On November 5th, 2007 Bayer AG pulled worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, following a request from the U.S. FDA to remove the drug from the American market for safety reasons. The antibleeding drug was pulled after a study has shown there may be an increased risk of death from usage. The drug is used during heart bypass surgery. Trasylol, also known as aprotinin, works by blocking enzymes that dissolve blood clots. Trasylol had a 50 percent increased risk of dying compared with patients receiving the other drugs.

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The FDA panel had met last month to discuss the drug but was advised to keep the drug on the market. Possible side effects from Trasylol include heart attack, stroke, and kidney problems.

On December 15, 2006, Trasylol was given a BLACK BOX WARNING.

"Studies have found that Trasylol can increase the risk of kidney damage compared with other drugs," Dr. Gerald Dal Pan, the FDA's director of the Office of Surveillance and Epidemiology, said during the news conference.

Since January 2006, the FDA has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies; one 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, and the other that reported an increase in kidney dysfunction compared to another drug. On September 21, 2006, in a meeting held by the FDA with the Cardiovascular and Renal Drugs Advisory Committee, the findings from the two published observational studies were discussed to determine the safety of the drug.

If you were given Trasylol in an open heart or bypass surgery, and developed kidney failure, heart attack or stroke within 3 months after surgery CONTACT US NOW.

Trasylol is made from the lung tissue of cattle. It works to slow or prevent bleeding, and is used to reduce blood loss and the need for blood transfusion during some types of heart surgeries.

A drug commonly used to prevent excessive bleeding in heart surgery patients can greatly increase risk of kidney failure, a new international study found.

The FDA approved Trasylol in 1993 to control bleeding in patients undergoing open heart surgery and minimize the need for blood transfusions. The drug works by blocking enzymes that dissolve blood clots.

Heart bypass patients who were injected with Trasylol during surgery had double the risk of kidney failure and an increased risk of heart problems compared to those who got other drugs, researchers reported in Thursday's New England Journal of Medicine.

"Our findings raise serious concerns regarding the safety of an approved drug intended to limit blood loss in at-risk patients undergoing surgery," wrote Dr. Dennis Mangano of the Ischemia Research and Education Foundation, which led the study.

Trasylol's maker, Germany-based Bayer AG, insists the drug is safe based on its own experiments, but said it alerted regulatory authorities in the United States, Canada, Australia and Europe about the latest research.

Patients who took Trasylol had twice the risk of developing kidney failure that required dialysis and a 55% increased risk of a heart attack or heart failure. In contrast, those who took one of the two cheaper generic clotting medications had no harmful side effects.

Bayer Suspends Sales of Trasylol :: Read Article

Heart Surgery Followed by Kidney Failure, Stroke or Heart Attack: The Impact of Bayer's Trasylol® :: Read Article

If you have taken Trasylol and have suffered any of these problems, contact us today!