Trasylol – An Overview

Trasylol is commonly used in heart surgeries to restrain blood loss. According to a study published in the New England Journal of Medicine in 2006, use of Trasylol during bypass surgery doubles the risk of heart attack, kidney failure, stroke and death. Bayer, manufacturer of Trasylol claimed that 2006 was not conducted properly. The U.S. Food and Drug Administration asked the doctors to monitor the patients taking Trasylol.

A Canadian study established that the use of Trasylol during heart surgeries increases the death rate among patients. After this study in November 2007, Bayer A.G. manufacturer of Trasylol declared to withdraw this drug from the market.  FDA asked the manufacturers to withdraw the drug in phases so that alternative medicines are available.

Trasylol – An Insight into the History

Aprotinin, commonly known as Trasylol is used for decreasing the bleeding during surgical procedures like liver and heart surgeries. Use of this drug during surgeries slows down fibrinolysis, a process of breaking down blood clots. It prevents organ damage by averting a fall in blood pressure. Further, it reduces the requirement for blood transfusion, especially during major surgeries.

Although, Aprotinin was available in the market as early as 1960s, it was not used widely until recently. Towards the end of 1980s, Bayer Corporation patented and aggressively marketed Trasylol. Initially it was used fro the treatment of acute pancreatitis. Acute pancreatitis is a condition in which its own enzymes destruct the gland and it is believed to be a part of pathogenesis. Until late 1960s, it was not used in major surgeries where blood loss was considered as a major problem.

Bayer focused on the development and research of Aprotinin. Bayer wanted to replace aminocaproic acid, a commonly used anti-fibrinolytic medicine widely used by doctors to control post – operative bleeding. Generally, patients undergoing complex surgeries, needed blood transfusions, sustained major blood loss or bleeding have been recommended aminocaproic acid. Major risk for the patients getting aminocaproic acid was not related to the drug’s interaction with patient but was from thrombosis. The results of this reaction are sometimes life threatening including heart attack, kidney failure or stroke.  However, in healthy patients, the risk for fatalities is less than 5 percent. This is not only due to the advance s in medical community but also due to the knowledge, practical application and research of medicines.

Through aggressive marketing and dubious politics, Trasylol was widely used by surgeons for liver and open-heart surgeries. This resulted into the huge profits for its manufacturer, Bayer. In 2005, this drug was sold for $ 300 million while in 2006, its sale hit $750 million. Although, it was a flagship drug but it monopolized the anti-proteolytic and anti-fibrinolytic market share. Recently, it has been found that Bayer, manufacturer of Trasylol was aware of the severe complications and risks associated with Trasylol. This life threatening risk was higher in the patients receiving Trasylol during surgeries. Studies conducted on Trasylol established that it might cause heart attack, kidney failure, stroke or even death.

It is now a known fact that the life threatening risks of Trasylol were known as early as 1980s. Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found that the animals given Trasylol suffered from severe kidney damage. When he released the results of this study to Bayer, they neglected the serious risks of Trasylol. Shortly, patients given this drug showed similar side effects. As Canadian Government was worried about the increasing mortality rate among the patients receiving Trasylol, it commissioned a study to check the hypothesis that Trasylol was better in reducing bleeding during liver and heart surgeries. No sooner did this study begin it was stopped because there was a risk of death among the patients receiving Trasylol as compared to the patients receiving other drugs.  Under the pressure of the Canadian Government and the U.S. Food and Drug Administration, Bayer suspended Trasylol temporarily from the market.

Approximately, 4.5 million people were given Trasylol around the world. Of these 4.5 million people, one- third belonged to the United States alone. If this drug would have been withdrawn from the market at the right time then about 22,000 lives could have been saved.

Trasylol Causes

On February 17, 2008, a television program “60 minutes” reported a segment on the prescription drug Aprotinin, manufactured by Bayer under the brand name Trasylol. It showed a fourteen year history of this drug, an antagonistic marketing campaign during the early years of the drug’s introduction to the market.

Since 1980s, concerns regarding the life threatening side effects of Trasylol have been discussed. Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, discovered serious incidences of kidney damage among the animals given Trasylol. When he reported the results of this study to Bayer’s, manufacturer of the drug, they denied the information, thus neglecting fatal side effects of Trasylol. Shortly, patients given this drug showed similar reactions. One of the most common side effects associated with the use of Trasylol was complete renal failure, usually known as kidney failure. Dr. Nicholas Kouchoukos, one of the Americas top most heart surgeon conducted a small study on 20 patients. Out of these 20 patients, 23 patients showed problems with kidney after taking Trasylol. However, FDA overlooked the result of this study and many other studies and approved Trasylol for market use in 1993.

Through persistent market campaign and pressure on the Food and Drug Administration, Bayer manufactured the drug to be used in open heart surgeries and Trasylol was considered as a drug beneficial in controlling bleeding in other surgeries as well. Dr. Dennis Mangano, a prominent personality in the field of medical research, conducted a study on 5,065 patients taking Trasylol in 17 countries across the world. This study was published in the New England Journal of Medicine in January 2006. It was one of the largest and enlightening studies conducted on Trasylol. This study not only established the link between patients using Trasylol and renal failure but also suggested an increased tendency of deaths in the hospitals.

However, when Dr. Mangano presented the results of this study to the FDA advisory committee, their response was less or not at all proactive to that of what he imagined. As Dr. Mangano’s study was conducted on the patients in the hospital rather than a traditional study involving placebo, FDA advisory committee was uncertain to fulfill his request of withdrawing the drug from the market. Dr. Alexander Walker, a professor at the Harvard University, conducted a study examining 70,000 patients. This study was similar to the study conducted by Dr. Mangano. Dr. Alexander’s study also found that patients taking Trasylol were at an increased risk of developing kidney failure and death. However, Bayer failed to inform the advisory committee about the confirmed results of the two studies .This forced Dr. Walker to directly contact FDA. However, FDA did nothing and only issued warning letter to the doctors.

In 2007, a clinical study conducted in Canada was stopped in between when the participants in the study started dying. The German Government instantly withdrew and banned Trasylol through an effort between the Food and Drug Administration and Canadian government.

It is assumed that about 4.5 million patients have been prescribed Trasylol across the world. Of these 4.5 million people, approximately 1.5 million patients were given this drug in the United States. According to Dr. Mangano, if between his study and the temporary suspension on the drug, the drug had been banned from the market, about 22,000 lives could have been saved.

If you believe that you are suffering from the side effects of Trasylol, contact an experienced attorney who will assist you in filing a lawsuit against the manufacturer.

Beware of the Fatal Side Effects of  Trasylol-Aprotinin Injection

Trasylol-Aprotinin is used to control postoperative bleeding in heart and liver surgeries. It is an injectable drug manufactured by Bayer A.G, a German Pharmaceutical conglomerate. This drug is used in more than 60 percent of heart surgeries. However, this drug decreases the health of heart patients, by increasing the risk of developing kidney failure demanding dialysis. Additionally, it also increases the risk of heart attack, stroke and even death. According to a study, it was found that the use of Trasylol –Aprotinin injection increases the risk foe kidney failure among the heart patients.

Shocking side effects

Although 10,000 is a huge no. but 110 or 181 percent is much higher. These are the percentages by which the Trasylol patients are at a risk of developing stroke or heart attack. Additionally, it has been proven that Trasylol doubles the risk of kidney failure among heart surgeries patients.

In January 2006, a study conducted by researchers at the Ischemic Research and Education Foundation in California, showed that replacing Trasylol with aminocaproic acid or tranexamic acid could not have only prevented 11,000 kidney problems a year, but could have also saved $ 200 million.

Until, March 2006, Bayer AG, marketed and defended one of its most dangerous drug, Trasylol. Currently, it is pushing to get the approved for the use in hip replacement surgery. Thus, broadening, the market fro the drug and exposing a larger no. of patients to the several side effects of the drug. Trasylol is ten times higher to its other counter parts

Legal Advice

If you believe that, you are suffering from the adverse side effects of Trasylol Aprotinin injection like renal failure, stroke, encephalopathy or heart problems, than immediately consult a doctor. Thereafter, you can contact an experienced pharmaceutical lawyer who will assist you in filing a lawsuit against the company. He will further help you in getting monetary compensation for lost wages, current and future medical expenses, medical bills and pain and suffering caused due to the severe side effects of Trasylol.