Heart Surgery Drug Recalled Due to Kidney Failures & Heart Attacks

On November 5, 2007, 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.