The widely used but controversial diabetes drug Avandia will now have a strong “black box” warning on its label, advising users of an increased risk of heart failure, the U.S. Food and Drug Administration announced late Tuesday. Another four diabetes drugs from the same class, including Actos, will also carry a similar black-box message, which is the agency’s strongest label warning. The FDA and the drug manufacturers, GlaxoSmithKline and Takeda Pharmaceuticals, have been negotiating the label changes since May.
Studies have suggested that Avandia (rosiglitazone), made by Glaxo, and Actos (pioglitazone), made by Takeda, raise patients’ odds for heart failure. Other research has suggested that Avandia might possibly raise users’ risk for heart attack, though the FDA has said that more investigation on that issue is needed.
“Under FDA’s post-marketing 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,” Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.
How about a little PRE-marketing surveillance, FDA?