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FDA causes unnecessary scare about common painkillers

and 63 percent higher, respectively, than placebo. An analysis of a large number of trials comparing COX-2 inhibitors to other NSAIDs found similar results ?that Voltaren was estimated to increase vascular risk by about 70 percent over Aleve.

"Naproxen does not increase the risk of heart attacks and ought to be a painkiller of choice," said Furberg. "On the other hand, Voltaren carries the same risk as the harmful COX-2 inhibitors Bextra® and Vioxx®, which have been taken off the market.

"The FDA has failed to recognize the evidence that the risk of heart attack varies substantially among this group of drugs and that Voltaren has the highest risk of all. Since it is the most commonly used NSAID, the unrecognized harm it has caused worldwide could be enormous."

The European Regulatory Agency has reviewed the same evidence that the FDA considered and reached entirely different conclusions, said Furberg. He said this suggests that the decisions are not based on scientific evidence.

With Celebrex, the FDA didn't follow the recommendations of its Advisory Committee to substantially restrict the drug's use. Instead, it required only a "vaguely worded" black box warning, said Furberg. European countries require clear warnings for patients at high risk of heart attacks and have said COX-2 inhibitors should not be taken by patients with heart disease.

With the non-selective NSAIDs, Europe has given a "clean bill of health" to the agents and the FDA has judged them to have similar risks to Celebrex and is adding "black box" warnings.

"Decisions by regulatory agencies are expected to follow explicit regulations and should be evidence-based," said Furberg. "Scientific studies point to clinically important differences among the non-selective NSAIDs, which the FDA has not recognized. It's time for the FDA to set the record straight."


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Source:Wake Forest University Baptist Medical Center


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