Trasylol

You take the drugs your doctor prescribes in order to improve your health and well-being. But when a medication can cause death, serious damage, pain, and suffering, you should be informed about its problems and compensated for your losses. If you or a loved one has had complex surgery and may have been given Trasylol, you’ll want to know what you can do. Call us at the Monsour Law Firm. We will help.

Understanding Trasylol and its side effects

What is Trasylol?

What are the side effects of Trasylol?

Are there medications that can be used in place of Trasylol?

When were the problems with Trasylol revealed?

What should I do if I, or a loved one, have suffered from problems linked to Trasylol?

What is Trasylol?

Trasylol (aprotinin) is a medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery. Its main effect is the slowing down of fibrinolysis, a normal body process that keeps blood clots from forming. Trasylol has been prescribed to decrease the need for blood transfusions during surgery, as well as to prevent organ damage due to hypotension (low blood pressure) caused by significant blood loss. Often patients are not aware that they have been given Trasylol, since it is administered in conjunction with serious surgical procedures.

What are possible side effects of Trasylol?

Trasylol, used to control bleeding during heart surgery, has been linked with serious kidney damage, congestive heart failure, strokes, and death. On November 5, 2007, Bayer AG suspended worldwide sales of Trasylol following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.

A Canadian study showed that Trasylol increased the risk of death when used to prevent bleeding during heart surgery. Then, two studies were published in early 2008 comparing Trasylol (aprotinin) with aminocaproic acid, another medication which acts as an inhibitor of fibrinolysis. The studies found that usingTrasylol increased mortality by between 32% and 64%. One study found an increased risk in the need for dialysis and revascularization (the restoration of an adequate blood supply by means of a blood vessel graft).

Are there medications that can be used in place of Trasylol?

A study conducted by Canadian and Australian researchers, the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART), revealed that patients treated with Trasylol were 53 percent more likely to die than patients treated with similar drugs. The study compared Trasylol (aprotinin) with two other drugs, Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid). These safer drugs cost less than $50, while Trasylol cost over $1,000 and provided Bayer with significant profits.

When were the problems with Trasylol revealed?

The Trasylol story is, unfortunately, a tale of manufacturer deception and bureaucratic delay that has cost the lives and the health of many thousands of patients.

Problems with the drug first surfaced in the early 1980s. Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe kidney damage in animals given Trasylol. He reported his results to Bayer but the company showed no interest in his findings

When the FDA approved Trasylol in 1993, the research did show that Trasylol controlled bleeding. Some studies had indicated that problems might exist, but other studies did not, so the FDA noted that kidney toxicity might be a problem but still approved the drug for use. Critics maintain that Bayer never paid for any studies that were large enough to determine whether kidney failure was an substantial danger from the drug .

Bayer marketed the drug aggressively and in 1998, the FDA approved Trasylol for cardiac bypass patients. By 2005, the drug had $300 million in sales and was projecting sales of $750 million.

In early 2006, Dr. Dennis Mangano, a noted medical researcher, completed the largest Trasylol review ever conducted. Mangano’s study, which included 5,065 patients in 17 countries, showed an important association between Trasylol use and kidney failure requiring dialysis, as well as increased deaths. The FDA issued an advisory to doctors alerting them to Mangano's study. However, the FDA didn't plan to have a meeting about Trasylol for eight months.

On September 21, 2006, FDA held a public meeting to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the Mangano’s study and another study that reported an increase in the chance of kidney failure, heart attack and stroke in patients treated with Trasylol, compared to those treated with other similar drugs. The FDA also reviewed the Bayer worldwide safety review, and the FDA review of its own post-marketing database.

On September 27, six days after the FDA review, Dr Alexander Walker informed the FDA of a study Bayer had commissioned him to conduct to assess the safety of Trasylol. Bayer representatives had stood before the FDA committee less than a week earlier without revealing that this study existed. The new study analyzed existing hospital data from 67,000 records of patients undergoing coronary artery bypass graft surgery. 30,000 of the patients were treated with Trayslol and 37,000 were treated with alternate products. The report suggested that patients receiving Trasylol were at increased risk for death, kidney failure, congestive heart failure, and stroke.

The FDA reacted by issuing another warning to doctors. But the advisory committee would not meet again for a year to consider the results of Bayer’s hidden study.

In 2007, the Canadian government conducted a large clinical trial of Trasylol. The study had to be stopped because patients in the study group were dying. When the study was halted, Germany banned Trasylol, and the Canadians and, finally, the FDA persuaded Bayer to suspend marketing temporarily. Bayer, still refused to acknowledge the deadly consequences of using Trasylol and on its Web site stated that “Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling."

Since it was first marketed, more than four and a half million people had been given the Trasylol worldwide. Dr. Mangano, who conducted the study issued in early 2006, estimated that between his study and when the drug was taken off the market, there were approximately 431,000 patients who received the drug. In those two years alone, 22,000 lives could have been saved. After several more studies confirmed the deadly dangers of the drug, Trasylol was permanently recalled in May 2008.

What should I do if I, or a loved one, have suffered from problems linked to Trasylol?

If a loved one has died, or if you or someone in your family have suffered from problems linked to Trasylol you should consider seeking compensation for the damage Trasylol has done. The Monsour Law Firm is experienced and effective in Trasylol litigation. We will help you get the personal injury settlement you deserve.

Trasylol Lawsuits

The adverse effects from Trasylol are well documented. An experienced Monsour Law Firm attorney will prepare and prosecute your case to protect your rights and your future. In April 2008, Doug Monsour was appointed by United States Federal District Judge Don Middlebrooks of Southern District of Florida to serve on the Plaintiff’s Steering Committee of In re Trasylol Litigation. In this capacity, Doug has traveled across America, and to Europe, investigating the conduct of Bayer concerning Trasylol. He has been responsible for taking depositions of many of the most important Bayer executives in the litigation. We understand the issues.

Do you have a case?

The loss of your loved one is incalculable. The effects of Trasylol related kidney failure, heart attack, and stroke can have a devastating impact on every aspect of your life and the lives of your loved ones. The cost of treating Trasylol-related side effects and potential conditions is extremely expensive. Even if you have not contemplated litigation before, if you or your loved one has suffered because of taking the drug Trasylol, you should consider seeking compensation.

What are the next steps to take?

It is important to consult a personal injury attorney that is experienced in Trasylol litigation and has the skill and resources to get you the best possible results. The Monsour Law Firm will represent you with the diligence, determination, and knowledge you deserve. We can help.