Bayer AG has halted worldwide sales of the drug Trasylol (also known as Aprotinin) due to a request for the U.S. Food and Drug Administration (FDA) to take the drug off of the U.S. market for safety reasons. Trasylol is a clotting drug that is used during open heart surgery to reduce bleeding. However studies have found that Aprotinin can increase the risk of kidney failure, heart failure, stroke, brain damage and death compared with alternative drugs. Past studies have linked the drug to a higher risk of in-hospital death to patients having cardiac bypass surgery, and two studies conducted this year found that use of Trasylol during surgery also increases the long-term death rate of patients who underwent bypass surgery. A Canadian study was halted when they saw that their patients receiving Trasylol during surgery had a 50 percent increased risk of death compared with their patients who received other drugs during heart surgery.
Bayer has decided that they will slowly phase out Trasylol from the market so that alternate drugs can be manufactured to replace its void. Bayer has also stated that they would supply the drug to physicians who specifically request it and feel it could be beneficial to their patient. Some trials have shown that Trasylol can control bleeding during surgery better than some alternatives; however, the FDA has stated that it cannot identify a group of patients where the benefits of the use of Trasylol outweigh the risk they put themselves in by using it. Many surgeons have already reportedly stopped using the drug, and few were surprised by the drug’s suspension. In fact a study by Bayer showed that the drug increased the risk of congestive heart failure, stroke, kidney damage and death.
Trasylol was first approved for use in the U.S. market by the FDA in 1993. Concerns about the drug mounted over the years and a study published in the Journal of the American Medical Association found that patients who had been given Trasylol were at an increased risk of dying over a five year period than those given other drugs. Their study tracked 3,900 heart patients who had coronary artery bypass surgery at 62 hospitals around the world. Researchers found that the five year death rate for Trasylol patients was 20.8%, compared to 15.8 percent for those given an alternative drug, aminocaproic acide, and 14.7 percent for those given tranexamic acid.
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