Diabetes drugs will add heart risk warnings

WASHINGTON -- The diabetes drugs Avandia and Actos will be labeled with severe warnings about a risk of heart failure to some patients, health officials said yesterday.

The makers of the drugs, GlaxoSmithKline PLC and Takeda Pharmaceutical Co., have agreed to add the "black-box" warnings, the Food and Drug Administration said. The warnings, the most severe that prescription drugs can bear, stress the medicines may cause or worsen heart failure and that patients should be closely monitored.

The warnings also apply to combination drugs that include the active ingredients in Avandia, made by Glaxo, or Takeda's Actos.

The warnings, which the FDA said in June it would seek, are separate from concerns that Avandia also raises the risk of heart attack.

Separately, an FDA review of reports of side effects in patients taking either Avandia or Actos found cases of significant weight gain and build up of fluids, both of which are warning signs of heart failure, the agency said.