Expert Panel Advises FDA to Pull Vicodin, Percocet

Accidental Overdose and Death Linked to Acetaminophen

A panel of experts voted 20 to 17 in favor of eliminating the prescription pain killers Vicodin and Percocet, both widely prescribed drugs.

The reasoning is based on a review of adverse event data including liver failure, related to accidental overdoses from prescription pain killers. The panellists cited data which show a 60 percent death rate associated with acetaminophen-containing prescription drugs.

Additionally, the panelists voted 36-1 to place a black box warning on the drugs, should they remain on the market.

Regarding over-the-counter drugs containing acetaminophen, including Tylenol and Nyquil, the panel voted 26-16 in favor of lowering the maximum daily dose from 4 grams or 8 pills. However, they were not asked to recommend a new daily dose.

In a further vote, the panel recommended reducing the maximum single acetaminophen dose to 650 mg. Currently, a single dose of extra strength Tylenol is 1,000 mg, or 2 tablets, which the panel suggested should be available by prescription only.

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Published on Jun-30-09