Avandia Label to Get Heart-Attack Warning

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By Steven Reinberg
HealthDay Reporter
Wednesday, November 14, 2007; 12:00 AM

WEDNESDAY, Nov. 14 (HealthDay News) -- The popular diabetes drug Avandia -- which has been linked to the risk of heart failure and, more recently, heart attack -- will carry a revised "black box" warning noting the heart attack risk, even though the research on heart attack is inconclusive, U.S. officials said Wednesday.

GlaxoSmithKline, the maker of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add the new warning to the existing black box warning on the drug's label, according to U.S. Food and Drug Administration officials.

"We are announcing an update to the existing box warning on Avandia," Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research, said during a midday teleconference. "A black box is the strongest form of warning, and we are adding another warning to that black box."

Despite the revised warning label, the FDA said it isn't seeking to have the drug withdrawn from the market, because the evidence for the increased heart-attack risk is not conclusive.

"We are keeping Avandia on the market, because we have concluded there isn't enough evidence to indicate that the risk of heart attack is higher for Avandia than other type 2 diabetes treatments," Woodcock said.

Woodcock said the FDA has asked GlaxoSmithKline to conduct a long-term study comparing Avandia with other type 2 diabetes drugs. The trial will most likely start in a year, and full results won't be available until 2014.

Dr. Steven Nissen, chairman of the Cleveland Clinic's department of cardiovascular medicine, first raised concerns about Avandia and heart-attack risk in a study published earlier this year. He said he welcomed "the addition of a black box warning for the risk of heart attack from Avandia," but would have preferred a warning "written with greater clarity," like the one used by Health Canada, the FDA's counterpart in Canada.

The Canadian labels says Avandia is not to be used as the sole medication for type 2 diabetes except for patients who can not take another drug -- metformin -- that also lowers blood sugar. The label also states that Avandia is not to be used by any patient with heart failure.

"This is a much clearer statement than the FDA statement," Nissen said.

Nissen said he was also bothered by the proposed trial that ends in 2014. "It really doesn't solve the problem of what to do in the meantime," he said. "I hope the appearance of a black box warning will be enough to keep people from being harmed."

The new FDA-mandated labeling change follows recommendations made by the FDA's Endocrine and Metabolic Advisory Committee and Drug Safety and Risk Management Advisory Committee. In July, the committees recommended keeping Avandia on the market, pending a review of additional data. The committees also said the drug's label should carry a warning of the potential for increased risk of heart attacks.

Controversy over Avandia started in May, when a study by Nissen and colleague Kathy Wolski, published in theNew England Journal of Medicine, found a 43 percent increased risk of heart attack among patients taking the drug. Nissen said he uncovered the risk after poring over data from 42 studies of Avandia.


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