FDA public advisory on Bayer

German drugmaker Bayer has acknowledged that it "mistakenly did not inform the US Food and Drug Administration about a retrospective study commissioned by the company to analyze the effects of aprotinin, aminocaproic acid and tranexamic acid in patients undergoing coronary artery bypass graft surgery," noting that this data on aprotinin, brand named Trasylol, "was not shared immediately with the agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology."

Bayer's announcement follows an FDA Cardiovascular and Renal Drugs Division endorsement of Trasylol for the prevention of blood loss during surgery (Marketletter October 2), and the agency says it was not aware of the data at the time of the advisory panel meeting.

The German firm says it has submitted a copy of the preliminary report to the FDA and has notified other regulatory authorities. The company is now analyzing this study, answers received from the questions posed to the investigator and, additionally, will work with the investigator and other experts to examine the underlying source data and fully understand the results.