FDA urges toughest warning label on Avandia

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The Food and Drug Administration is requesting the most serious warning label be put on the diabetes drug Avandia, the agency told Congress yesterday.

Concern over heart problems associated with GlaxoSmithKline's type 2 diabetes drug Avandia rose after a May 21 article in the New England Journal of Medicine that revealed findings from clinical trials of an increased risk of heart attacks for diabetics taking the drug.

The article, written by Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, prompted a congressional investigation into the drug by the House Oversight and Government Reform Committee.

The FDA subsequently issued a safety warning that called on diabetics to consult with their doctors about Avandia but not to stop taking the drug.

The agency emphasized that Dr. Nissen's study did not reflect the agency's own data on the drug. When the FDA approved the drug in 1999, the agency said it would conduct a four-year study on its safety. But the study was only recently completed and is currently under review.

Yesterday, FDA Commissioner Andrew von Eschenbach said the agency does not have sufficient data to conclude Avandia poses an increased risk of heart attacks, But he announced the agency did ask GlaxoSmithKline and Takeda Pharmaceuticals Co., which makes a similar diabetes drug called Actos, to include a "black box warning," the agency's most serious safety warning, to more prominently address the risks of congestive heart failure associated with the use of diabetes drugs.

"Although this issue is already prominent in the warning section for both drugs, FDA decided to make this request because, despite the existing warnings, these drugs were being prescribed to patients with significant heart failure," Dr. von Eschenbach said.

Avandia works differently than some other diabetes medicines. Instead of making the body create more insulin, Avandia lowers a diabetic's blood sugar by making the body's tissues more sensitive to insulin, a hormone that regulates the absorption of sugar into the cells.

The data behind the Journal of Medicine's article were a combination of many clinical trials that showed a 43 percent incidence of heart attacks in Avandia patients.

Moncef Slaoui, chairman of research and development at GlaxoSmithKline, told members of the committee the article was too limited to reach definitive conclusions.

"The most important message today for the committee and the public is this: The cardiovascular profile of Avandia is comparable to that of the two other oral anti-diabetes medicines that are most widely used in the United States today," he said.

Members of the committee differed along political lines whether a hearing on the FDA's role in ensuring the safety of Avandia was necessary. Rep. Henry A. Waxman, California Democrat and committee chairman, stood by Dr. Nissen's data and said the FDA missed several opportunities to warn people about Avandia's risks. He also said the FDA needs more tools to conduct postmarket surveillance of drugs.

"Avandia is a case study of the need for reform of our drug safety laws," Mr. Waxman said. "The FDA needs the will, the resources and the authority to be a more effective watchdog of drug safety."

On the other side, Rep. Darrell Issa, California Republican, accused Mr. Waxman of "politicizing science" and called the hearing premature. "There is not a clear and present danger with Avandia," he said.