Avandia Safety Label Updates

On Nov. 14, 2007, the U.S. Food and Drug Administration (FDA) announced that the manufacturer of Avandia (rosiglitazone) is adding new information about potential increased risk for heart attacks to the existing boxed warning. This action follows recommendations made at the July 2007 joint meeting between FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. Avandia is used to treat Type 2 diabetes and is manufactured by GlaxoSmithKline in Philadelphia, Pa. The changes to the labeling are outlined below.

Heart Failure Warning

Heart failure warnings now state that Avandia should be discontinued if any deterioration in cardiac status occurs. An existing warning has been revised, stating that Avandia is not recommended in patients with New York Heart Association Class 3 or 4 cardiac status. New labeling includes safety data from clinical trials showing that an increased incidence of cardiac failure and other cardiovascular adverse events was seen in patients receiving Avandia and insulin compared to insulin alone.

Precautions

Changes to Precautions on the safety label include edema and the potential issues relating to combination use with insulin. Additionally, precautions regarding the hepatic effects of Avandia now include post marketing reports of adverse events. Information regarding weight gain and the use of Avandia in combination with insulin has been added.

Adverse Reactions

The Adverse Reactions section on the safety label has been updated to include reports of adverse events of edema and congestive heart failure when Avandia is used in combination with insulin. In addition, the Adverse Reactions section now shows reports of hepatic events and events potentially related to volume expansion.

Consult a Lawyer

If you or a loved one has been harmed by Avandia, you should contact an Avandia attorney to find out whether you are eligible for compensation for your injuries.