PUBLIC HEALTH ADVISORY ISSUED FOR TRASYLOL
The FDA is warning doctors about risks associated with Bayer Pharmaceutical's blood-loss treatment Trasylol, which published studies have linked to increased rates of kidney failure, heart attack and stroke.
In a recent public health advisory, the FDA said it is evaluating the safety profile of Trasylol (aprotinin injection) in light of recent studies that have raised safety concerns about the drug used to prevent blood loss during surgery. A January study in The New England Journal of Medicine (NEJM) found Trasylol doubles a patient's risk of kidney failure and increases risks of heart attack, heart failure and stroke.
"We're working to evaluate the potential risks and determine whether there is a need for further action," said Steven Galson, director of the Center for Drug Evaluation and Research. "In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients." The FDA public health advisory includes the following: Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or through the FDA Medwatch program; and physicians should consider limiting Trasylol use to situations in which the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.
Trasylol is the only product approved by FDA for the prevention of peri-operative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery, the agency said.
The NEJM study found that among primary surgery patients, Trasylol use increased risk of myocardial infarction by 48 percent, heart failure by 109 percent and stroke by 181 percent. A second study, reported in Transfusion, reported more cases of decreased kidney function in patients treated with Trasylol compared to another treatment to prevent bleeding.