate in physical therapy and get some motion back in their shoulder. But then the PAGCL sets in. Patients experience the onset of new “pain, stiffness, increased pain with motion, and crepitus [popping of joints].” This can occur anytime from 3-12 months after surgery.

Dealing with PAGCL is not easy. Over 83% of patients had to have additional surgeries following their diagnosis of PAGCL. Even the additional surgeries are not completely helpful. All of the patients continued to experience pain and some disability. Some patients will never fully regain motion in their shoulder. This is even more alarming, when you consider the average age for these types of surgeries 28-29 years old. They will have to deal with this painful condition and loss of mobility for years to come.

The study found there is a “concerning and strong association between postarthroscopic chondrolysis [PAGCL] and intra-articular pain pump catheter use.” In addition, there is still no treatment for PAGCL. More investigation needs to be done to find an effective treatment for PAGCL. People need to seriously think about the risks before using a pain pump. Temporary help with pain following surgery is not worth permanent shoulder damage. People need to know that with pain pumps, they will get more than they bargained for.

FDA Adds Black Box Warning to Raptiva

2008-11-10T09:07:00.000-08:00

Raptiva is getting the highest warning possible by the U.S. Food & Drug Administration (FDA). A black box warning is the strongest warning the FDA will give a drug. It means that medical studies have indicated Raptiva has a significant risk of adverse side effects including death. The warnings were added because of life-threatening infections caused by Raptiva.

Raptiva is a weekly injection used to treat plaque psoriasis. Psoriasis is a disorder affecting joints and skin. It is a chronic condition and its cause is unknown. Psoriasis causes skin inflammation and scaly skin patches. Plaque psoriasis is the most common type of psoriasis, accounting for 80-90% of cases. Psoriasis can be mild to severe. Raptiva is designed to treat severe psoriasis. Raptiva works by suppressing the immune system to prevent inflammation of the skin. However, it also “suppress [es] the body’s natural defense system.” Without the body’s defense system, there is a serious risk patients using Raptiva will contract life-threatening infections. Click here to read entire story.

Patients can be infected with bacterial sepsis (affects the body’s organs), viral meningitis (brain infection), invasive fungal disease (fungal infection throughout body) and PML (progressive multifocal leukoencephalopathy), which is a brain infection resulting in disability or death. Because of these risks, the FDA updated the label warnings on Raptiva. In addition to the warnings about infections, the new labels will also discuss animal studies of Raptiva. Studies completed on young mice have show there is a risk of permanently suppressing the immune system because of Raptiva. The young mice are equivalent in age to humans under the age of 14. Although the FDA did not approve Raptiva for adults under the age of 18, the fact remains is Raptiva safe for adults to use? Permanent suppression of the immune system is very serious because it helps the body fight infections and diseases.

This is not the first warning added to Raptiva. In July 2005, Genentech, Raptiva’s manufacturer, added safety information on the label. The new warnings included risk of hemolytic anemia, which means the body does not have sufficient red blood cells because they have been destroyed. The warnings also warned about necrotizing fasciitis (fleshing eating bacteria), tuberculous pneumonia, bacterial sepsis (blood poisoning), severe pneumonia with neutropenia (low white blood cell count) and worsening of infections.

Even with all of these problems, the FDA has not recalled Raptiva. FDA merely cautions, “doctors and other prescribers [to] carefully evaluate and weigh the risk/benefit profile of Raptiva.” Raptiva may help people suffering from servere psoriasis, but at what cost? There are other drugs available for psoriasis that do not cause serious infections and death. The FDA should advise consumers to stop using Raptiva before more people die.

Contamination in Manufacturing Heparin

2008-11-10T08:56:00.000-08:00

Most people would agree that pharmaceuticals provide some benefit to their users. However, the best-developed drug can still harm consumers when it is defectively manufactured. Heparin, a blood thinner, has had manufacturing defects in the past year, which have seriously injured and killed consumers. Poor oversight, faulty inspections and international production of this drug have all contributed to this horrific problem.

In February 2008, Baxter Healthcare Corporation, one of Heparin’s manufacturers, voluntarily stopped production of Heparin. Baxter agreed to stop producing the multiple and single dose vials of Heparin and the HEP-LOCK heparin flush products, due to Heparin contamination. Heparin is used to prevent blood clots, deep vein thrombosis and pulmonary emboli in patients undergoing kidney dialysis and heart surgery. Click here to read entire story.

Baxter stopped producing Heparin because of the adverse reactions that were reported by users. The U.S. Food & Drug Administration (FDA) received 785 reports of serious injury due to Heparin. Forty-six deaths have been reported, of that, 19 are thought to be caused by Heparin. Many of the reports included hypotension and allergic reactions because of Heparin.

The root cause of all these problems was due to Heparin contamination. The contamination began in China, which is the main supplier of the raw ingredients used in Heparin. The raw materials for Heparin come from the intestinal tissue of pigs. Chinese pigs are used because China is the world’s leading pig producer. In the past year, the Chinese pig population suffered from a virus, which resulted in many sick pigs. This created a shortage of raw ingredients. The contaminant found in the Heparin was oversulfated chondrotin sulfate. It is synthetic and mimics raw heparin. Only high-tech tests, like magnetic resonance imaging, can distinguish between the raw heparin and the contaminant. Oversulfated chondrotin sulfate is readily available and fairly inexpensive. It is believed all these factors made chondrotin an appealing option to use due to the heparin shortage. However, it was the oversulfated chondrotin sulfate that led to the contamination. Rather than stopping or decreasing production, a dangerous substitute was used. This dangerous substitute caused serious injury and death to consumers.

Changzhou SPL Company, based in China, purchased contaminated raw materials, which were then sold to Scientific Protein Laboratories. Scientific Protein Laboratories supplies companies like Baxter International, with ingredients to make the final product, Heparin. The FDA is also to blame for the Heparin contamination. The FDA failed to follow its own guidelines and procedures when it approved Changzhou SPL’s plant without inspecting it. Members of the FDA did not inspect the plant until February 2008. In addition, Changzhou SPL did not have an operating license or any regulatory oversight by the FDA or the Chinese authorities until February 2008, which was another violation of the FDA procedure. Following the FDA’s inspection of Changzhou SPL, it issued a warning letter about deficiencies at the plant. In the letter, the FDA cited many problems, including the failure to have a system to evaluate the raw materials used to make Heparin.

Although the FDA has now introduced new instructions and screening methods for testing drugs, the question remains whether this will help with manufacturing defects and contamination. Over one-half of U.S. Heparin products receive their raw ingredients from China. China is the largest supplier of pharmaceutical ingredients and as of March 2008, the FDA had only inspected 64 of roughly 700 medical device plants in China. The FDA must do more to prevent further contamination. The FDA must follow its own procedures and inspect the plants where consumer goods are produced. Consumers cannot afford for the FDA to be complacent in their responsibility to the public, or future contamination is inevitable.

Byetta Warnings: Too Little, Too Late

2008-10-31T11:30:00.000-07:00

On August 18, 2008, the U.S. Food & Drug Administration (FDA) announced plans to strengthen the warning labels on Byetta. Byetta is a medication designed to control blood sugar in adults with type II diabetes. It is administered by injection, twice daily. New warnings were needed because of six hospitalizations and two deaths of Byetta users. These deaths were caused by hemorrhagic or necrotizing pancreatitis. The warning came too late. The FDA knew there were problems with Byetta, almost a year earlier. Click here to read entire story.

In October 2007, a Health Alert was issued by the FDA, due to the report of 30 cases of acute pancreatitis (sudden inflammation of the pancreas). Twenty-one of those patients were hospitalized, of that five had serious complications. In addition, the condition of twenty-two patients improved after they stopped taking Byetta. Because of this, the FDA asked Byetta’s manufacturer, Amylin Pharmaceuticals to add new warnings to Byetta. Amylin agreed to add information about acute pancreatitis in the PRECAUTION section of the label. It has been alleged Amylin never followed through on their promise to add the 2007 warning. If this is true, the FDA never fulfilled their promise to the public.

Byetta has dangerous side effects. Since the Health Alert in October 2007, the FDA has received reports of six cases of hemorrhagic pancreatitis (inflammation of the pancreas which leads to bleeding) or necrotizing pancreatitis (the inflamed pancreas destroys itself) in patients using Byetta. Six patients had to be hospitalized and two subsequently died. This recent report prompted the FDA to again ask Amylin Pharmaceuticals to add warnings to Byetta. This time, the FDA wanted “stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.”

However, even this suggested warning is not strong enough. Byetta has been shown to cause death and serious injury. The public has a right to be warned about death or serious injury if they take Byetta. Byetta is a hugely popular diabetes drug because of the weight loss most users experience while on Byetta. More than 700,000 people have taken Byetta since June 2005. Byetta is not the only drug available to help control blood sugar for diabetics. The FDA approved it only three years ago. In that short time, two warnings have been issued. The public cannot wait for the FDA to decide how many more people have to die or be seriously injured before appropriate action is taken.

Merck & Company: When Profits Motivate Action

2008-10-10T08:57:00.000-07:00

Merck & Company, the manufacturer of the human papilloma virus (HPV) vaccine, Gardasil, has grossed huge profits since the U.S. Food & Drug Administration (FDA) approved Gardasil in 2006. In 2006, Merck’s revenues were $22.6 billion dollars. In 2007, the Boston Globe estimated Merck could make $3 billion a year, just from Gardasil alone. Merck makes so much profit because of Gardasil’s expense and Merck’s attempts to make Gardasil mandatory. The Gardasil vaccine is given in stages; the three injections total $360.00. This number may look small at first glance, but it’s not. John Schiller, an investigator at the National Cancer Institute, stated Gardasil “will be more expensive than all other childhood vaccines put together.”

Although Merck obviously believes in the benefits of its vaccine, it did not try to make Gardasil more affordable. Instead, Merck & Company launched an aggressive lobbying campaign at the states to make Gardasil a mandatory vaccine. Merck pushed states to make Gardasil mandatory for sixth grade girls. In overwhelming numbers, the states responded. According to the National Conference of State Legislatures, 24 states and the District of Columbia (DC) introduced legislation to mandate the HPV vaccine for girls. Unfortunately, Merck was able to achieve some success.

In February 2007, the governor of Texas issued an executive order mandating all sixth grade girls receive the HPV vaccine. Luckily, the Texas legislature voted to override the governor’s order. In Virginia, the state legislature passed a law requiring Gardasil for school age girls to begin in 2008. This has been delayed until 2009. However, Merck was not deterred and continued to lobby states to make Gardasil mandatory. Such action was not only appalling but also irresponsible. The long-term implications of Gardasil on women’s fertility have not been studied. Thousands of reports have been made to the FDA about the dangers associated with Gardasil including blood clots, seizures and spontaneous abortions. Merck is promoting an unsafe product and trying to make sure as many people as possible are vaccinated.

Finally, in response to public pressure, Merck & Company decided to cease its lobbying efforts. However, this does not excuse their past actions. Merck was motivated by money; the more people who received the Gardasil vaccine, the more money they made. Gardasil is currently the only HPV vaccine available on the market, meaning any law mandating the HPV vaccine, refers to Gardasil. It is Merck & Company, not the people who receive the vaccine, who benefit from Gardasil.

Gardasil: Problems of the FDA Fast Track

2008-10-06T09:18:00.000-07:00

The U.S. Food & Drug Administration (FDA) approved the human papilloma virus (HPV) vaccine, Gardasil, in June 2006. This approval was the result of a fast track process, which totaled six months of review. The typical approval process is at least ten months in duration. The FDA’s reasoning for the quick approval was its commitment to make vaccines available as soon as possible. However, the FDA’s quick approval comes at a price. According to Judicial Watch, a public interest group, the FDA’s final testing of Gardasil will not be completed until September 2009. This means Gardasil will be on the market for three years before the final testing of the effects of the vaccine are complete.

Gardasil is manufactured by Merck & Company and is designed to treat four types of HPV, 6, 11, 16 and 18. However there are over 30 types of sexually transmitted HPVs, which, if untreated, can lead to cervical cancer. However, the long-term effectiveness of the vaccine is unknown. Currently the FDA recommends Gardasil for girls and women ages 9-26 years old. However, most cervical cancer patients are diagnosed in their 40s. No one is sure whether repeat vaccines will be necessary to offer women continued protection. In addition, the long-term effects of Gardasil, specifically on a woman’s fertility have not been studied. The only fertility tests completed by Merck & Company were done on rats. The tests showed the rats did not experience any adverse effects on their fertility and ability to mate. But, long-term effects on fertility were not tested and Gardasil treats human HPV only. Due to the obvious biological differences between rats and humans, the testing results are questionable.

Other problems with Gardasil have since come to light. It is a preventive vaccine only. Gardasil cannot help women already exposed to the HPV. Huge numbers of women are suffering because of Gardasil. According to Judicial Watch, the FDA has received almost 9,000 reports of adverse effects resulting from Gardasil. Serious medical conditions, such as, seizures, miscarriages, spontaneous abortions and Guillian-Barre Syndrome (a disease which affects the nervous system, leading to paralysis and is life-threatening) have been reported. Eighteen deaths have also been reported; the youngest was an 11-year-old girl; she died from anaphylactic shock. Another girl, who was only 12 years old, died in her sleep three weeks after receiving the vaccine. In their quest to fast track Gardasil, the FDA failed to protect the public’s welfare. Merck & Company has also failed the public. It launched an aggressive campaign to encourage states to make Gardasil a mandatory vaccine for young girls until it met with resistance from the public. However, the fact remains, Merck & Company was pushing for Gardasil to become mandatory when the vaccine is still in testing stage. In their attempt to make a profit, Merck & Company is putting women’s lives at risk. For more information about the facts and dangers associated with Gardasil, please check out our website at: http://www.good-legal-advice.com/gardasil.htm.

What’s the Deal with Levaquin?

2008-09-26T10:40:00.000-07:00

The Food & Drug Administration (FDA) has failed to do its job. The FDA was aware of the dangers associated with Levaquin for over 12 years and they failed to do anything about it. Levaquin, an FDA approved drug, is prescribed to treat bacterial infections in the lungs and sinuses. However, what the FDA failed to warn about, were the hidden dangers of Levaquin. Tendon ruptures, torn Achilles’ tendons and tendonitis are just some of the many hidden dangers caused by Levaquin. Other, more severe hidden dangers include damage to the nervous system and organ failure.

Finally, on July 8, 2008, the FDA issued a black box warning for Levaquin. The black box warnings were added to inform the public of the increased risk of tendonitis and tendon ruptures. Although the black box warning is the strongest warning given by the FDA; the warning was too little, too late. Public Citizen, a consumer advocacy organization, has been petitioning the FDA to issue Levaquin warnings since 1996. Public Citizen filed a second petition in 2006 in another attempt to get the FDA to comply with its responsibilities. Still the FDA did nothing. It took Public Citizen’s lawsuit against the FDA, before FDA would respond to their petition.

In the ten years between the two petitions, there were nearly 1,000 reported incidents of tendon ruptures and tendonitis. Levaquin or another fluroquinolone drugs have been thought to cause 80% of those injuries. These injuries are severe, painful and occur at any time. Tendon ruptures have been reported while patients are taking Levaquin and even months after they ceased taking Levaquin. The problems associated with Levaquin are even worse for people over the age of 60 and those who have undergone organ transplants. If the FDA had not been so slow to act, many of these current problems could have been avoided.

We have received dozens of calls from local citizens who have suffered from Levaquin. This is a widespread problem, affecting many people. The consequences of taking Levaquin are long lasting and life altering. At our firm, we hear from clients who are unable to continue daily activities they once enjoyed because of taking Levaquin. Their injuries are only made worse when they learn about the FDA’s failure to listen to hundreds of complaints about Levaquin and act accordingly. The FDA injured hundreds of people by failing to do its job and protect consumers. For more information about the facts and dangers associated with Levaquin, please check out our website.

THE FACTS ABOUT PRESCRIPTION DRUGS

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LINK BETWEEN ANTIDEPRESSANTS AND AUTISM

DePuy Hip Replacements Recalled Due to Extremely High Failure Rates

WHAT TO DO IF YOU THINK YOU HAVE RECEIVED A DePUY IMPLANT

Shocking Medical Malpractice Statistics

Labor and Delivery Errors

The statute of limitations – don’t miss the deadline

Over-The-Counter Drugs Abuse

Chronic Beryllium Disease (CBD): A Continuing Threat

Tylenol Poses Serious Risks, Including Death!

Dangerous Multaq Side Effects

Dangerous Risk of Anesthesia Revealed!

Severe Birth Defects Associated With Depakote!

FDA Waits Over Fifty Years to Pull Fatal Drug Darvon From the U.S. Market

AlloDerm: High Failure Rate And Risk Of Serious Complications

Fosamax: For Some, Additional Warnings Come Too Late

Weight Loss Products; Profits Over Safety When It Comes To Meridia

DePuy Misleads The Public, Consumers Suffer

Revealed: Actos No Safer Than Avandia

ZOCOR: Popular Cholesterol Lowering Medication Linked To Serious Muscle Injury

IUDs: Internationally Obtained, Non-FDA Approved Devices Discovered in Rhode Island

Wellbutrin: A Danger During Pregnancy

Prilosec, Nexium, and Prevacid: The Link To Bone Fractures Ignored Too Long

Brand name vs. Generic: Getting what you Pay For at the Pharmacy

Avoidable Hospital Infections: Clean Hands may Save your Life

Yaz (Yasmin): Bayer Chose Profit over Public Health

Reglan: Taking Responsibility for the Chronic Use of Reglan

Levaquin: Evidence of the FDA’s Shortcomings

Stevens-Johnson Syndrome (SJS): A Deadly Allergic Reaction

Denture Cream: Hidden Threat?

Raptiva Finally Removed From Market

Fosamax Linked to Yet Another Serious Bone Injury

Matrixx Initiatives, Inc. Reeling Over Zicam Voluntary Recall

Hydroxycut Warning & Recall

How Safe Are Class One Devices?

Celexa: Lawsuits and Investigations Against Celexa’s Manufacturer

Raptriva Update: Raptiva Withdrawn from U.S. Market

Reglan Gets a Black Box Warning

Metoclopramide: FDA Announces Black Box Warning For Drugs Containing Metoclopramide

Raptiva Update

FDA Warnings for OSP Products Come Too Late

FDA is now requiring warnings to be placed on anti-seizure medications

Double Trouble: Double Dosage Discovered in Five Drugs

Digitek's Double Dosage: One of many mishaps by Actavis

Pain Pumps: More Than You Bargained For

FDA Adds Black Box Warning to Raptiva

Contamination in Manufacturing Heparin

Byetta Warnings: Too Little, Too Late

Merck & Company: When Profits Motivate Action

Gardasil: Problems of the FDA Fast Track

What’s the Deal with Levaquin?