The Food and Drug Administration might stop a safety study involving thousands of patients taking GlaxoSmithKline’s diabetes drug Avandia. The decision could also determine whether the drug remains on the market, the Wall Street Journal reports.
Knowledge of the drug’s link to an increased risk of heart attack goes back to 2007. Avandia is part of a Glaxo-sponsored trial comparing it with Actos, a diabetes drug by Takeda Pharmaceutical. Though the trial is FDA-approved, some scientists inside and outside the agency have said it is unethical to compare a drug with known cardiac risks with a seemingly safer alternative, the Journal reports.
In 2007, an FDA advisory panel voted 22 to 1 to keep Avandia on the market but also voted 20 to 3 that it increases the risk of a heart attack.
