Trasylol is a medication used to prevent excessive bleeding during surgery and to reduce the need for blood transfusions in patients undergoing heart bypass surgery. The drug is administered in the form of an injection given soon after surgery. It is manufactured by Bayer Pharmaceuticals, and is one of the company's best selling prescription medications with more than 150,000 cardiac patients receiving the medication every year.
Serious side effects have been reported in patients who have been administrated Trasylol soon after cardiac surgery. These risks include a higher likelihood of the development of kidney damage and stroke in cardiac surgery patients. According to one study, the risk of stroke and renal dysfunction are as much as twice the risk in patients who have been administered Trasylol than in patients who have not. In 2006, the FDA imposed limitations on the use of Trasylol and required Bayer to post stronger warnings. The FDA quoted studies that pointed to an increased risk of in-hospital deaths linked to patients who were given Trasylol after undergoing heart bypass surgery.
In 2007, Bayer suspended sales of Trasylol around the world after the Food and Drug Administration made a request calling for the removal of the drug from the American market. According to the FDA's Office of New Drugs, it's not possible to identify a patient population in which the benefits of Trasylol are greater than the risk.
Before the FDA action on Trasylol, studies conducted by an eminent medical researcher, Dr. Dennis Mangano in San Francisco, revealed a strong association between the use of Trasylol and kidney failure that contributed to an increased risk of in-hospital deaths. The study was published in the New England Journal of Medicine and several newspapers across the country. The concern over side effects goes back even further to the eighties, when studies at the Institution of Experimental Medicine at the University of Cologne showed severe kidney damage linked to Trasylol use in animal studies. Bayer, however, was not interested in examining these results further. Soon, the same side effects seen in animals were being observed in cardiac surgery patients across the country.
Bayer's Unethical Behavior
Since Trasylol production was stopped, it has been revealed that the company promoted the medicine aggressively, leading to an expansion of FDA approval for Trasylol use in all heart bypass patients in 1998. By 2006, these promotional tactics were working and Trasylol sales were projected at close to $750 million.
During a presentation of Doctor Mangano’s study to the FDA advisory committee in 2006, Bayer had information from its own study, but the company's representative did not reveal the results of that study, which, most likely, also showed a link between severe kidney failure and Trasylol use in heart surgery patients. The company later claimed that they had withheld this information because the data "was not ready for review."