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.”
Please visit the website to view the entire article.
Copyright 2007 The New York Times Company
Votes:21
Comments: 0