FDA sued over failure to ban painkiller

Anne Zieger — Fri, 20 Jun 2008 13:14:36 -0400

A consumer group has sued the FDA over its failure to remove a prescription painkiller from the market, arguing that it's too dangerous to stay on the market. The group, Public Citizen, had petitioned the FDA two years ago for it to ban the drug, propoxyphene, sold under such names as Darvon and Darvocet as well as many generic formulations. To date, the FDA hasn't responded to the group's request.

Now, Public Citizen has filed suit in U.S. District Court in Washington, arguing that the agency had violated the law by not ruling on its petition within the required six-month period. In its materials, the group argues that the propoxyphene is no more effective than other safer painkillers, noting that since 1981, there had been 2,000 accidental deaths associated with it. It also notes that even when used properly, propoxyphene is addictive and can cause serious cardiac side effects.

If the FDA did ban propoxyphene, it would be following in the steps of British health authorities, who ordered the drug to be withdrawn from use in 2005, citing accidental deaths and suicides. Still, right now it remains one of the most widely prescribed generic drugs in the U.S.

To learn more about the case:
- read this Associated Press article
- read the Public Citizen press release

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Petition

FDA sued over failure to ban painkiller