An analysis of four clinical trials involving more than 14,000 patients found that diabetes medication Avandia (rosiglitazone) taken over a lengthy period of time increases the risk of heart attack by 42 percent, a report released Tuesday said.
It marks one of the first studies to look at how use for one year or longer of Avandia, in patients with type 2 diabetes, affects risk of heart attack, heart failure and mortality, according to authors of the study in the September 12 issue of the Journal of The American Medical Association (JAMA).
The Food and Drug Administration recently required a label to be put on Avandia, made by British drugmaker GlaxoSmithKline, and similar treatments, warning of increased risk of heart failure.
An analysis of 42 short-term clinical studies published in May in the New England Journal of Medicine found that Avandia boosts heart attack risk by 43 percent.
"The public health impact of potential harm with rosiglitazone is substantial," said Sonal Singh, MD, lead author and an assistant professor of internal medicine at Wake Forest. "Regulatory agencies should urgently evaluate whether this drug should remain on the market."
"There is no need for physicians, health plans or patients to wait for regulatory action," added Curt Furberg, a co-author of the report. "On the contrary, they should take prompt action and restrict the use of Avandia, especially since safer alternatives are available."