Avandia Gets Heart Attack Warning Label

November 2007

The label of the diabetes drug, Avandia, has been strengthened even further to include a warning about the risk of heart attack. The Food and Drug Administration (FDA) has added to its already strong warning for Avandia, which carries a label that was updated to include risk of heart failure earlier this year.

In August 2007, two leading diabetes drugs, Avandia and Actos, received a black box label, the FDA’s strongest warning label possible. But those label updates only included a warning for risk of heart failure. Risk of heart attack has now been added to Avandia, along with the labels for Avandamet and Avandaryl. Actos will not receive the heart attack risk to its black box label.

Sales of Avandia have shot down nearly 50 percent since this May, when studies pointed to serious heart risks. Medical experts, as well as some FDA affiliates, have speculated that Avandia should be recalled. However, an FDA panel vote ruled 22-1 in favor of letting Avandia remain on the market.