German drugmaker Bayer AG has halted its sales of Trasylol (also known as aprotinin), an anti-bleeding drug which is supposed to reduce blood loss and allow patients undergoing heart-bypass surgery to avoid transfusions. Bayer is reported to have made the decision after talks with the U.S. Food and Drug Administration, the German Federal Institute for Drugs and Medicine Products along with Health Canada.
<"http://www.yourlawyer.com/topics/overview/trasylol">Trasylol has been under the scrutiny of the Food and Drug Administration (FDA) since early 2006 but has recently gotten more attention since a Canadian clinical trial was halted last month for concern of higher death risks. Evidence shows Trasylol may be linked to a higher risk of death than that of competing drugs, due to an increased risk of heart failure, kidney failure, hear attacks and strokes.
The FDA approved Trasylol in 1993. The drug has been tied to high-profile safety concerns since early 2006 when the New England Journal of Medicine published a study done on the drug in January 2006. The published study found the drug might be linked to a doubled risk of kidney failure, as well as increased risk of heart attacks, heart failure and strokes and advised that continued use of the drug â€œis not prudent.”
Another recently published study has suggested that patients receiving Trasylol may be at higher risk for kidney damage. This report (published January 20, 2006 in the on-line edition of Transfusion) used methods similar to those used in The New England Journal of Medicine study but included a smaller number of patients.
A further study suggested that Trasylol may increase the risk for clot formation within coronary artery bypass grafts. In this study, patients receiving Trasylol were compared to those receiving a placebo. The study reported an increased rate of bypass graft closure for patients receiving Trasylol.
More recent studies have suggested the drug also raises the risk of death. One of those studies previously was withheld by Bayer from the FDA due to what a company investigation later characterized as a “regrettable human error.”
In February 2006, the FDA issued a notice warning doctors to closely monitor patients on Trasylol. The FDA ordered a label change in December 2006 to warn those taking the drug of potential kidney damage risks. Last month, after a Canadian clinical trial stopped enrolling patients to take the drug because it appeared linked to a higher risk of death, the FDA said it was reviewing Trasylol.
Last week, the FDA admitted that evidence does suggest that Trasylol does propose a greater death risk than similar drugs. The U.S. government later requested Bayer suspend sales of the drug, despite the fact that the FDA recommended Trasylol stay on the market a month before.