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Naproxen Warning Unjustified, Say FDA Experts

Report Linking Aleve to Heart Attacks Unnecessarily Scared Public


Studies have suggested that naproxen may carry a lower heart risk than Cox-2 drugs, but researchers remain unsure of its heart safety since it has never been tested against a placebo.

The announcement "had the effect that was the equivalent of screaming 'fire' in a crowded auditorium," said Steven Nissen, MD, a panel member and medical director of The Cleveland Clinic.

Nissen said he and other cardiologists were forced to field calls from hundreds of frightened patients who had read media reports of naproxen's dangers.

"It caused a panic that was unnecessary, and it shouldn't have happened, and I hope it doesn't happen again," said Nissen. "We can't do business this way."

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.

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