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

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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Many people are wondering if there is a Trasylol class action lawsuit against Bayer Pharmaceuticals. Currently Trasylol lawsuits are being filed by individuals and families throughout the United States. No class actions have been filed, however given the number of potential Trasylol victims, attorneys and courts will likely look to multidistrict litigation and class actions to more efficiently handle the growing number of cases. The potential number of patients suffering from side effects such as aprotinin kidney failure, stroke and heart attacks is staggering.

According to Dr. Dennis Mangano, around 431,000 patients received aprotinin between the time his Trasylol study was published and the time Bayer withdrew the drug from the market. He estimates that approximately 1,000 lives per month could have been saved if Trasylol had been pulled more quickly. This is during a relatively short period of time considering how long the drug has been on the market.

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On Sunday, February 17, the lead story on 60 Minutes was Bayer's heart surgery drug Trasylol. Kidney failure and heart attacks are the two main side effects associated with Trasylol according to the 2006 study by medical researcher Dr. Dennis Mangano. His observational study included over 5000 patients in 17 countries. Dr. Mangano told 60 Minutes' correspondent Scott Pelley that "[I]t showed an important association between Trasylol use and kidney failure requiring dialysis and it showed a trend toward increased death in hospital in these patients."

The story also profiled the Trasylol patient Joe Randone. He went in for heart valve replacement surgery at the age of 52. Following surgery where Trasylol was put in Mr. Randone's IV, he suffered two heart attacks and kidney failure. Over an eight month period of time he had 19 operations. In August 2006 Mr. Randone died from complications. The family has filed a Trasylol lawsuit against Bayer. Dr. Mangano estimated that 1000 lives per month could have been saved if the drug had been taken off the market after his Trasylol study was published.

Pelley also interviewed Dr. William Hiatt, the chair of the FDA's advisory committee that was presented with the Mangano study in 2006. Dr. Hiatt stated that Bayer did not disclose their own study which confirmed Dr. Mangano's findings and Hiatt's FDA committee voted to keep Trasylol on the market. The following week the author of the Bayer study, Alexander Walker, blew the whistle on Bayer and presented the study to the FDA.

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