Fresh Guidelines to Physicians on Trasylol : Bayer

Bayer AG, one of the world’s leading healthcare and medical product manufacturer on Thursday issued fresh guidelines to physicians for its anti-clotting drug Trasylol, after BART Executive Committee halted its Canadian trial over concerns of increased mortality risk.

The drug used to prevent massive bleeding during coronary bypass surgery was approved by the U.S. Food and Drug Administration in 1993.

Generically as aprotinin, Trasylol, has been under medical scanner for over a year after hospital data suggested an inflated risk of death, serious kidney damage, congestive heart failure and stroke among people who received it.

Guidance from Bayer includes a recommendation urging "that physicians use Trasylol only in accordance with approved product labeling."

Furthermore, the U.S. Food and Drug Administration also posted a statement stating "the agency will consider the new evidence as part of its ongoing deliberations on whether the drug should be removed from the market or have additional warnings on its label."

As FDA anticipates re-evaluation of the overall risks and benefits of the anti-clotting drug Trasylol, "this re-evaluation may result in the need to revise the labeling or other regulatory actions. Until this process has been completed, health-care providers who are considering use of Trasylol should be aware of the risks and benefits described in the labeling for Trasylol and the accumulating data suggesting Trasylol administration increases the risk for death compared to other antifibrinolytic drugs," the US drug regulator emphasized.

However, the German manufacturer of the drug still believes that the drug is a "safe and effective treatment option for physicians" and is working in cohesion with FDA and health authorities only to "check if additional label for the drug are required".

To recall, Trasylol’s labeling was re-evaluated in January 2006 amid concerns of serious side effects including kidney damage and cardiac arrest were linked to the drug’s use.