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

As the results of more studies are published, the evidence is continuing to show the problem of Trasylol kidney failure following heart surgery. Patients and families around the country are filing Trasylol lawsuits as the public becomes more aware of Bayer’s heart surgery drug side effects. Trasylol has recently been linked to a higher risk of kidney damage, heart attack, and death in the five years following a patient undergoing bypass heart surgery.

In 2006 The New England Journal of Medicine (NEJM) published a study that reported Trasylol problems with an increased risk of developing heart failure, kidney damage, myocardial infarction, and stroke in bypass heart surgery patients. This study was followed by an increasing number of Trasylol studies that confirmed the findings of the 2006 NEJM study.

Trasylol studies increasingly show that the drug causes serious problems in bypass patients. In 1993 Trasylol, also referred to as “Aprotinin”, was approved by the Federal Drug Administration (FDA). Aprotinin is manufactured by Bayer under the brand name Trasylol. Over the past several years Trasylol sales continued to increase even though studies indicated serious Trasylol kidney damage side effects until late in 2007 when Bayer finally withdrew their heart surgery drug from the market.

Most bypass heart surgery patients are unsure if they were given Trasylol during their open surgery. Many patients suffering from Trasylol kidney failure or stroke side effects don't know if they were given Trasylol during their surgery because the surgeon made the decision whether to use the drug to help prevent excessive bleed loss during surgery.

Trasylol affects the way in which blood clots. It is given to open heart surgery patients to help prevent excessive bleeding. One of the most serious complications for bypass surgery patients is excessive bleeding. Clotting medications such as Trasylol reduced the amount of blood transfusion needed during surgery. Trasylol is primarily used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. The drug had been in use for 13 years and a million patients had received it before Bayer withdrew it from the market after growing evidence of serious side effects.

For the latest information and litigation news please visit our Trasylol lawsuit website.

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Patients and families across the United States have filed Trasylol lawsuits based on the devastating side effects of the drug. Currently no Trasylol class action suits have been filed and claims are being filed individually. The lawsuits claim that Bayer, the drug’s manufacturer, was negligent in multiple ways including:

• marketing and selling Trasylol as a safe and effective medication for heart surgery patients
• failing to adequately warn patients of unreasonable and dangerous side effects some of which were fatal
• failing to conduct adequate pre-clinical testing and post-marketing studies to determine the safety and side effects of Trasylol
• failing to use ordinary care in designing, testing and manufacturing Trasylol

Bayer’s Trasylol heart surgery side effects have recently been linked to an increased rate of kidney failure, heart attack, and death in the five years following a patient undergoing heart surgery.
In 1993, Trasylol (also referred to as “aprotinin”) received FDA approval for use in certain types of heart surgeries. Until recently, Trasylol was used to reduce the amount of blood a patient loses both during and after a surgery. However, a mounting controversy surrounded the continued use of Trasylol, and in February of 2006, the FDA issued a public health advisory warning physicians to limit use of Trasylol.

A recent study based on observations at 69 leading cardiac centers around the world was published regarding Bayer Pharmaceutical’s heart surgery drug Trasylol. Kidney failure, heart failure, and stroke are side effects associated with Trasylol heart surgery patients according to the study published by Mangano et al. in January 2006 in the New England Journal of Medicine (NEJM).

On September 21, 2006, the FDA met to investigate the dangers of Trasylol. Although Bayer appeared to cooperate with this FDA investigation, it was later learned that Bayer was withholding data from a study which revealed Trasylol causes serious and potentially deadly side-effects. The FDA learned that Bayer did not disclose this important data shortly after the FDA completed its investigation. However, the FDA learned about this data only because a scientist from Bayer’s study tipped off the FDA. Bayer failed to willingly disclose the data to the FDA even when Bayer representatives met with FDA officials to go over the dangers of Trasylol, and even though numerous FDA officials commented to Bayer that they needed more data. Following increasing studies showing the serious risks of Trasylol, Bayer finally removed Trasylol from the marketplace in November 2007.

Most heart surgery patients don't know if they were given Trasylol during their open heart surgery. Many patients suffering from Trasylol kidney damage side effects don't know if they were given Trasylol during their surgery because the surgeon made the decision whether to administer the drug to stop excessive bleeding during surgery.

For more information please visit our Trasylol lawsuit center.

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COLOGNE, Germany – Bayer’s CEO stated that Bayer AG is facing 78 Trasylol lawsuits in the United States as a result of its heart surgery drug. "We are not aware of any lawsuit outside the United States," Werner Wenning told a shareholders' meeting.

Trasylol affects the way in which blood clots. Prior to the drug’s removal from the market it was given to open bypass surgery patients to prevent excessive bleeding. Trasylol was mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. One of the most serious complications for bypass surgery patients is excessive bleeding. Clotting medications such as Trasylol reduced the amount of blood transfusion needed during surgery. In 2006 The New England Journal of Medicine (NEJM) published a study that reported Trasylol problems with an increased risk of developing heart failure, kidney damage, myocardial infarction, and stroke in bypass heart surgery patients.

Bayer withdrew their heart surgery drug Trasylol from the marketplace late in 2007 following a Canadian study that linked Trasylol with an increased risk of death and kidney failure. Bayer plans on defending Trasylol claims vigorously, however they are facing the potential of thousands of lawsuits from individuals and families throughout the country as more people discover that Trasylol was used during their heart surgery

For more information regarding a Trasylol lawsuit please call Fields Law Firm or e-mail us for a free confidential consultation. We are presently representing patients and families throughout the United States. We have additional information available at our national Trasylol lawsuit website.

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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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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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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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December 30, 1993 – Aprotinin (Trasylol) Receives FDA Approval
The Food and Drug Administration announces the approval of aprotinin, a drug used to control excess bleeding in bypass heart surgery patients.
The FDA stated that the use of Trasylol should be reserved for heart surgery patients with a high risk of excessive bleeding. During clinical trials kidney toxicity was reported as a problem in some patients.

January 20, 2006 – Trasylol Associated With Renal Toxicity
Karkouti, et al. publishes an article in the journal Transfusion suggesting a link between aprotinin and kidney problems among cardiopulmonary bypass patients.

January 26, 2006 – Risks Associated with Aprotinin in Cardiac Surgery
The New England Journal of Medicine publishes an article by Mangano et al. reporting an association of Trasylol (aprotinin injection) with serious kidney problems and heart attacks. The study found that patients who were given aprotinin were more than twice as likely to have kidney failure requiring dialysis, a 55% increase of heart failure and a 181% increase in stroke. The authors advised against further use of the drug, since safer, cheaper alternatives are available.

February 8, 2006 – FDA Public Health Advisory
Following two studies associating the use of Trasylol with increased risk of kidney failure, heart and central nervous problems after heart surgery, the FDA issued a public health advisory. The FDA recommended limiting Trasylol use to those situations where the clinical benefit of reduced blood loss outweighs the potential risks.

September 21, 2006 –Cardiovascular and Renal Drugs Advisory Committee
The FDA holds a public meeting to discuss the safety and overall risk-benefit profile for Trasylol. The committee supports acceptable safety and efficacy for Trasylol among coronary artery bypass graft (CABG) surgery patients.

September 27, 2006 – Additional Study Revealed by Bayer
Bayer Pharmaceuticals reveals to the FDA that it had conducted an additional Trasylol safety study. The study shows use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. The failure of Bayer to disclose the data from the additional study seriously undermined the advisory committee process and delayed the safety review.

September 29, 2006 – FDA Public Health Advisory
Federal Drug Administration announces that Bayer failed to disclose a Trasylol study prior to the September 21, 2006 public meeting held to discuss the safety of Trasylol (aprotinin). The FDA warns doctors who administer Trasylol to carefully monitor their patients for any adverse events, in particular, problems with the kidneys, brain or heart. Physicians treating Trasylol patients are also encouraged to report any Trasylol problems to the FDA or Bayer Pharmaceuticals.

October 13, 2006 – Bayer Suspends Employees Over Trasylol Study
Following the failure to reveal a Trasylol safety study, Bayer has suspended two employees in what seems like an attempt to justify why the study was not disclosed. The safety trial results focused on the potential Trasylol risks and side effects for patients using the drug during bypass heart surgery. The suspended Bayer employees are members of the Germany Drug Safety Group.
The Federal Drug Administration began reviewing Trasylol after two published studies associated the drug with serious side effects including kidney damage, heart attacks, and stroke.
The FDA panel had concluded that Trasylol was safe and effective but issued a warning on the product after reviewing the newly revealed data. Bayer stated that it had mistakenly failed to reveal the data because of its preliminary nature and did not attempt to knowingly withhold Trasylol study data from the panel.

December 15 2006 – FDA Revises Trasylol Labeling and Strengthens Safety Warnings
Following a review of safety information conduced by the Food and Drug Administration the Trasylol labeling was changed. The review, which started in January 2006, was prompted by Trasylol studies that showed an increased risk of kidney failure, heart attack and stroke in patients who were given Trasylol during heart surgery. The new labeling limits the drugs usage to specific situations where the patient has an increased risk for blood loss during surgery.

November 5 2007 – Bayer Withdraws Trasylol From the Marketplace
Bayer stopped selling the heart surgery drug Trasylol after studies linked the drug to a 50 percent higher risk of death than other drugs in the clinical trial. The FDA requested that Bayer withdraw Trasylol from the marketplace until further studies could be reviewed.

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On November 5, 2007 the Food and Drug Administration (FDA) announced that Bayer Pharmaceuticals Corp. has suspended the sale of Trasylol. Recall of this controversial drug at the request of the FDA was based on preliminary data from a Canadian study that compared heart surgery drugs used to prevent excessive bleeding.

The Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study was halted on October 19, 2007 due to the increased mortality in patients in the aprotinin (Trasylol) treatment group. The other anti-bleeding drugs in the study, aminocaproicacid and tranexamic acid, did not have the same increased risk of death compared to aprotinin. The study had planned to enroll around 3,000 adult Canadian patients who were going to have various types of cardiac surgery that put them in a high risk category for bleeding.

The FDA began taking a closer look at the safety of Trasylol in January 2006 after the publication of studies that linked the drug to dangerous side effects including heart attacks, kidney problems and strokes. In light of the initial BART study information, the FDA anticipates re-evaluating the risks and benefits of Trasylol. The FDA is working with Bayer to carefully phase Trasyol out of the marketplace in an attempt to prevent shortages of other drugs used prevent excessive bleeding during cardiac surgery.

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The latest Trasylol study which was published in the Journal of the American Medical Association reveals that the drug appears to increase the risk of dying by nearly 50 percent in the five years following heart surgery.

The international study tracked 3,876 heart bypass surgery patients in 62 medical centers around the world. Over five years, 20.8 percent of the Trasylol patients died compared to 12.7 percent of patients who did not receive an anti-bleeding drug. Adjusting for various factors, the researchers found that patients receiving Trasylol had a 48 percent increased risk of dying in the five years afterward.

The lead author of the study, Dr. Dennis Mangano, advises patients to discuss with their treating doctor what anti-bleeding drug they might be given during their heart surgery and the associated risks. Past patients should also look into whether they were given Trasylol so they and their doctors can monitor for any problems. "I believe that for the vast majority of coronary bypass patients the drug should not be used," Mangano stated.

The researchers said that replacing Trasylol (Aprotinin) with one of the other cheaper medications would prevent 10,000 deaths over a five year period. Bayer has stated it will "work with regulatory agencies and external experts in the field to further evaluate the findings."

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