On November 19, 2010, the FDA sent letters to the makers of the controversial prescription painkillers Darvon, generically known as propoxyphene, and Darvocet to request that the products be voluntarily removed from the U.S. market. The request for withdrawal comes after additional data supported the conclusion that the drugs cause significant changes to the electrical activity of the heart thereby putting patients at risk for potentially fatal heart rhythm abnormalities. The new evidence confirms that the risk is present even at recommended doses. Since the release of propoxyphene under the brand name Darvon in 1954, this was the third and final push to have the drugs banned due to evidence of side-effects ranging from cardiac events to overdose.
One of the manufacturers of the drugs, Xanodyne Pharmaceuticals Inc. of Newport, Kentucky, has already agreed to remove the products stating that the “FDA has determined that the benefits of propoxyphene-containing products no longer outweigh the potential risks.”
Further, the FDA is advising doctors to stop prescribing the drug and asks patients taking it to immediately contact their physicians to discuss switching to another medication
The FDA’s determination is undoubtedly late, considering the UK pulled the drugs in 2005 due to concerns of suicide and accidental overdose and the remainder of Europe banned the drug in 2009 after the MHRA, the main drug regulatory agency of Europe, had seen sufficient evidence of the risk of fatal heart rhythm abnormalities to support the ban. The watchgroup, Public Citizen, estimates that since the UK withdrew the drugs in 2005, there have been approximately 120 million retail prescriptions filled in the U.S. for propoxyphene-containing drugs. Further still, the FDA’s request comes over a year and a half after an FDA advisory committee recommended banning propoxyphene in January 2009.
If you or a loved one have suffered a cardiac event including cardiac arrythmia, electrical disruption or death related to a cardiac event, please contact Pogust Braslow & Millrood for a free consultation.