Sunday, August 19, 2007

Avandia and Actos Get Blackbox

Avandia and Actos will carry U.S. regulators' strictest warning on the risk of heart failure.

The drugmakers agreed to a black box warning on prescribing information.

An analysis of existing research published last month in the journal Diabetes Care found that Avandia and Actos doubled the risk of heart failure in diabetics. Use of Avandia and Actos may increase the likelihood by causing fluid retention or swelling, which can make the heart work harder. The study found that a quarter of heart-failure cases occur in people younger than 60.

``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. Source here.