Darvon and Darvocet Withdrawn From Market Due To Health Risks
On November 19th, the U.S. Food and Drug Administration announced Xanodyne Pharmaceuticals Inc., based in Newport, Ky., agreed to withdraw the drug propoxyphene, sold under the brand names Darvon and Darvocet, from the market. The FDA has also requested the generic manufacturers of propoxyphene-containing products to voluntarily remove their products as well.
Approved by the FDA in 1957, propoxyphene has been under question since 1978 when the FDA received two requests to remove it from the market. At that time the FDA felt the benefits for pain relief at recommended doses outweighed the safety risks. In 2009 the FDA permitted continued marketing but required a box warning be added to the label alerting patients and health care professionals of the risks in taking the drug and ordered Xanodyne to conduct a new safety study about the effects of propoxyphene on the heart.
After reviewing the study, FDA has data showing that the standard therapeutic dose of propoxyphene causes significant changes to the electrical activity of the heart, causing the risk for serious abnormal heart rhythms and even sudden death.
The good news for patients is that once the use of propoxyphene is stopped, the risks will go away.
If you suspect you or a loved one has experienced any of the side effects attributed to Darvon, Darvocet, or any drug containing propoxyphene, please call the experienced prescription injury attorneys at Munley Law Personal Injury Attorneys today or use our online form.
Share this post: