After numerous requests from the Food and Drug Administration (“FDA”), Xanodyne Pharmaceuticals agreed to recall Darvocet and Darvon, which are two branded versions of propoxyphene from the U.S, market. The FDA issued this request due to the drugs (Darvon and Darvocet) allegedly putting patients at risk for the possibility of heart failure and death. The FDA concluded that in its clinical research, the dangers of Darvon and Darvocet outweighed the benefits.

Since 1978, the FDA received two requests to recall Darvon and Darvocet. In the summer of 2009, the FDA required that propoxyphene packaging contain a new warning. The warning notified patients and doctors of the numerous risks and possible fatal outcome of the drug. Xanodyne was also ordered by the FDA to perform a new safety study which paid close attention to the cardiac side effects of propoxyphene.

There has allegedly been much back and forth between the manufacturer (Xanodyne Pharmaceuticals) and the FDA. The FDA previously believed that the boxed warning label was an “acceptable” option when used at recommended doses. The FDA also required Xanodyne to conduct a new safety study and that those results are what led to the nationwide recall.

The FDA made it clear that painkillers Darvon and Darvocet should be recalled from the market due to harmful affects on patients; Xanodyne has already said it will comply.

The FDA requested that makers of the generic drugs pull their versions, too. According to the Wall Street Journal, in 2007, there were 20 million prescriptions written for the two drugs.

Darvon has been controversial for years. Public Citizen called propoxyphene a “deadly but barely effective painkiller.”? Some say that this most recent recall came too late, and that many lives could have been saved if the recall came earlier. In 2005, there were concerns that the drug was too easy to overdose on and some would label it addictive.

If you or a loved one have taken propoxyphene (Darvon/ Darvocet) and feel you may have suffered from the harmful effects you may be entitled to compensation. Do not delay, contact Consumer Injury Lawyers today for your free and confidential case evaluation.

Published November 17, 2011 by