Cardiovascular risk warning added to diabetes drug

November 19, 2007

GlaxoSmithKline (GSK) has agreed to add new language to the existing “black box” warning on its type 2 diabetes medication rosiglitazone (Avandia).

GlaxoSmithKline (GSK) has agreed to add new language to the existing “black box” warning on its type 2 diabetes medication rosiglitazone (Avandia). It explains that there is an increased risk of angina and heart attack in patients who take the drug.

The Food and Drug Administration (FDA) is advising physicians to “closely monitor patients who take rosiglitazone for cardiovascular risks.” Rosiglitazone is approved as a monotherapy along with diet and exercise to control blood sugar. It can also be used in combination with metformin and sulfonylureas.

The agency concluded that there’s not enough clinical data to determine whether the risk of heart attack or death vary between rosiglitazone and other oral type 2 diabetes drugs. As a result, it has asked GSK to conduct a new long-term study to evaluate the potential cardiovascular risk of rosiglitazone, compared to other active control agents. The clinical trial is expected to begin in November 2008. For more information, visit, www.fda.gov/bbs/topics/NEWS/2007/NEW01743.html.