Arthritis Health Center

Naproxen Warning Unjustified, Say FDA Experts

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Another expert cautioned that studies presented previously during the committee's deliberations suggested that other anti-inflammatory drugs closely related to naproxen may carry heart attack and stroke risk.

"I think we need to accept the fact that all of them have some risk with regard to [heart attack and stroke] risk," said John T. Farrar, MD, a senior scholar at the University of Pennsylvania Center for Epidemiology and Biostatistics.

Bayer Inc., which makes Aleve, released a statement noting that data it submitted to the FDA committee showed no evidence of increased heart attack or stroke risk with the drug when it is taken as directed.

"Bayer believes the evidence presented to the committee and the subsequent discussions support our confidence that Aleve is safe and effective for the relief of minor aches and pain," said Erica Peitler, the company's senior vice president of research and development.

Lyketsos told the committee that ADAPT study leaders will release the study's results on the safety of naproxen and Celebrex in a medical journal within the next few weeks.