Washington – A drug widely used to control diabetes increases the risk of heart attacks and possibly death, researchers reported Monday, raising alarm about another popular prescription medication.
The drug, Avandia, taken by about 1 million Americans to keep their blood sugars at safe levels, boosts the risk for heart attacks by 43 percent and may increase the risk of dying from such an attack or stroke by 64 percent, according to a new analysis.
“This is very concerning,” said Steven Nissen of the Cleveland Clinic, who conducted the analysis released early by the New England Journal of Medicine because of its public-health implications. “When you have a drug widely used in a population with a high inherent rate of heart disease, it’s very, very concerning.”
Nissen and others advised patients taking the drug to immediately consult with their doctor.
“I don’t see a rationale for using this drug,” said Bruce Psaty of the University of Washington, who co-wrote an editorial accompanying the study. “The purpose of taking this drug is to prevent a heart attack, and this indicates it actually increases the risk.”
GlaxoSmithKline, which makes the drug, defended its safety, saying the analysis had fundamental limitations and that other large, more reliable studies have found no evidence of increased risk.
“We are confident in the benefit-risk profile for Avandia,” said Ronald Krall, the company’s chief medical officer. “It is an important treatment for patients with Type 2 diabetes,” the most common form of the disease.
Nevertheless, the report prompted calls for the Food and Drug Administration to take some kind of action in response, either by issuing warnings about the drug’s safety or possibly pulling it.
During a hastily convened telephone briefing with reporters, agency officials said they had been evaluating the safety of the drug but had received conflicting data that showed no signs that it was dangerous. As a result, they said, it was premature to take action.
“At this point, we have not reached a definitive conclusion,” said the FDA’s Robert Meyer.
