Manufacturer Pulls Darvon, Darvocet from the Market; FDA Wants Makers of the Generic Form to Do the Same
Painkillers Found to Be Toxic to Heart and Produce Deadly Heart Rhythm Irregularities
The U.S. Food and Drug Administration announced on November 2010 that it is pulling off the prescription painkillers Darvon and Darvocet, which combines Darvon with acetaminophen, off the U.S. market because of new scientific evidence showing that, even at recommended doses, they can damage the heart or cause fatal cardiac abnormalities.
The manufacturer, Xanodyne Pharmaceuticals Inc. of Newport, Ky., agreed to withdraw the two brand-name drugs. The agency now is asking manufacturers of generic propoxyphene to do the same. Darvon was developed by Eli Lilly and Co. and received FDA approval in 1957 and has been a controlled drug since 1976.
Propoxyphene (PPX)-containing drugs have been banned in Great Britain since 2005. The European Medicines Agency in June 2009 recommended their gradual removal from the European Union market after concluding risks, including the risk of fatal overdose, outweighed pain-relieving benefits of these drugs.
The FDA announcement was based on a clinical trial in which electrocardiograms demonstrated that these drugs altered the heart’s electrical activity which could cause serious or life-threatening arrhythmias (heartbeat irregularity).
On Jan. 30, 2009, an FDA advisory committee voted 14-12 against continued marketing of drugs containing PPX. In July 2009, the FDA announced it would allow continued marketing of the drug with a new black box warning that included the risk of fatal overdoses.
However, the result of the new study, in addition to the agency’s review of several large U.S. databases that collect information on side effects and showed a higher rate of deaths associated with the use of PPX than the narcotic pain relievers tramadol (Ultram) and hydrocodone in five-year led the Agency to change its policy on these drugs.
In a statement, Dr. John Jenkins, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research (CDER), said that the drug’s effectiveness in reducing pain was no longer enough to outweigh its serious potential heart risks.
Dr. Gerald J. Dal Pan, director of CDER’s Office of Surveillance and Epidemiology, said that with the new results, “for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart.” According to the FDA, about 10 million Americans took a prescription containing PPX for mild to moderate pain in 2009.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, which petitioned the agency in 1978 and again in 2006 for removal of PPX-containing drugs from the U.S. market, called the delay “a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective pain killer.”
If you or a loved one have been harmed by taking Darvon, Darvocet, or any of their generic forms, contact us today, so we can help you pursue your legal rights against the manufacturer of the drug.