Darvocet and Darvon pulled from U.S. market


Darvocet is an opioid painkiller that has been pulled off the market. Image: Flickr / amayzun /CC-BY

After an FDA recommendation, the maker of Darvocet and Darvon has pulled the painkillers off the market. The active ingredient in Darvocet has been shown to cause abnormal heart rhythms. Doctors have been told to quit prescribing Darvocet, though the recommendation also advised individuals with the prescription to continue taking it.

Darvocet pulled off the market

In cooperation with the FDA, the maker of Darvocet and Darvon has removed the product from the market. Propoxyphene, the active ingredient in Darvocet, has been found to cause irregular heart rhythms. Drug approval agencies in the United Kingdom and European Union have already pulled propoxyphene-containing drugs such as Darvocet off the market, as early as 2005. Pharmacists have been instructed to immediately stop filling prescriptions, and doctors are to stop writing prescriptions for Darvocet.

Darvocet questioned in 2009

The active ingredient in Darvocet was first approved by the FDA in 1957. Safety questions have followed the drug for years, and in January of 2006, an FDA panel recommended its removal from the market. The FDA rejected this recommendation, though, in favor of further study of the drug. There were studies going back as far as 31 years, sponsored by drugmaker Lilly, that stated “cardiac conduction depression may be a factor in some of the (human) cardiac toxicities associated with propoxyphene overdose.”

The cost of the Darvocet ban

The recent ban on Darvocet is raising many questions about FDA drug approval and review procedures. It is estimated that about 120 million prescriptions for Darvocet or propoxyphene prescriptions have been filled in the past two years. At approximately $70 per prescription, that means more than $8 billion worth of Darvocet has been sold. The FDA is recommending that anyone who currently has a prescription for Darvocet continue taking the drug and immediately consult with a health care professional to find other alternatives.


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