WASHINGTON, Nov. 14 (UPI) -- The diabetes drug Avandia will add information to its warning that the popular drug may increase the risk of heart attack, U.S. regulators said.
People with type 2 diabetes who have underlying heart disease or are at high risk of heart attack should talk with their physician about the revised warning on the anti-diabetic drug, the U.S. Food and Drug Administration said Wednesday in a news release. The FDA advised health care providers to monitor patients who take Avandia to watch for possible cardiovascular risks.
The FDA said it weighed several sources of information, some showing conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.
GlaxoSmithKline, which manufactures Avandia, said on its Web site the FDA directed the sentence, "There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Avandia or any other oral anti-diabetic drugs," be added as a warning on the labels of all oral anti-diabetic medicines.
