Is Trasylol Still Being Used?

Portland, ORFor quite some time, Trasylol has been under fire by the medical community because of the fact that it is estimated the drug has caused approximately 22,000 deaths between being approved by the FDA in 1993 and being voluntarily removed from the market by Bayer, its manufacturer, in November 2007. Ironically, studies conducted as early as 1993 showed that Trasylol has a possible toxic effect on the kidneys.

However, Trasylol was initially approved by the FDA to treat high-bleed bypass operations and not those with minimal bleeding during their surgery, but in 1998 the FDA approved it for all heart bypass operations regardless of the degree of bleeding. In the year 2005 alone, 350,000 patients received Trasylol during their operations and many did not know that they were administered it.

The red flags did not officially go up until Dr. Dennis Mangano did his own independent study and published his findings in the New England Journal of Medicine in 2006. His results showed that those who were given Trasylol during their surgery were at a higher risk of death than those given the alternative. This is the point in which Bayer began defending its product and commissioned its own study that showed results similar to that of Mangano's, but the results were kept from the FDA.

However, it was the study conducted in Canada that sealed the deal when the study could not move forward due to too many deaths. This is what prompted Bayer to "temporarily" suspend the drug until more studies were conducted and the results were more conclusive.

Upon visiting Bayer's website, there is a notice to health care professionals regarding the suspension of the drug. It states that the FDA and the health authorities of other countries are working with them to create a program that allows usage of the drug during the temporary suspension for use in surgical patients who have a medical need for Trasylol. Such a program has not yet been developed.

But there is still concern that has been raised on various message boards on the Internet over continued usage of Trasylol. There are hospitals with it still on the shelves and it appears that there is some still using it while others are refraining from use for liability reasons.

On one of these message boards, a doctor stated that Trasylol is an important adjunct anytime a patient must go on cardiopulmonary bypass. He states that aminocaproic acid and tranexemic acid are not nearly as effective when the patient is undergoing bypass surgery. Furthermore, he says that since the "60 minutes" airing in February, he has used it four or five times and one of those times was on 4-year-old boy. In the times that he has used Trasylol, he says that he has not noticed any decline in renal function in healthy patients after their operation.

Others have said that they have it in stock, but they are not using it. Instead, they are using aminocaproic acid, so the Trasylol is sitting on the shelves in most hospitals.

On Bayer's website for Trasylol, it does state that there is an increased risk of renal failure, but they mostly attribute it to someone who already has some kind of renal-impairment or those receiving other types of drugs that can cause improper renal function. Current studies are now focusing on the risk of those without any type of renal impairment versus those with a renal impairment since Bayer does believe the kidney failure in patients to be due to an already existing condition.

By Ginger Gillenwater