Xanodyne Recalls Darvocet & Darvon: Arrythmia Risk
Propoxyphene: Darvon & Darvocet Pulled From Market
Xanodyne Pharmaceuticals has voluntarily recalled its Darvon and Darvocet painkillers. The FDA is also advising the manufacturers of generic meds containing propoxyphene to do the same.
Clinical trials suggest that propoxyphene, primarily sold as Darvon and Darvocet, can cause dangerous heart arrythmias (irregular heartbeats).
Darvon first hit the market in 1957. More recently, Xanodyne mixed propoxyphene and acetaminophen, selling the new product as Darvocet.
Safety concerns have dogged propxyphene for years. The FDA recieved two advisory committee requests to remove Darvon and Darvocet from the market, but those requests were not followed, though a new study was ordered.
The results of the study: propoxyphene caused heart arrythmias in users of the drug, even if they had healthy hearts to begin with.
The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.
Darvon, which contains the active ingredient propoxyphene, has been on the U.S. market for more than 50 years and was developed by Eli Lilly & Co.