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FDA Panel Says Data Do Not Support Lower Cardiac Risk of Naproxen

Labeling remains unchanged for now (February 11)

According to the FDA’s Arthritis Advisory Committee, available evidence does not prove that the nonsteroidal anti-inflammatory drug (NSAID) naproxen — mainly marketed in the U.S. as Aleve (Bayer HealthCare) and as generic store brand formulations — has a lower cardiac risk than rival products.

The panel was convened after a retrospective analysis of multiple clinical trials, published last year in The Lancet, suggested that naproxen was less dangerous to the heart than other NSAIDs, such as ibuprofen (Advil, Pfizer; Motrin, McNeil) and celecoxib (Celebrex, Pfizer).

The panel recommended that the FDA leave the current product labeling as is, at least pending the outcome of the large PRECISION trial, which is evaluating the long-term cardiovascular safety of celecoxib compared with subscription doses of naproxen and ibuprofen.

The FDA is not obligated to follow the advice of its advisory committees but usually does so.

Sources: Reuters; February 11, 2014; and Pfizer; February 11, 2014.

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