FDA advisory panel to consider OTC status of NSAIDs

SILVER SPRING, Md. — A pair of Food and Drug Administration advisory committees will be meeting Feb. 10 to talk about heart risks associated with use of NSAIDs and whether or not Bayer's Aleve (naproxen) carries a lower risk profile than other NSAIDs. The FDA is also considering potentially revoking OTC status of certain nonprescription NSAIDS, according to published reports

However, the lower doses of OTC pain relievers relative to prescription-only and the short duration those pain relievers are supposed to be used to alleviate acute pain could be factors in favor of keeping ibuprofen, ketoprofen and naproxen as nonprescription pain relief options.

In addition, FDA is asking advisers to consider whether an ongoing safety study of Pfizer's Celebrex as compared to ibuprofen and naproxen should continue as naproxen is seen as safer. 

The labeling for non‐prescription NSAIDs was revised in 2005 to include more specific information about potential cardiovascular and GI risks following the recalls of cox-2 inhibitors Vioxx and Bextra.

Three NSAIDs are approved in the U.S. for over-the-counter use: ibuprofen at doses up to 1,200mg/day, ketoprofen at doses up to 75 mg/day and naproxen at doses up to 660 mg/day.

 

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