Avandia, GlaxoSmithKline's drug for people with Type 2 diabetes, was linked to more than 1,000 deaths from January through September, 2009, according to an analysis of reports filed with the FDA by the Horsham, Pa.-based Institute for Safe Medication Practices. The nonprofit group, which focuses on preventing medication errors, said that most of the deaths during those nine months were due to heart attacks, heart failure and strokes.
And while the Food and Drug Administration's adverse event reports do not raise new issues about the drug, Avandia has been under intense scrutiny for nearly three years since a 2007 study published in the New England Journal of Medicine reported that it raised the risk of heart attacks and death.
Avandia is Glaxo's brand name for the medication known as rosiglitazone. The company faces a large number of personal-injury lawsuits from people who used Avandia.
In February, The New York Times cited internal FDA documents to report that every month when compared to a similar diabetes drug, Actos, Avandia led about 500 extra people to suffer heart attacks and 300 to develop heart failure. The drug and Glaxo were also criticized by a U.S. Senate investigation led by Sens. Max Baucus (D., Mont.) and Charles E. Grassley (R., Iowa).