The US Food and Drug Administration has released a Public Health Advisory alerting doctors and their patients that Bayer’s Trasylol (aprotinin injection), which is used to prevent blood loss during surgery, has been linked to higher risks of serious side effects such as kidney problems, heart attacks and strokes in two scientific publications.
"The FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications," commented Dr Steven Galson, Director of the FDA's Center for Drug Evaluation and Research. "We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients," he added.
Trasylol is the only product cleared by the FDA for the prevention of peri-operative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery, and the agent carries a peak sales potential of over 500 million euros.
But, last month, a study published in the New England Journal of Medicine found that Trasylol more than doubles the risk of kidney failure in patients undergoing open-heart surgery, and a second study, reported in Transfusion, reported more cases of decreased kidney function in patients given the drug compared to an alternative treatment.
In response to the NEJM study, Bayer HealthCare released a statement claiming that its conclusions “are not consistent with the more than 15 years of clinical trial data and experience Bayer has amassed on Trasylol.”
For now, the FDA’s action amounts to just this advisory warning of the potential for adverse events, but an advisory committee meeting is planned for later this year to discuss the existing data and if additional safety measures need to be taken.