FDA seeks to modernize over-the counter drug reviews

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FDA seeks to modernize over-the counter drug reviews

By Toni Clarke and Bill Berkrot WASHINGTON/NEW YORK (Reuters) - The U.S. Food and Drug Administration is proposing sweeping changes to how it regulates over-the-counter drugs from aspirin to allergy medications to make it easier to react to new information on a product's safety or recommended use. As one example, the FDA has sought to lower the dosage of painkiller acetaminophen from 500 milligrams in widely used products such as "extra strength" Tylenol to 325 mg, based on current knowledge of the liver damage the drug can cause. "We believe the OTC dose should be changed, but it will take a long, long process because it can only change through rulemaking," FDA spokeswoman Andrea Fischer said in an emailed statement. In contrast, the FDA was able to act swiftly to require such a change for prescription pain treatments that contain acetaminophen.

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