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Tuteur & Associates, LLC | Knowledge is Power.
September 29, 2006
Leverkusen – Bayer acknowledged today that it mistakenly did not inform the U.S. 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 (CABG) surgery. This data 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 believes that despite the highly preliminary nature of this data, the information should have been shared with the FDA prior to the September 21st Advisory Committee meeting held to assess the safety and efficacy of Trasylol. This was a mistake on the company’s part. Continue reading, ‘09-29-2006 | Bayer Acknowledges That New Trasylol Study Was Not Disclosed Prior to Recent FDA Cardio-Renal Advisory Committee.’