Drug Risk Renews Criticism of FDA

Associated Press
May 22, 2007

First the painkiller Vioxx; now the diabetes drug Avandia. Another big drug safety issue has consumer groups, doctors and congressmen calling for an overhaul of the U.S. Food and Drug Administration.

Yesterday, a medical journal published an analysis suggesting that Avandia raised the risk of heart attacks and possibly deaths. More than 6 million people worldwide have taken the drug to control blood sugar since it came on the market eight years ago, and about 1 million Americans use it now.

Cases like this will continue "until we are able to get a better system of drug approval and surveillance," said Dr. Jerry Avorn, a Harvard Medical School professor and author who has criticized the FDA for not watching more closely for problems with drugs it has approved.

The consumer group Public Citizen said the FDA has failed to require Avandia's maker to adequately warn about the dangers of the drug. And Consumers Union called on the agency to make results of all consumer drug testing public "so doctors, researchers and patients can more quickly know about a drug's possible risks."

Pooled results of dozens of studies on nearly 28,000 people revealed a 43 percent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication, according to the analysis published online yesterday by the New England Journal of Medicine.

The findings are frightening because two-thirds of the people with Type 2 diabetes, the most common form, die of heart problems, so a drug that boosts this possibility is especially hazardous for them.

Still, the actual risks to any single patient appear small. Diabetics should talk to their doctors before stopping any medication, said a statement issued by the American Diabetes Association and two groups of heart doctors.

Avandia's maker, British-based GlaxoSmithKline PLC, disputed the results of the analysis but acknowledged that its own similar review found a 30 percent increased risk — information it gave in August and possibly even earlier to the Food and Drug Administration. But the company said that more rigorous studies did not confirm excess risk.

FDA officials issued a safety alert yesterday and said they likely would convene an advisory panel, but planned no immediate changes to the current side effect warnings on the drug's packaging.

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