Bayer Suspends Sales of Trasylol.

The U.S. Food and Drug Administration (FDA) today announced that, at the agency’s request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. This Trasylol recall or marketing suspension follows two scientific studies confirming the serious dangers of the drug. The initial study, which was the largest worldwide Trasylol study ever conducted, was performed by Dr. Dennis Mangano, the same physician who warned the FDA two years ago about the serious side effects of Trasylol.

According to the Wall Street Journal, Bayer said its decision came in the wake of requests or orders from regulators in the U.S., Canada, Germany and other countries. Trasylol, which is supposed to reduce blood loss and allow patients undergoing heart-bypass surgery to avoid transfusions, is the third drug this year whose sale in the U.S. has been halted under scrutiny from the Food and Drug Administration, a signal of how the agency is weighing safety issues heavily in drug decisions.

Still, the history of Trasylol, which was approved in the U.S. in 1993 and has been tied to high-profile safety concerns at least since early 2006, is likely to draw questions from Congress and plaintiff attorneys. It took the FDA eight months to initiate the widespread recall after the physicians’ warnings. These delays in action have been estimated to cause the death of 1,000 patients each month. Bayer has been accused of withholding negative reports about Trasylol from the FDA in order to maintain profits.

On November 5, 2007 the FDA requested Bayer Pharmaceuticals Corp to suspend the further sale or use of the antibleeding drug called Trasylol, amid growing concerns and strong medical evidence that Trasylol may be linked to a higher risk of kidney and renal failures, heart attacks, stroke and death than other antibleeding drugs used during a cardiac bypass, heart catherization or other cardiac surgery or operations.

Trasylol (aprotinin), Bayer’s injectable drug used to prevent excessive blood loss during heart surgery, has produced distrubing results in a recent New England Journal of Medicine study. The New England Journal of Medicine, January 25, 2006, states that patients who were given Trasylol, compared with controls, had nearly double the risk of death, renal failure, or stroke and a more than 50% increased risk of heart attack. Trasylol also increases the risk of kidney damage and kidney failure. If you or a loved one have experienced complications after cardiopulmonary bypass (CPB) or coronary artery bypass graft surgery (CABG), or any serious surgery, you should contact your medical providers to determine if Trasylol was used during the procedure.

Speak to a Trasylol Lawyer

If you or a loved one has suffered a heart attack, heart damage, stroke or kidney failure after Trasylol was used during heart surgery, contact our law firm at once. It may be too late to recover from the debilitating effects of Trasylol, but an experienced product liability attorney can assist you in a legal action against the makers of Trasylol. You are not alone. Join other heart attack, heart damage, stroke and kidney failure victims in speaking up and fighting for their legal rights. You may be entitled to file a lawsuit for your pain and suffering, mental anguish, medical bills and other legal remedies and damages. Contact our law firm today.