THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING

Senators press FDA for answers about why diabetes drug still on market

By Rob Waters
Bloomberg News / February 21, 2010

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SAN FRANCISCO - Safety reviewers at the Food and Drug Administration urged the agency to take GlaxoSmithKline PLC’s diabetes drug Avandia off the market in 2008 because they said it was causing 500 additional heart attacks per month. Two US senators say they want to know why the medicine remains on pharmacy shelves.

A report released yesterday by Max Baucus and Charles Grassley said Glaxo knew Avandia may cause heart damage several years before a study documented the risk and the company pressed doctors to retract warnings about side effects.

Baucus, chair of the Senate Finance Committee, and Grassley, the committee’s ranking Republican, are pressing the FDA for answers by March 4.

A 2007 study published in the New England Journal of Medicine linked Avandia to a 43 percent increased risk of heart attack.

Two FDA officials also reviewed the drug’s safety and concluded in their 2008 report that Avandia was exposing users to higher risks for heart attacks without being any more effective than a rival drug, Takeda Pharmaceutical Co.’s Actos.

Glaxo, in a statement yesterday , said it rejects conclusions that Avandia is risky for patients.

In the 2008 report, the FDA safety officers also said that a medical trial comparing Avandia with Actos that was being planned would be “unethical and exploitive’’ because it would expose patients to unwarranted risks.

That trial, called TIDE, which was planned to involve a total of 16,000 patients, is now under way.

Baucus, a Montana Democrat, and Grassley, an Iowa Republican, sent a letter to the FDA on Thursday asking what steps the agency was taking to protect patients in the trial.

Karen Riley, an FDA spokeswoman, said in an e-mail that the agency is “reviewing the report from the senators, we take it very seriously and we will reply quickly.’’

The risks were described in yesterday’s New York Times in a story based on the Senate report and other documents.

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