OTC NSAIDs Need Additional Label Warnings – FDA Advisory Panel
This article was originally published in The Tan Sheet
Labels for OTC NSAIDS need additional information about potential risks, say panel members in a joint meeting of the Arthritis and the Drug Safety and Risk Management advisory committees. Data do not show naproxen has a lower CV thrombotic event risk compared to other NSAIDs, they say.
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FDA’s Arthritis and Drug Safety and Risk Management advisory committees on Feb. 10-11 will examine cardiovascular risk data for non-steroidal anti-inflammatory drugs, including meta-analyses indicating naproxen could have a better safety profile than other OTC ingredients ibuprofen and ketoprofen.
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