Avandia Removed from Retail Market This Week

After this week, the only way to get the diabetes drug Avandia will be through certified mail-order pharmacies, after new restrictions kick in to limit the number of people exposed to potential heart side effects of Avandia. 

Instead of recalling the type 2 diabetes drug, the FDA allowed Avandia to remain on the market last year, subject to a new risk evaluation and mitigation strategy (REMS), which limits sales of the medication to mail order and requires special educational programs before it can be prescribed.

Friday, November 18, 2011, is the last day Avandia will be available on retail pharmacy shelves. To continue receiving the medication after this week, healthcare providers and patients must enroll in the Avandia-Rosiglitazone Medines Access Program by today.

In addition to Avandia, the restrictions also impact Avandamet and Avandaryl, which also contain the active pharmaceutical ingredient rosiglitazone.

Avandia has been removed from the retail market due to an increased risk of heart attacks and heart problems associated with the medication. Some estimates suggest that more than 100,000 heart attacks may have been caused by Avandia since it was first introduced.

A “black box” warning was added to Avandia in the United States in November 2007, but many critics continued to argue that the warning was not strong enough and called for federal regulators to issue an Avandia recall because the risks greatly outweigh any benefit provided by the medication.

Despite a growing body of evidence pointing to an increased risk of heart attacks and death on Avandia, the FDA decided in September 2010 not to remove Avandia from the market altogether in the United States. Instead, the FDA allowed the medication to remain available with severe restrictions on who can use the product.

As a result of GlaxoSmithKline’s failure to adequately research the side effects of their medication or warn about the potential heart risks, the drug maker has faced tens of thousands of Avandia lawsuits filed on behalf of individuals who have suffered serious and sometimes fatal injuries. Avandia settlement agreements have been reached in many of the cases, but approximately 20,000 injury lawsuits are still pending in courts throughout the United States.