On September 29, 2006 German-based Bayer acknowledged that it mistakenly did not inform the U.S. Food and Drug Administration about a retrospective study commissioned by the company to analyze the side effects of aprotinin, aminocaproic acid, and tranexamic acid in patients undergoing coronary artery bypass graft (CABG) surgery. This data was not shared immediately with the FDA because it was preliminary in nature and raised significant questions on the study population, outcomes, and methodology. Bayer has submitted a copy of the preliminary Trasylol report to the FDA and has notified other regulatory authorities. (Yahoo)