Medical Alert Update: FDA Increases Warning Label on Avandia

The U.S. Food and Drug Administration is requiring a “black box” warning that says Avandia, which could cause chest pain or heart attacks. Avandia, a diabetes drug that could increase the risk of heart attacks in some patients, received a more severe warning label November 14, but the government decided against halting sales.

The Food and Drug Administration advised patients taking Avandia with Type 2 diabetes to consult their doctors if they have heart disease or are at high risk of a heart attack. The FDA also urged physicians to closely monitor patients but rejected calls to withdraw the oral drug from the market, saying it needs further study.

On September 11, 2007 a research paper published in the Journal of the American Medical Association (JAMA) found that patients taking Avandia had a 42% greater chance of a heart attack. The results, compiled from four separate clinical trials of Avandia lasting at least one year each, confirm earlier studies suggesting increased cardiological risks from taking Avandia.

In contrast, a separate paper also published by JAMA concluded Actos, a rival diabetes treatment from Takeda Pharmaceuticals, appeared to reduce patients’ risk of heart attacks. The studies did not compare Avandia with Actos.