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 12th 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.
