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Medical News & Perspectives
February 12, 2014

FDA Asks Physicians to Stop Prescribing High-Dose Acetaminophen Products

JAMA. 2014;311(6):563. doi:10.1001/jama.2014.716

After only limited success in persuading drug manufacturers to reduce the amount of the painkiller acetaminophen in prescription combination products, the US Food and Drug Administration (FDA) has now called on physicians to avoid prescribing these products if the acetaminophen content is too high. Liver failure, a need for liver transplantation, or death can occur when individuals exceed a certain daily dosage.

In 2011, the FDA gave manufacturers 3 years to voluntarily limit the amount of acetaminophen in prescription combination drugs to no more than 325 mg in each tablet or capsule. The 3-year window closed January 14, and although more than half of manufacturers have complied, some have not.

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