FDA Panel Votes to Ban Darvon Painkiller

By Alexander Toldt
14:38, January 31st 2009
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Government advisers suggested a ban on the Darvon painkiller which has been in use for the past 50 years but also caused numerous problems from addiction to.

A panel to the Food and Drug Administration voted 14 to 12 to remove Darvon or Darvocent from the U.S. market. However, the panel was advisory and the FDA will have the last word on this issue. Considering the fact that the vote was narrow, it is hard to predict what the FDA will decide.

Darvon, now marketed as Darvocet, was approved in 1957 and was developed by Eli Lilly & Co. (LLY). Later, the company combined propoxyphene with acetaminophen (another pain ingredient) and is now one of the 25 most commonly prescribed drugs.

Public Citizen, a public advocacy organization, has pressed the FDA to pull the drug off the market arguing that it actually offers a weak pain relief and poses an overdose risk.  The advisory panel to the FDA voted as a reaction to the petition of Public Citizen.

On the other hand, the companies that are marketing Darvocet, Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals, said the drug is safe and effective. FDA’s director for anesthesia, analgesia and rheumatology products division, Sharon Hertz, said the agency will consider the option of ordering a post-market study.  In 2007, more than 20 million prescriptions were written for products containing propoxyphene, the FDA said.

In its petition, Public Citizen said the propoxyphene was involved in 5.6% of drug-related deaths and there were 2110 accidental deaths related to propoxyphene from 1981 to 1999, according to data from the Drug Abuse Warning Network.

 



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Tags: Darvon, FDA
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