FDA Recommends Discontinuance of High-Dose Acetaminophen Combination Drugs

The FDA issued a recommendation on January 14 that health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. Limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death. This action accompanies a similar recommendation issued in January 2011 to manufacturers of these products that this acetaminophen limit be adopted. Read the FDA news release here.


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