Trasylol^® Associated with Increased Risks
According to a report in The New England Journal of Medicine, Trasylol (aprotinin) has been found to increase the risk of heart attack, stroke and kidney failure.  The drug is commonly used to prevent excessive blood loss during heart surgery.  Trasylol is given to patients intravenously along with  other medicines so that most people do not even know that they are receiving it. Doctors do not need special permission to administer it.

The study suggested that two other drugs (aminocaproic acid and tranexamic acid) are as effective in preventing blood loss and are safer and cheaper than Trasylol.   According to Reuters Health, Dr. Dennis T. Mangano (the lead author of the report) says the problem may be like recent events surrounding Vioxx but thinks it may be different because the frequency of problems is far greater and the drug has been in use for 13 years.

The study involved 4,374 heart surgery patients who received Trasylol, aminocaproic acid, tranexamic acid or no agent.  Of those, 3,013 patients underwent surgery to open a blocked coronary artery and 1,361 underwent more complex procedures.  The study found that those in the first group that were given Trasylol had significantly increased risk of heart attack, stroke and kidney failure compared with patients who received no treatment. Trasylol was associated with an increased risk of renal failure only with respect to the second group.  Aminocaproic acid and tranexamic acid were both seen to reduce bleeding similar to Trasylol without the increased risks of heart attack, stroke and kidney failure.

Bayer issued a statement saying that it believes Trasylol is a safe and effective treatment. Reuters says Bayer told it that the "findings are not consistent with the more than 15 years of clinical data and experience Bayer has amassed on this drug." Bayer questioned where it was appropriate to use an observational trial as opposed to a randomized trial for this type of study.

What is Trasylol^®?
According to Bayer Pharmaceutical Corporation, Trasylol is a broad-spectrum proteinase inhibitor.  It modulates the systemic inflammatory response during a certain type of heart surgery known as Coronary Artery Bypass Graft (CABG).  CABG surgery redirects blood around clogged arteries to increase blood and oxygen flow to the heart.  The drug was approved in by the FDA in 1993 and indicated for prophylactic use to reduce blood loss and the need for blood transfusion during surgery. According to the NY Times, Bayer is also studying Trasylol in hopes of having it approved to prevent blood loss from hip replacement and spinal surgery.

About Bayer
Bayer Pharmaceutical Corporation is part of Bayer HealthCare AG, which is in-turn a subsidiary of Bayer AG.  Bayer AG is headquartered in Leverkusen, Germany.  Bayer distributes its products through distributors, governmental agencies, wholesalers, pharmacies, and hospitals, as well as directly to patients in North America, Western Europe, and Asia. The company was founded in 1863 and is formerly known as Farbenfabriken Bayer AG and changed its name to Bayer AG in 1972.

Legal Help
Please call or e-mail us for a free evaluation of your legal rights if you have had heart bypass surgery and experienced subsequent heart attack, stroke and kidney failure.

Please e-mail Andrew E. Steinberg* at:  andrewsteinberg@lawyer.com for a free, confidential consultation. Or call us at 713-529-0025.

*Not Certified by the Texas Board of Legal Specialization.   

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