Patients Taking Trasylol^® Doubled Their Risk of Kidney Failure

What Heart Surgery Patients Should Know About Aprotinin or Trasylol^® Side Effects

Trasylol (aprotinin) is used to minimize bleeding during heart bypass surgery. However, the drug may cause serious kidney problems, including kidney failure that requires dialysis. Trasylol may also greatly increase the risk for strokes and heart attacks. Some patients have severe or life–threatening allergic reactions to Trasylol, including shock, impaired breathing, and sudden heart failure.

Doctors have often prescribed Trasylol for their heart surgery patients, despite its unwelcome side effects. If you are about to undergo surgery, you should be sure to let your doctor know if you have taken Trasylol or aprotinin before, as prior exposure to the drug can make you more susceptible to an allergic reaction. The FDA requires that a patient not take Trasylol more than once in a 12–month period; otherwise he or she has a high risk of developing a fatal allergic reaction.

Before taking Trasylol, tell your doctor about any kidney problems that you have had. If you or a family member had heart bypass surgery and developed kidney failure or suffered a heart attack or stroke, you should find out whether the physician had prescribed Trasylol.

We are presenting this guide to provide you with background and resources about Trasylol. We hope the information will help you discuss the medication with your doctor. Please feel free to contact us for more details about Trasylol and to find out about your legal rights if you have been injured by Trasylol.

What is Trasylol?

Trasylol is the brand name for aprotinin, a protein product produced from the lung tissues of cows. Given by injection, Trasylol stops or slows certain enzymes that normally promote bleeding. As a result, Trasylol decreases bleeding and the need for blood transfusions during surgery.

What Does the FDA Say About Trasylol or Aprotinin?

In 1993, the Food and Drug Administration (FDA) approved the use of aprotinin for heart bypass patients. At that time, the agency warned that the medication should be reserved for high risk patients because of the danger of severe allergic reactions (FDA News, December 30, 1993). It also noted that kidney toxicity could be an aprotinin side effect in some patients.

The FDA gave Bayer the go–ahead to market an injectable form of aprotinin under the name Trasylol in August 1998. Over seven years later, the agency issued a health advisory warning about the association between Trasylol and heart attacks, strokes, and kidney failure. Doctors should only prescribe Trasylol if a patient is at increased risk for blood loss and transfusion and must undergo heart bypass graft surgery and use a heart pump during the operation. The FDA also told doctors to carefully monitor these patients for kidney problems.

How Great Is the Risk of Developing Kidney or Heart Failure from Trasylol or Aprotinin?

Heart bypass surgery patients who were given Trasylol doubled their risk of kidney failure requiring dialysis compared to patients who did not take medicines to reduce blood loss, according to an observational study of 4,374 patients (N Engl J Med. 2006 Jan 26; 354(4): 353–65). In addition, their risk of heart attacks or heart failure increased by 55 percent.

Patients who received aminocaproic acid or tranexamic acid did not increase their chances of developing kidney or heart problems. These are generic, less expensive medications used to reduce bleeding during heart surgery. The researchers concluded that “continued use [of aprotinin or Trasylol] is not prudent,” and called the other medications safe alternatives. Another study confirmed the link between aprotinin and kidney failure and showed that there were no harmful kidney side effects with tranexamic acid (Transfusion 2006 Mar;46(3): 327–38).

How Can I Find Out More About Trasylol?

For more details about Trasylol, see Information for Health Care Professionals on the FDA web site. The web site also includes the complete prescribing instructions for the medication. You will need Adobe Acrobat Reader to open the file containing the prescribing instructions. If you do not have this software, you may download a free copy on the Adobe Acrobat web site.

Do I Have a Case Against Trasylol’s Manufacturer?

Brayton Purcell is now evaluating cases of Trasylol or aprotinin users who have had kidney failures, heart attacks or strokes. If you or a family member developed these conditions while taking Trasylol during heart bypass surgery, please contact us through this web site or call 1–866–809–5240 toll–free.