FDA to Require Avandia to Carry Stronger Warnings


FDA Commissioner Andrew von Eschenbach said at a congressional hearing Wednesday that
the FDA is going to require stronger warnings about heart failure on the diabetes drugs Avandia and Actos.

The FDA is directing GlaxoSmithKline to add a “black box” warning to Avandia and ordering Takeda Pharmaceuticals to do the same for its competing diabetes drug Actos, strengthening existing warnings about a condition in which the heart does not adequately pump blood. The issue is separate from an analysis in the New England Journal of Medicine that said Avandia increased the risk of heart attack.

The concerns about Avandia prompted Democratic lawmakers to call for increased regulation of the pharmaceutical industry. Rep. Henry Waxman, D-Calif criticized the FDA for not alerting consumers sooner about the drug’s potential dangers.

“Despite additional warnings from outside experts, despite the millions of patients who rely on Avandia to control their blood sugar, and despite the potential risks involved, FDA never required the manufacturer to conduct a thorough post-market study of its heart risks,” Waxman said.

Waxman called Wednesday’s hearing after the New England Journal of Medicine’s analysis released last month concluded Avandia could raise patients’ risk of heart attack by more than 40 percent.

The FDA Commissioner informed Congress that his agency is still reviewing dozens of often contradictory studies and analyses on the drug’s effects on diabetics.

The British drug maker argues that Avandia is safe and that its own patient studies are the most reliable measure of the drug’s safety, although outside experts say the company’s results are inconclusive.

More than 6 million people worldwide have taken Avandia or a related drug, Avandamet, since it came on the market in 1999. Glaxo reported total U.S. sales of $2.2 billion for the drug last year. Glaxo released the most recent results from a large-scale study of Avandia ahead of the hearing, saying the data shows the drug is no more dangerous than other leading diabetes drugs.

The Senate recently passed a version of a bill that makes major changes to the FDA’s drug safety system. Companion legislation has not yet appeared in the House, though Waxman and other Democrats said they favor giving the FDA more power to require companies to conduct drug safety studies.

Shares of GlaxoSmithKline PLC fell 44 cents to $51.46 Wednesday.


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