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Date Submitted:
12/12/07
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FDA Seeks Strictest Warning for Diabetes Drugs
Description:
The U.S. Food and Drug Administration has asked that two controversial type 2 diabetes drugs carry a "black box" warning on the potentially heightened risk of congestive heart failure in some patients.
In prepared testimony before a Congressional committee that was convened Wednesday following a published report on the cardiac dangers of Avandia, FDA Commissioner Dr. Andrew von Eschenbach said the agency had asked that Avandia, made by GlaxoSmithKline, and Actos, made by Takeda Pharmaceuticals, carry the more prominent warning because "despite existing warnings, these drugs were being prescribed to patients with significant heart failure." According to von Eschenbach's testimony, the request for the warning -- the strictest one possible -- was issued to both companies May 23, two days after publication of a study in the New England Journal of Medicine that found Avandia (rosiglitazone) increased the risk of heart attack by as much as 43 perce Read the Complete Article Similar content: FDA Seeks Higher Fees From Drug Industry, in Arthritis Group Seeks Refinement of Knee Arthritis Treatment Guidelines, in Arthritis Stroke Warning Signs May Start Days Earlier, in Stroke Pre-Diabetes - Are You Susceptible? Discover How to Prevent It Developing into Type 2 Diabetes, in Diabetes New Hepatitis C Drugs Looking Better, in Hepatitis |
