US FDA places heart warning on GSK's Avandia

Source: Exec

Date :15/11/2007 13:57:36

The U.S. Food and Drug Administration have added a "black box" warning to GlaxoSmithKline's diabetes drug, Avandia.

The top-selling drug will carry a warning that it could cause chest pain or heart attacks; however, the FDA decided against halting sales, saying it needs further study.

"We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's Dr. Janet Woodcock said.

According to the release, the FDA has also requested that GSK conduct a new long-term study to further evaluate the potential heart risks of Avandia.

In the meantime, doctors should monitor patients closely for any heart effects, the FDA advised.

Continuous study

However, GSK backed the type-2 diabetes drug in a statement issued Wednesday.

"Avandia remains a safe and effective medicine for most patients with type 2 diabetes when used appropriately," said Dr. Ronald Krall, GSK's chief medical officer in the press release.

"Given the severity of this disease and the importance of Avandia in helping patients manage their diabetes, we will continue to work with the FDA to conduct more studies about the safety and benefits of our medicine."

The label changes also apply to two related drugs sold by GlaxoSmithKline: Avandamet and Avandaryl.

November 15, 2007