Cookie policy notice

By continuing to use this site you agree to our cookies policy below:
Since 26 May 2011, the law now states that cookies on websites can ony be used with your specific consent. Cookies allow us to ensure that you enjoy the best browsing experience.

This site is intended for health professionals only

At the heart of general practice since 1960

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.

Rate this article 

Click to rate

  • 1 star out of 5
  • 2 stars out of 5
  • 3 stars out of 5
  • 4 stars out of 5
  • 5 stars out of 5

0 out of 5 stars

Have your say