Bayer Suspends Anti-Bleeding Drug Trasylol Amid Evidence of Higher Risk of Death

Article in the Wall Street Journal — Bayer Suspends Sales of Trasylol, by Anna Wilde Mathews.  Here’s an excerpt:

Bayer AG said it was suspending sales of its antibleeding drug Trasylol world-wide after requests from regulators, amid growing evidence that the drug may be linked to a higher risk of death than that of competing drugs.

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.

The drug had world-wide sales of £230 million ($338 million) in 2005. Sales dropped by about a third last year.

BGS