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).
The Horsham nonprofit noted that the FDA is reviewing the findings from a new large study of Avandia and is expected to issue a report in July. In the meantime, doctors have been advised to avoid prescribing Avandia to patients with heart conditions.
The institute said patients should not stop using the drug without consulting their doctors. At the same time, patients should be on the lookout for potential problems such as "rapid weight gain; difficulty breathing; swelling of ankles, legs, or stomach; rapid heartbeat, palpitations, and chest pain; and weakness." Such problems should be immediately reported to your doctor.