TRASYLOL

Trasylol (Aprotinin) is a serine protease inhibitor obtained from bovine (cow) lung or pancrease and is used to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass (CPB) in the course of coronary artery bypass graft surgery (CABG).

Trasylol was first approved for use in 1993 and became extremely profitable for Bayer. Sales of the drug hit $300 million in 2005, and higher until its recall. In many cases, patients were charged over $1,000 for Trasylol while other equally effective drugs without the same risks cost only $50.

On February 17, 2008, 60 Minutes aired a story on Traysol. In that Story it showed that Bayer was aware for decades of safety concerns with Trasylol and since 2006 was aware of widespread deaths associated with the use of the drug. It is estimated Trasylol contributed to the death of one thousand patients a month until its recall.

The 60 Minutes story further reported that Bayer conducted its own internal study to evaluate the risk of patient deaths from Trasylol. A Harvard professor was hired by Bayer to examine the medical records of nearly 70,000 patients. Patients on Trasylol were found to have an elevated risk of death and acute renal (kidney) failure.

The United States Food and Drug Administration (FDA) issued a Trasylol public health advisory on February 8, 2006. The advisory stated that the FDA was conducting a safety evaluation for Trasylol to assess the drug’s risks. Doctors were warned to carefully weigh the potential benefits and risks of Trasylol before administering the drug to patients. Patients who took Trasylol should be monitored for toxicity to the kidneys, heart, and central nervous system.

Bayer did not reveal this study to the FDA during its safety review of Trasylol in 2006. Shockingly, Bayer successfully lobbied the FDA to keep Trasylol on the market.

In November 2007, the U.S. Food and Drug Administration requested that Bayer withdraw the drug Trasylol from the market because of safety concerns. The drug was administered to as many as one-third of all patients undergoing cardiac bypass surgery.  

At the time Trasylol was initially withdrawn from the market, Bayer claimed the recall was merely a temporary suspension of sales. "Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling," the company stated in a press release.  

On May 14, 2008 Bayer officially pulled remaining supplies of Trasylol, a blood clotting drug used during heart surgery to control bleeding, from the U.S. market after a major study published in the New England Journal of Medicine found Trasylol significantly raised the risk of death compared to competing products.

Studies have linked Trasylol to an increased risk of kidney damage, heart attacks, and strokes. If you or a loved one have experienced complications after cardiopulmonary bypass (CPB) or coronary artery bypass graft surgery (CABG) you should contact your medical providers to determine if Trasylol was used during the procedure.

If you or a loved one suffered an injury caused by Trasylol, you may be entitled to sue the manufacturer. You may be legally entitled to recover medical expenses, lost earnings, as well as compensation for physical pain and suffering, mental anguish and physical impairment. For persons who have died, their surviving spouse or other family members often can bring a wrongful death action.

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