Bayer Heart-Surgery Drug Gets New Warning

The U.S. Food and Drug Administration has toughened the warning on Bayer’s heart-surgery drug Trasylol regarding increased risk of kidney damage.

The agency added that the drug’s labeling has also been revised to reflect a narrower use, limited to patients at a higher risk for blood loss during coronary bypass graft surgery.

Trasylol has been in the FDA’s crosshairs since a pair of published studies suggested the increased risk of kidney damage.

The purpose of the label change is to inform physicians and patients about the risks associated with Trasylol and to ensure they understand the new warnings and use the product as directed by the label, Steven Galson, head of the FDA’s Center for Drug Evaluation and Research, said in a statement.