Glitazones get 'boxed' warning in US
Glitazones will carry a ‘boxed' warning of their increased risk of heart failure, the US Food and Drugs Administration announced this week.
The boxed form, considered to be the strongest form of a warning for drugs, will be applicable to the entire glitazone class of drugs, including rosiglitazone, pioglitazone and combinations of rosiglitazone and glimepiride, rosiglitazone and metformin and pioglitazone and glimepiride.
The strengthened warning advises healthcare professionals to observe patients carefully for signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath and edema.
It also states the drugs should not be used by people with serious or severe heart failure that limits their activity.
'This new boxed warning addresses the 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,' said Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
The FDA has asked drug manufacturers GlaxoSmithKline and Takeda to address these concerns.
An expert committee had previously recommended that the FDA continue to market the type 2 diabetes drug rosiglitazone despite an analysis that found an increased risk of MI and cardiovascular death. It advised companies to provide more information of risks on their labels.