Naproxène mis hors de cause par la FDA

Pour rappel, la molécule NCX3012 est un composé nitré du Naproxène...
ERSBURG, MD - The big focus at the U.S. Food and Drug Administration advisory panel here is the future of Merck's Vioxx and Celebrex and Bextra, from Pfizer. But this morning, data was presented about another medicine.
Last December, the FDA and the National Institutes of Health issued a warning about naproxen, the active ingredient in Bayer's (nyse: BAY - news - people ) Aleve and Roche's Naprosyn, saying there was a potential increased risk for heart attack and stroke for patients on the drug. The results came from a trial called Adapt, testing naproxen and Celebrex as preventatives for Alzheimer's disease. The statement warned of a 50% increase in cardiovascular events with naproxen.
Top cardiologists almost instantly pounced on the trial. Naproxen was thought to be slightly protective for the heart, like a weak aspirin. Moreover, it had been shown to cause fewer cardiovascular problems than Vioxx. A similar study hinted that naproxen had a heart advantage over an experimental Cox-2 drug from Novartis (nyse: NVS - news - people ).
Today, Constantine Lyketsos from Johns Hopkins Hospital finally presented the results from Adapt. There had been a slight evidence of a risk with naproxen, but the study was stopped because data available from studies indicating a risk with Celebrex made it difficult to convince medical institutions to continue the study. Also, there had been a problem keeping patients on their medicines. "This issue was one more of practicalities than of our internal data," Lykos said.
Tom Fleming, a statistician from the University of Washington, criticized the Adapt investigators for allowing awareness of efficacy data that should have only been available on a separate safety committee.
Another panel member, Steven Nissen of the Cleveland Clinic, likened releasing a warning on naproxen to yelling "fire" in a crowded auditorium. He said he hoped that the medical community could learn from the experience. "It caused a panic that was unnecessary," Nissen said, "and it shouldn't have happened, and I hope it doesn't happen again."
It's still possible that naproxen might have a slight heart risk--some members of the panel are arguing such a risk exists for many painkillers; it's one of the biggest debates for the FDA panel. But many experts seem to think the drug is fairly safe. The FDA's naproxen warning may go down in history as an unnecessary drug scare.

Source : www.forbes.com/sciencesandmedicine/2005/02/18/cx_mh_0218naproxen.html

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