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Expert Panel Advises FDA to Pull Vicodin, Percocet
Accidental Overdose and Death Linked to AcetaminophenA 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
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