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FDA `black box' alert sought for 2 diabetes drugs

June 07, 2007|Ricardo Alonso-Zaldivar | Times Staff Writer

WASHINGTON — The government is seeking its strongest safety warning for Avandia and Actos -- two drugs widely used to treat Type 2 diabetes -- amid heightened concern that heart failure risks associated with the medications are poorly understood, officials said Wednesday.

The disclosure by Food and Drug Administration Commissioner Andrew C. von Eschenbach came during a House hearing on the agency's oversight of Avandia. A recent medical journal article has also linked the drug to an increased risk of heart attacks, a cardiac problem different than heart failure.

Several lawmakers have complained that the FDA was slow to respond to data suggesting an increased risk of heart attacks with Avandia. GlaxoSmithKline, the manufacturer, maintains that the most rigorous research reveals no significant difference in risk between Avandia and other common diabetes drugs.

Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Oversight and Government Reform Committee, called Avandia "a case study of the need for reform of the nation's drug safety laws," because eight years after its approval, the FDA is still uncertain about its heart attack risk.

"Millions of diabetics who have taken Avandia have not been well-served by our regulatory system," said Waxman, whose committee held Wednesday's hearing.

The warning being sought by the FDA -- a "black box" added to prescribing information for doctors -- is for congestive heart failure, not heart attacks. Von Eschenbach said the agency was still trying to sort out conflicting information about heart attack risks with Avandia, and would seek advice from a special scientific panel this summer.

A heart attack comes about suddenly when a part of the heart loses its supply of blood, causing permanent damage to the muscle tissue.

Heart failure is a treatable chronic illness in which a weakened heart gradually loses its ability to pump blood.

Both are serious. Heart attacks kill more than 450,000 people a year in the United States, and heart failure contributes to or causes about 300,000 deaths. People with diabetes are at higher risk of both problems.

Avandia and Actos can cause fluid to accumulate in the body, which can aggravate heart failure. Both drugs already carry warnings about heart failure risks, but Von Eschenbach said in written testimony that "despite the existing warnings, these drugs [are] being prescribed to patients with significant heart failure."

Dr. Robert Eckel, a University of Colorado medical school professor, said stronger heart failure warnings may be appropriate.

"The fact that the FDA has had to reach the stage of a black box means physicians may not be heeding the existing contraindications," Eckel, immediate past president of the American Heart Assn., said in an interview. "From the data we have, I think this risk of heart failure is the one that needs to be increasingly brought to the attention of physicians."

Takeda Pharmaceuticals, which manufactures Actos, said it had agreed in principle to the FDA's request.

A senior Glaxo official, research and development head Moncef Slaoui, declined to answer reporters' questions about his company's discussions with the FDA over the stronger warnings.

In written testimony, he told the committee that Glaxo is discussing ways to "further enhance the prominence" of heart failure warnings.


Times staff writer Karen Kaplan in Los Angeles contributed to this report.

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