A draft study by an FDA scientist has linked side effects of Avandia to tens of thousands of heart problems among elderly users, and suggests that more than 100,000 Americans may have suffered heart attacks, strokes or other problems from Avandia since the drug was introduced.
The draft Avandia study (pdf) was performed by drug safety reviewers from FDA and the Centers for Medicare and Medicaid Services (CMS). According to a story by Pharmalot, a drug reviewer at the FDA is pushing for the study to be published in a medical journal in the near future, while the FDA is continuing its own analysis of the safety of GlaxoSmithKline’s diabetes drug.
The researchers performed an observational study looking at data from more than 227,000 Avandia users over the age of 65 and compared those with users of the competing diabetes drug Actos, by Takeda Pharmaceuticals. They found that in that age group, Avandia increased the risk of stroke by 27%, the risk of heart failure by 25%, and the risk of death by 13%. Overall, the researchers estimated that 48,000 elderly users experienced an event attributable to Avandia side effects.