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Acetaminophen must be made safer, FDA panelists agree
American Pharmacists Association, 07/07/09
FDA advisors on Tuesday voted overwhelmingly in favor of a black-box warning and new restrictions on use of acetaminophen, both in prescription and nonprescription products containing the analgesic/antipyretic. On the prescription side, advisors voted 20–17 in favor of a ban on opioid–acetaminophen combinations such as Percocet and Vicodin and favored a black-box warning for any products remaining on the market. The members of Drug Safety and Risk Management, Nonprescription Drugs, and Anesthetic and Life Support Drugs Advisory Committees also advocated reducing the maximum OTC strength of single-ingredient acetaminophen products to 650 mg, making products with higher amount available only by prescription.
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