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Trasylol

Trasylol or aprotinin is a drug that is manufactured by Bayer. It comes from bovine lung tissue, and is used to reduce the risk of bleeding in patients during open heart surgery. Trasylol is often used when a patient is undergoing Coronary Artery Bypass Grafting (CABG) using cardiopulmonary bypass, because such patients have an increased risk of bleeding. Essentially, CABG is a common surgical procedure that brings blood to the heart.

Trasylol Risks

The New England Journal of Medicine reported in November 2006, that a study of 4,374 patients who had CABG surgery and were given Trasylol had an increased risk of renal (kidney) failure, myocardial infarction (heart attack), and stroke, than patients who received no medications reducing the chance of bleeding, or received other medications reducing the risk of blood loss.

Another study reported that there were higher incidents of decreased kidney function in patients who received Trasylol, compared to other patients who received different drugs that reduced the risk of bleeding.

FDA's Response

As a result of these findings, the Food and Drug Administration evaluated the studies regarding aprotinin and the data it originally received from Bayer regarding aprotinin and its risks. On February 8, 2006, the FDA issued a Public Health Advisory notifying patients and doctors who perform heart bypass surgery that Trasylol has been linked to higher risks of kidney damage, heart attacks, and strokes. The FDA advised doctors to monitor patients to detect toxicity to the kidneys and heart, and to consider limiting Trasylol to situations where reducing the risk of blood loss was essential and outweighed potential risks.

Manufacturer's Removal of Trasylol

A Canadian study, which published its findings in 2008, indicated that Trasylol increased the risk of death, as compared to other drugs that were used to decrease the risk of bleeding. Prompted by this study, Bayer HealthCare Pharmaceuticals Inc., with the FDA's approval, began removing Trasylol stock from the U.S. market.

Presently, the FDA and Bayer has agreed to limit the use of Trasylol to an investigational use, where it can be used in patients who have an increased risk of blood loss during CABG surgery and who have no other alternatives to using Trasylol. Doctors must also establish that the benefits of Trasylol outweigh the risks.

For information and current updates regarding Trasylol by the FDA, please click this link.

If you or someone you know has received Trasylol during open heart surgery, and has experienced kidney damage, heart problems, and stroke; or you have lost a loved one who used Trasylol, contact Anderson Law Offices, LLC for a free consultation.

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