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    Tuesday, December 21, 2004

    Got Arthritis? Suck it Up: Now the FDA is warning that one of those old stand-by arthritis drugs that are supposedly safer than the newer ones like Celebrex and Vioxx aren't safe either:

    The Food and Drug Administration issued a warning to users of the over-the-counter pain reliever naproxen Monday after federal researchers found an increased number of heart attacks and strokes among users.

    The warning springs from an NIH study which was being done to see if Celebrex or Naprosyn would decrease the incidence of Alzheimer's disease in those over 70 years of age. The researchers reported a 50% increase in heart attacks and strokes in those taking Naprosyn over those taking Celebrex. Confused? We all are. As usual, details are sparse, but this CNN report offers some information:

    The Alzheimer's disease study was being conducted by the National Institute on Aging, an arm of the NIH. It called for 2,500 patients, aged 70 or older and who had a family history of Alzheimer's, to take either Celebrex, naproxen or placebo.

    The group was divided and each division, or arm, was assigned to receive one of the drugs or placebo. The drugs were blinded, which means the patients did not know which medication they were taking.

    John Breitner of the Veterans Affairs medical facility in Seattle and the University of Washington, an investigator in the trial, said only preliminary data is available. But he said it suggests that about 70 patients of the 2,500 suffered stroke or heart attack, including 23 deaths, and that there were about 50 percent more such events in the naproxen arm of the study than in the placebo division.

    That's 70 strokes or heart attacks in the entire study, which means the numbers of heart attacks and strokes in the two groups were exceedingly small. That translates into 42 strokes or heart attacks in the 1250 people who took Naprosyn and 28 strokes or heart attacks in the 1250 people who took Celebrex, or 3% vs. 2%. Please note that 97% of people taking Naprosyn had no strokes or heart attacks, and 98% of people taking Celebrex had none.

    And if drugs like Vioxx and Celebrex cause heart disease and strokes because their biochemistry increases the likelihood of clotting, as many critics have suggested, then why would Naprosyn, which has a biochemistry detrimental to clotting, be riskier than Celebrex? Because the findings have all been based on small and insignificant numbers. The difference between 3% of people having a complication and 2% is clinically meaningless.

    It's too bad that we've decided to exaggerate the risks of these drugs. If we keep it up, we won't be able to prescribe anything.

    posted by Sydney on 12/21/2004 08:32:00 AM 0 comments


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