Darvon and Darvocet Removed by Order of FDA

CNN reports that The U.S. Food and Drug Administration asked Xanodyne Pharmaceuticals Inc. to withdraw its pain medications, Darvon and Darvocet. The manufacturer has agreed to pull both of these pain medications from the U.S. market, according to CNN. Further, the FDA also asked the eight manufacturers of generic versions of Darvon and Darvocet to remove their drugs as well. The active ingredient of Darvon, propoxyphene, was approved for the treatment of mild to moderate pain in 1957.

The withdrawal of Darvon and Darvocet was prompted by the results of a recent study that found these medications can allegedly produce “potentially fatal heart risks” in healthy individuals, even at the recommended dosages.

The Washington Post reports:

Consumer advocates welcomed the announcement, but sharply criticized the agency for failing to take action sooner. Britain pulled the drug six years ago and the rest of Europe removed it more than a year ago, they noted.

About 120 million prescriptions have been filled for the drug in the United States since Britain removed the drug, said Sidney Wolfe of Public Citizen’s Health Research Group, which has long called for the drug’s removal.

Wolfe went on to admit, “Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since the time the UK ban was announced,” Wolfe said in a statement. He called the FDA’s failure to act sooner a “serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller.”

Bloomberg  report that Xanodyne produced a statement today explaining this withdrawal is “market-wide,” and applies to all products containing propoxyphene. The company then recommended patients using these products “consult their physicians for instructions on how to safely transition to appropriate alternatives,” according to the news source.

Approximately 10 million U.S. patients received prescriptions for propoxphene-containing products in 2009.

If you or a loved one has taken this pain killer since January 1, 2006 and experienced a serious side effect or symptoms of side effects related to Darvon or Darvocet, contact Nurenberg Paris for a free consultation.  Our team of attorneys has experience specific to complications associated with prescriptions medication recalls.