Diabetes Drug Avandia Gets Restrictions From FDA

Sept 23 2010 UPDATE –The Food and Drug Administration (FDA) has decided that Avandia will stay on the market, but the agency has restricted its use to patients whose type 2 diabetes cannot be controlled with other medications.

Avandia first came under careful scrutiny in 2007 when a study published by a cardiologist at Cleveland Clinic showed a 43 percent increase in heart attacks in patients taking Avandia. In June of this year, another study reached similar conclusions, and an FDA advisory recommended tightening restrictions on Avandia’s use.

The FDA’s European counterpart, the European Medicines Agency, has taken more drastic action. It has announced that it will suspend approval for the marketing of Avandia in Europe. If the decision is finalized by the European Commission, Avandia will be removed from the European market.

Avandia Poses Heart and Stroke Risks

July 2010

July 1 2010 ORIGINAL ALERT –A recently published study adds to a growing body of evidence on the danger of the diabetes drug Avandia. The findings come as the Food and Drug Administration (FDA) prepares to hear reports on an outside investigation of the drug.

FDA researcher Dr. David Graham reviewed records of 277,571 Medicare patients who took Avandia and a similar drug, Actos, for three years. Patients who took Avandia had a 27 percent higher risk of stroke, a 25 percent higher risk of heart failure, and a 14 percent higher risk of death compared to those who took Actos. Graham noted that Actos has all the benefits of Avandia but has not been linked to serious side effects.

The FDA will hear an independent panel of experts give its opinion on pulling the potentially dangerous drug off the market on July 13-14.