Avandia Restrictions Put in Place in U.S.

Avandia will no longer be found on most U.S. pharmacy shelves after November, as part of a risk evaluation and mitigation strategy (REMS) designed to reduce patients’ exposure to the risk of heart problems from Avandia. 

The FDA announced the new Avandia restrictions on May 18, indicating that the medication will only be available from select pharmacies by mail order and special educational programs will be required before the drug can be prescribed.

The new restrictions on Avandia, which also apply to Avandamet and Avandaryl, were put in place after the FDA decided not to issue a recall for the diabetes drug, despite a known increased risk of heart attacks.

Use of Avandia will be restricted to individuals already being successfully treated with the drug, whose blood sugar can not be controlled with any other anti-diabetic medications. In addition, it is necessary that patients consult with their healthcare provider and indicate that they do not want to use Actos or another pioglitazone medication, such as Actosplus Met, Actosplus Met XR or Duetact.

Avandia (rosiglitazone) was first introduced in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics throughout the world, but sales began to plummet in mid-2007, after potential Avandia heart risks were highlighted in a study published by the New England Journal of Medicine.

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 an Avandia recall to be issued in the United States.

Despite heated internal debate, the FDA decided in September 2010 not to recall Avandia in the United States, allowing the medication to remain on the market with severe restrictions on who can use the product.

GlaxoSmithKline has faced thousands of Avandia lawsuits in the U.S. filed by people who allege that the drug maker failed to adequately warn about the risk of heart problems from Avandia. A number of Avandia settlements have reportedly been reached by GlaxoSmithKline in an effort to resolve the litigation, but thousands of cases are still pending in courts throughout the country.