Trasylol endorsed by FDA in CABG surgery

German drugmaker Bayer AG says that Trasylol (aprotinin injection), its product for the prevention of blood loss during surgery, has been strongly endorsed by the Cardiovascular and Renal Drugs Division of the US Food and Drug Administration. The announcement followed the Leverkusen-headquartered firm's participation in an open forum scientific session with the FDA, in which the drug's risk benefit profile was discussed.

Earlier this year, the FDA issued a Public Health Advisory alert informing physicians and patients that the drug has been linked to an increased risk of serious side effects, including kidney problems, heart attack and stroke, in patients undergoing artery bypass graft surgery (Marketletter February 20). Bayer said that the FDA panel endorsed use of the drug by 18 votes to zero with one abstention.

Additionally, the firm revealed that it has begun discussions with the FDA regarding: a potential update to the drug's indication that specifies that it should be used in patients at increased risk of blood loss and blood transfusion; revised guidance on elevated serum creatine levels and hypersensitivity reactions; and measures that the company could implement to further increase safety, such as administration of a test dose and possible development of a serological test to determine previous exposure to the agent.