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

On November 5, 2007, Bayer agreed to a Trasylol recall or as it was announced by the Food and Drug Administration, a “marketing suspension” of its heart surgery drug which has been associated with serious risks such as kidney failure, heart problems and death. Trasylol is a drug that was designed to control bleeding during heart surgery. Two weeks before the FDA’s announcement, researchers from the Ottawa Health Institute notified the FDA that they had stopped a study on Trasylol because it appeared to increase the risk of death for patients, compared to two other drugs used in the study.

Dr. Dennis Mangano, a medical researcher had published a revealing study in the New England Journal of Medicine in January 2006 prior to the Trasylol recall. His study showed that patients who had been given Trasylol had twice the rate of kidney failure and an increased risk of strokes, heart attacks and encephalopathy (a type of brain disease).

After the Trasylol recall, two studies published on February 28, 2008 in the New England Journal of Medicine confirmed that bypass patients who were given Trasylol had an increased risk of death. The release of these studies follows an interview of Dr. Dennis Mangano on the TV show 60 Minutes. Dr. Mangano stated that in his opinion the FDA should have pulled Trasylol from the market after his study was released in January 2006. It is estimated that approximately 413,000 patients received Trasylol between the time of his study and the time of the recall. According to Dr. Mangano, 22,000 lives could have been saved if the drug had been taken off the market in January 2006.

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Trasylol, an expensive medication given to heart surgery bypass patients during their surgical procedure to help prevent excessive bleeding may have caused staggering numbers of heart failure, kidney failure and strokes. Patients undergoing cardiac surgery were unaware that Trasylol, a medication manufactured by Bayer, has been found in clinical studies to lead to greater risk of death, stroke, and acute kidney failure.

If a patient was found by their surgeon to be at risk of excessive bleeding during surgery the patient had no way of knowing Trasylol had been found to be not only dangerous but extremely expensive compared to the generic alternatives.

Trasylol Bypass Surgery Alternative Drugs Available

A New England Journal of Medicine study reported that two other generic medications were available that are safer and less expensive than Trasylol.
Heart surgery medications that help prevent excessive bleeding during surgery:

• Trasylol cost per dose is $1,300
• The generic aminocaproic acid cost per dose is $11
• The generic tranexamic acid cost per dose is $44

The generic heart surgery drugs were revealed to be far less costly with no increased risk of heart attack, stroke or kidney failure.

For more information, please visit our Trasylol class action lawsuit website.

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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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On Sunday, February 17, 2008, the CBS news show 60 Minutes, featured a story concerning the serious side effects from Bayer's heart surgery drug called Trasylol. According to the 2006 study by medical researcher Dr. Dennis Mangano, the most serious and common complications associated with Trasylol were increased incidents of renal and kidney failure and heart attacks. His observational study included over 5000 patients around the world. When asked about his Trasylol study, Dr. Mangano told 60 Minutes' that, "It showed an important association between Trasylol use and kidney failure requiring dialysis and it showed a trend towards increased death in hospitals in these patients."

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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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Following the Trasylol study Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) published in the May 14, 2008online issue of The New England Journal of Medicine study, Bayer decided to remove the remaining supplies of Trasylol from hospitals. This is the latest in a growing number of studies showing the dangers of Trasylol. In November 2007, Bayer agreed to suspend marketing their heart surgery drug Trasylol (aprotinin) after preliminary results from a Canadian study that revealed an increased risk of death for patients given Trasylol during bypass surgery.

Trasylol has been used by patients throughout the world during heart bypass surgery to reduce bleeding. Trasylol is an expensive drug costing $1200 to $1500 compared to cheaper and safer alternative drugs which cost around $150. The BART study was merely the latest study that have shown evidence of Trasylol increasing the risk of serious side effects like kidney failure, stroke and death. For more information please visit our Trasylol Lawsuit Center.

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Another study reveals an increased risk of significant Trasylol side effects leading to a higher mortality rate in aprotinin recipients. A recent study published in The New England Journal of Medicine on February 21, 2008 shows an increased risk of death for patients receiving aprotinin (Trasylol) during coronary-artery bypass grafting (CABG). The researchers analyzed hospital data from over 33,000 heart surgery patients who received Trasylol and around 45,000 patients who received aminocaproic acid.

The study looked at hospital records with operating-room charges that included charges for either Trasylol (33517 patients) or aminocaproic acid (44,682 patients). Patients In patients receiving Trasylol during their heart surgery there was a 64% increased risk of death. The researchers concluded that physicians should weigh the benefits of Trasylol with the increased risk of death considering aprotinin showed little or not benefit in reducing the number of blood transfusions compared to the alternative drug aminocaproic acid. The researchers have provided the study data to the FDA and the manufacturer (Bayer); however Bayer has disagreed with the methods and conclusions of the study.

Study: Aprotinin during Coronary-Artery Bypass Grafting and Risk of Death
N Engl J Med 2008;358:771-83

For more information regarding a free consultation please visit our Trasylol 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 February 8, 2008, the American Journal of Nephrology published a study of aprotinin and kidney failure. Aprotinin is marketed as “Trasylol” by the drug company Bayer. This is the first aprotinin study to evaluate the effect of the drug on urinary NGAL (neutrophil gelatinase-associated lipocalin). Urinary NGAL increases dramatically following kidney damage.

In this observational study 369 patients undergoing heart surgery were either given aprotinin or aminocraproic acid during surgery. 205 patients received aprotinin and 164 received aminocaproic acid. The study found that the patients who were given aprotinin (Trasylol) during their surgery had a twofold higher risk of developing kidney failure compared to the patient group receiving aminocaproic acid. 25% of the patients receiving aprotinin (51 of the 205 patients) developed kidney failure. The results of this study confirm the results of Dr. Mangano’s earlier Trasylol study which revealed that patients who received the aprotinin had around a 50 percent increased risk of dying.

Study: Increased Incidence of Acute Kidney Injury with Aprotinin Use during Cardiac Surgery Detected with Urinary NGAL

Am J Nephrol 2008;28:576-582

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