Xanodyne Pharmaceuticals, Inc. is cooperating with the FDA in recalling Darvocet and Darvon, their versions of the pain killer propoxyphene. Darvon, which is also sold as Darvocet (with acetaminophen added), could cause serious and potentially fatal heart rhythm abnormalities, according to new clinical data reviewed by the FDA.
An outside advisory panel to the FDA recommended last year that Darvon and Darvocet be pulled from the market after concluding that the pain relief benefits of the drugs didn’t outweigh the significant risk of side effects related to overdose and addiction. However, the FDA is not required to follow the advice of the panel, and the two pain killers remained on the market until recent electrocardiography data from a clinical study revealed QT interval abnormalities occurred in healthy people taking normal doses of the drugs.
The main active drug in Darvocet and Darvon is propoxyphene, which the FDA has also removed from the market, affecting other generic versions of this widely prescribed pain medication.
Doctors have been asked to stop prescribing these drugs, and patients taking the medication are being advised to see their physician to discuss switching to another pain killer.