F.D.A. Issues Strictest Warning on Diabetes Drugs
F.D.A. Issues Strictest Warning on Diabetes Drugs
By GARDINER HARRIS
Published: June 7, 2007
New York Times
WASHINGTON, June 6 — The Food and Drug Administration has called for the toughest safety warning on two diabetes drugs, Avandia and Actos, whose health risks have become a focus of Congressional concern.
That decision, disclosed on Wednesday by the F.D.A. commissioner at a packed House hearing, comes more than a year after the agency’s 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 commissioner, Andrew C. von Eschenbach, said the agency has asked the makers of Actos and Avandia to carry the more prominent warning, a so-called black box warning, of its heart risks because “despite existing warnings, these drugs were being prescribed to patients with significant heart failure.”
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