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Drugmakers should limit doses and strengthen warnings on Johnson and Johnson’s Tylenol and other medicines containing acetaminophen to reduce the risk of liver injury, according to a report posted Wednesday on the Food and Drug Administration’s website. Liver injury has been a known risk of acetaminophen since the late 1990s, and efforts to educate consumers and revise prescribing information have been unsuccessful, the FDA said. While the agency doesn’t want to discourage appropriate use, the proposed restrictions may prevent accidental overdose.
Advisory panels plan to meet June 29-30 to discuss the recommendations.
