In June 2007, during congressional hearings, the U.S. Food and Drug Administration revealed that it has called for the strongest black box warning possible on Actos.
After reviewing postmarketing adverse event reports, the FDA that Actos (pioglitazone), approved to treat Type 2 diabetes, required a black box warning emphasizing that the drug may cause or worsen heart failure in certain patients. The warning covers all thiazolidinedone class drugs including Avandia, Actos, Avandaryl, Avandamet and Duetact.
"Under FDA's postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "This new boxed warning addresses FDA's concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure."
[Source: U.S. Food and Drug Administration]
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» Drug Warnings and Withdrawls for 2007 from PharmaGazette
FiercePharma has compiled a list of the top 10 drugs to have who have had approval either withdrawn or been forced to add stronger warning labels, by the FDA, with respect to their pharmaceutical products. The list is based on 2006 worl... [Read More]
Tracked on: December 5, 2007 2:41 PM | Permalink to Trackback