More clinical studies question Avandias safety

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Two clinical studies published in The Journal of the American Medical Association are raising questions about the safety of drugs such as Avandia, made by GlaxoSmithKline, a once-popular diabetes medication, according to The New York Times.

The findings of one study said that Avandia doubled heart failure risks and raised the risk of heart attack by 42 percent, while a second study found that Actos, a similar drug made by Takeda, lowered the risks of heart attacks, strokes and death but, like Avandia, raised the risk of heart failure.

According to The Times, the controversy began in May when The New England Journal of Medicine published a combined analysis of more than 40 studies of Avandia that found that it significantly raised the risk of heart attacks.

In June, the U.S. FDA placed warnings concerning heart failure risks on the labels of Avandia and Actos. In July, a federal advisory panel voted overwhelmingly to keep Avandia on the market, even though it raised the risks of heart attack.

“If you use Avandia to treat patients with Type 2 diabetes, their chance of getting heart failure due to Avandia is one in 30 and their risk of getting a heart attack is one in 220. All due to the drug,” Sonal Singh, MD, an assistant professor of internal medicine at the Wake Forest School of Medicine and a co-author of the study, told The Times.

In an editorial accompanying the study, two doctors from Brigham and Women’s Hospital in Boston wrote that Avandia would probably not have been approved in 1999 had its heart risks been known.

In an interview with The Times, Daniel Solomon, MD, co-author of the editorial, called Avandia “a drug of last resort.”