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.
Bloomberg Businessweek reports that 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 FDA also asked 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, according to Bloomberg’s press release.
The news source goes on to explain that last year the FDA allegedly “rejected an advisory panel’s recommendation to withdraw propoxyphene after reports of fatal overdoses.” Bloomberg reports that the agency instead required a new safety study and “black-box warning label” about the dangers of excessive use. Bloomberg explains that John Jenkins, director of the FDA’s Office of New Drugs, concluded that the active ingredient’s benefits “no longer outweigh its risks.”
Bloomberg goes on to 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.
Bloomberg further explains that the director of the FDA’s Office of Surveillance and Epidemiology, Gerald Dal Pan, said in a conference call that approximately 10 million U.S. patients “received prescriptions for propoxyphene-containing products in 2009.”
Cnn reports “the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities.”
In a statement Dal Pan made, he explained that “For the first time, we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” Bloomberg reports.
If you or a loved one has experienced a serious side effect or symptoms of side effects related to Darvon or Darvocet, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication recalls. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.
References:
Kavanagh, Jim and CNN Wire Staff. (November 19, 2010) “Darvon, Darvocet to be pulled from U.S. Market.” Retrieved on November 19, 2010 from CNN.com.
Peterson, Molly. (November 19, 2010) “Darvon, Darvocet Withdrawn in U.S. Over Heart Risks.” Retrieved on November 19, 2010 from Bloomberg L.P.