OTC Naproxen Labeling: US FDA Advisory Panel Finds Imprecise Direction In PRECISION

Safety study of celecoxib vs. ibuprofen and naproxen spurs advisory committees to recommend adding aspirin-interaction warning on OTC naproxen labels, but many panelist made clear that PRECISION results had not swayed their thinking on celecoxib CV safety or on the OTC ingredients' interaction with aspirin.

FDA Advisory Committee Feature image

A recommendation by a slim majority of US FDA advisory panel members to add label warnings for OTC naproxen's interaction with aspirin might not impress the agency after many said they weren't impressed with a trial that prompted FDA to request their help.

The Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee met in a joint meeting April 24-25 to...

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