FDA requests diabetes drug warnings

Jun 07,2007 00:00 by UPI

WASHINGTON -- The U.S. Food and Drug Administration is requesting safety warnings for diabetes drugs Avandia and Actos after they came under congressional scrutiny.

FDA Commissioner Andrew von Eschenbach announced the move at a U.S. House of Representatives hearing on the FDA's treatment of the drugs, The New York Times reported Thursday.

The FDA's safety reviewers had suggested the step more than a year ago and Congress is looking into why the agency delayed making concerns about the drugs public for several years.

Eschenbach said the agency is asking the manufacturers of the drugs to carry a so-called black box warning about the drugs' possible effects on heart conditions because "despite existing warnings, these drugs were being prescribed to patients with significant heart failure."

Eschenbach said in a written statement that the agency asked the companies to change their labels May 23, two days before a medical journal carried an article that set off the investigation into the potential risks.