In the wake of published research possibly linking diabetes drug Avandia to heart risks, federal regulators said reports of the drug’s side effects tripled in a single month, according to an Associated Press report released July 13, 2007. The Associated Press obtained the information from the FDA through a Freedom of Information Act request.

In the 35 days prior to the New England Journal of Medicine’s published analysis, the FDA received reports of five heart attacks and 11 heart-related hospitalizations concerning rosiglitazone, the drug in Avandia and Avandamet. However, 35 days after the report, the FDA received reports of 90 heart attacks and 126 heart-related hospitalizations involving the same drug. The FDA received reports of 11 deaths in the 35 days prior to the study, compared to 38 in the same time after.

Dr. David Graham, a drug-safety expert with the FDA, said consumers “can’t infer anything about incidence rates” from the increased reports because the increase is likely due to the study’s “publicity effect.”

Dr. David Nathan, the head of diabetes care at Massachusetts General Hospital, echoed Dr. Graham when he said it was “not conceivable” that only five in one million Americans taking Avandia had heart attacks in the month preceding the study.

Source: Marilynn Marchione, “Diabetes Drug Side Effect Reports Triple,” Associated Press, July 13, 2007.