On November 5, 2007, Bayer AG, the manufacturer of Trasylol, suspended sale of the antibleeding drug from the U.S. market. The suspension came amid findings from a Canadian clinical trial that appear to link Trasylol to an increased risk of death as compared to the risk from other drugs.

Trasylol was approved by the United States Food and Drug Administration (FDA) in 1993 to reduce blood loss and allow patients undergoing heart-bypass surgery to avoid transfusions.

Trasylol has been tied to high-profile safety concerns since early 2006:

• In January 2006, the New England Journal of Medicine published a study that found Trasylol might be linked to a double risk of kidney failure, as well as increased risk of heart attacks, heart failure, and strokes. The study concluded that two generic medications, adminocaproic acid and tranexamic acid, were significantly safer and just as effective as Trasylol.
• In February 2006, the FDA urged doctors to closely monitor patients taking the drug.
• In September 2006, an agency advisory committee voted unanimously to keep Trasylol on the U.S. market. Some doctors argued that Trasylol filled an important niche for patients who could not handle blood transfusions.
• In December 2006, the FDA made updates to Trasylol’s label to include warnings about potential kidney damage and a narrowing of the recommended population of patients.
• In February 2007, a follow-up to the New England Journal of Medicine study was published in the Journal of the American Medical Association. The follow-up study tied Trasylol to mortality risk.
• In September 2007, another advisory committee suggested Trasylol may be tied to a higher risk of death and kidney damage.

Bayer’s announcement it will suspend sale of Trasylol in the U.S. market is temporary, the company noted, until final results from the Canadian trial are compiled and completely evaluated. At this time, there has been no official FDA recall of the drug.

“Once the complete…dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol,” said a Bayer AG representative. “At that time the temporary marketing suspension will be reevaluated.”

Source: Anne Wilde Matthews, “Bayer Halts U.S. Sale of Trasylol,” Wall Street Journal, November 5, 2007; Natasha T. Metzler and Matt Moore, “Bayer Stops Sales of Trasylol Globally,” Associated Press, November 5, 2007.