Lessons From Trasylol Side Effects And Safety Studies

The New England Journal of Medicine published an editorial in March 2008 title: Learning from Aprotinin – Mandatory Trials of Comparative Efficacy and Safety Needed. The authors concluded the problems that have surfaced regarding Trasylol are going to be repeated in other drugs unless the FDA institutes changes in the requirements of postmarketing studies and restrictions on drug distribution and use. The magnitude of Trasylol kidney failure side effects and the potentially fatal consequences that have affected tens of thousands of heart surgery patients are becoming more and more evident.

The FDA first approved Trasylol (aprotinin) in 1993 to help prevent excessive blood loss during bypass surgery. It is estimated that by 2006, around 200,000 heart surgery patients had been prescribed aprotinin. Dr. Dennis Mangano and a group of researchers raised a red flag in 2006 and 2007 regarding the safety of Trasylol. Dr. Mangano published an observational study that showed Trasylol increased the risks of kidney failure, heart attack, stroke and death. The New England Journal of Medicine, in their editorial, asked the important question “What can we learn from the saga of aprotinin, a drug that apparently confers less overall benefit than cheaper alternatives yet has remained on the market for more than 14 years and become the recommended hemostatic agent for high-risk cardiac surgeries?”

According to the editorial, a crucial piece of the drug approval and monitoring process that is missing is the requirement for more information on infrequent but serious complications and performance relative to alternative drugs. In their opinion, the major lesson to be learned from the current Trasylol problems is that there needs to be head-to-head comparative trials when a new drug has alternatives. This needs to be done before a drug such as Trasylol is routinely administered for a large number of patients. Furthermore, they state that we cannot rely on the drug manufacturers to perform these studies on a voluntary basis because it is not in their commercial or financial interest to do so.

If you or a loved on has suffered from Trasylol kidney failure side effects or has died following heart surgery where Trasylol was used please contact our Trasylol attorneys for a free consultation or help finding out if Trasylol was used during surgery.