FDA sued over painkiller petition

6/20/2008

WASHINGTON Yesterday, the consumer advocacy group Public Citizen filed a lawsuit in the U.S. District Court in Washington against the Food and Drug Administration, claiming that the agency violated the law by not ruling on a petition that it had sent within the required six month time period, according to the Associated Press.

The petitioned the FDA two years ago seeking a ban on a painkiller known as Darvocet and Darvon (propoxyphene), calling it no more effective than safer painkillers and citing the accidental deaths of more than 2,000 people since 1981.

Public Citizen is stating that drug is relatively weak, but very addicting. Also, even when used properly it can cause slowed heartbeat and other serious cardiac side effects, the lawsuit says. In addition, Public Citizen’s Sidney Wolfe said it has been deemed inappropriate for the elderly because of other side effects, include sedation and confusion, that increase risk of falls and fractures.

The FDA has not yet responded publicly on the matter.

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