World and Nation

FDA Issues Its Strictest Health Warning on Two Diabetes Drugs

The government's top drug regulator told a packed House hearing Wednesday that the agency had recently decided to put the agency's most serious safety warning on two diabetes drugs — Avandia and Actos — whose health risks have become a focus of congressional concern.

The decision comes more than a year after FDA safety reviewers strongly recommended just such a step, and it occurs amid a congressional investigation into why the agency delayed its warnings about Avandia for years.

In a written statement, the Food and Drug Administration commissioner, Andrew C. von Eschenbach, said the agency was asking the makers of Actos and Avandia to carry a more prominent warning of its heart risks because "despite existing warnings, these drugs were being prescribed to patients with significant heart failure."

The statement said the FDA requested the label changes on May 23, which would have been two days after an article and editorial about Avandia's potential heart risks set off the current controversy. Word of the label changes, however, had not been made public before Wednesday.

Avandia, a Type 2 diabetes treatment made by GlaxoSmithKline, has been the focus of most of the recent safety concerns, based on evidence that it can potentially cause heart attacks or other cardiovascular problems. But its closest competitor, Actos, a drug from Takeda Pharmaceutical and Eli Lilly & Co., has also been seen as carrying some risk of problems including heart failure.

Democrats on the panel voiced harsh criticism of the FDA on Wednesday.

Rep. Henry Waxman, D-Calif. who is chairman of the panel, the House Committee on Oversight and Government Reform, said the FDA "dropped the ball" in its oversight of Avandia's safety. The agency should have insisted years ago that Glaxo test whether Avandia increased the risks of heart attacks, he said.

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

But some Republican members of the committee criticized Democrats on the panel for making too much of uncertain information about a popular diabetes pill.

Rep. Virginia Fox, R-N.C., said she was concerned that those studying the drug had spoken to Democrats on the committee but no one at the FDA.

"I'd like members of the press to investigate what members of Congress knew about this" and whether those members joined with some FDA staff members and others "to create maximum embarrassment to the agency," she said.

Rep. Darrell E. Issa, R-Calif., said that the committee was coming dangerously close to "politicizing science."

Rep. Tom Davis of Virginia, the ranking Republican on the committee, was less critical of the FDA than the Democrats, but still said he was also looking at the Avandia example as a lesson in "how we can strengthen FDA drug approval and post-marketing surveillance systems."