Safety of diabetes drug attacked by FDA official

June 16, 2010

in Health News

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(Reuters) – The diabetes drug Avandia, known generically as rosiglitazone, exposed patients to greater health risks including heart attacks, and even death, the Wall Street Journal said, citing a U.S. Food and Drug Administration scientist’s study.

Patients in the U.S. Medicare system who took the drug may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009 that could have been averted had they taken a different drug, the study concluded.

The unpublished study by David Graham, an FDA drug-safety official and long-time Avandia critic, said patients taking Avandia had a 27 percent greater chance of suffering a stroke, a 25 percent increased risk of suffering heart failure and a 13 percent greater chance of dying.

Data for the scheduled July review of the drug’s safety by the FDA will include Graham’s study, the newspaper said.

Prescriptions for the drug declined sharply following controversy over the drug’s heart risks in 2007. That year, a study by the Cleveland Clinic’s Steven Nissen said Avandia was linked to a 43 percent greater risk of heart attack, the Journal said.

While worries about liability claims have spiked since a February critical report on the drug by two U.S. senators, Glaxo has consistently defended the safety record of Avandia, saying it appropriately communicated the medicine’s potential heart disease-related risks to regulators and physicians.

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