Propoxyphene to be withdrawn from U.S. market - FDA
The Food and Drug Administration announced Nov 19 that Xanodyne Pharmaceuticals Inc. based out of Newport, Ky. has agreed to withdraw its propoxyphene-based pain killers Darvon and Darvocet from the U.S. market as the agency requested.
The FDA also requested the manufacturers of generic propoxyphene containing products to stop selling their products.
Results from trials of propoxyphene, which are consistent with those from epidemiological studies, showed patients using the drug were at risk of potentially serious or even fatal heart rhythm abnormalities.
In the meantime, the FDA is advising health care professionals to stop prescribing propoxyphene to patients and patients who are using the medication to contact their doctors to consider using an alternative pain killer.
Propoxyphene is an opioid indicated to treat mild to moderate pain. The medication was first approved in 1957.
The agency has received two requests since 1978 to remove the dangerous drug from the market. But the FDA was able to make a conclusion today that "the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug."