Trasylol Lawyer & Attorney : Fields Law Firm : Trasylol Injury, Kidney & Heart Failure

Trasylol lawsuits have been filed throughout the United States alleging that the heart surgery drug is a defective medication. They state that Trasylol (aprotinin) has caused kidney failure, heart attacks and strokes. These aprotinin lawsuits claim that Bayer, the drug’s manufacturer, marketed and sold Trasylol as a safe and effective medication to help prevent excessive bleeding during bypass surgery. They also claim that Bayer failed to adequately warn patients of its side effects.

Bayer disputes the growing number of aprotinin studies that show increased risk of serious complications and death in Trasylol recipients. The causal link between Trasylol and these potentially fatal side effects has been known for several years and there is evidence that Bayer has known about the link between Trasylol and kidney failure as far back as the early 1980's. The German scientist Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe incidents of kidney damage in animals that were given Trasylol more than 20 years ago. According to Dr. Fischer, he was surprised Bayer wasn’t interested in his findings.

For a free consultation and help finding out if you or a loved one was given Trasylol during their heart surgery please visit our Trasylol Lawsuit Center.

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In March 2008 the New England Journal of Medicine published an editorial – Learning from Aprotinin – Mandatory Trials of Comparative Efficacy and Safety Needed. They 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 side effects and the potentially fatal consequences that have affected tens of thousands of heart surgery patients are becoming more and more apparent.

Trasylol (aprotinin) was first approved by the FDA in 1993 to help in reducing 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?”

A vital piece of the drug approval and monitoring process that is missing, according to the editorial, is the requirement for more information on infrequent but serious complication and performance relative to alternative drugs. They state that the key 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.

For more information please visit our Trasylol class action lawsuit center.

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Bayer discontinued three Trasylol clinical studies which were set up to look at expanding the use of the drug. Trasylol is currently approved to help reduce blood loss in bypass heart surgery patients who are at a high risk of excessive bleeding and blood transfusion.

The clinical trials for Trasylol were set up to explore the safety and efficacy of Trasylol in areas such as spinal-fusion surgery, pneumonectomy, esophagectomy for cancer, and total cystectomy for cancer.

Bayer stated they halted the studies following an FDA Trasylol labeling change that Trasylol should only be used in certain surgical procedures with patients who are at an increased risk for blood loss and blood transfusion and where cardiopulmonary bypass is available. Bayer maintains that the Trasylol studies were not terminated for safety reasons.
According to Dr. Steven Galson, the Director of FDA's Center for Drug Evaluation and Research, "The purpose of the label change is to inform physicians and patients about the risks associated with Trasylol and to ensure they understand the new warnings and use the product as directed by the label."

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