An antibleeding drug used during heart surgery has been pulled from the market amidst concerns it may harm more than it helps. Bayer is the maker of recalled Trasylol. The drug may be responsible for a higher risk of kidney failure, heart attack and stroke.
Trasylol is supposed to reduce blood loss and allow patients undergoing heart-bypass surgery to avoid transfusions. The FDA and regulators in Germany and Canada said they are concerned by a clinical study that was suspended by a safety-monitoring board after early results suggested Trasylol might be linked to a 50% higher risk of death than competing drugs. FDA officials on a conference call yesterday said they couldn’t identify a group of patients for whom the drug’s benefits would outweigh its apparent risk.
Trasylol has been used since 1993 by 4.8 million patients. Some lawsuits have already been filed against Bayer before the recall was announced.