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Friday—October 13, Bayer AG suspended two senior employees over the company's failure to provide U.S. regulators with data on its heart-surgery drug Trasylol. Bayer also said it had hired an independent counsel to investigate its actions regarding the disclosure of the preliminary results from the Trasylol study.
While the FDA is conducting its study based on new Trasylol data, they recommend physicians who use Trasylol should carefully monitor patients for the occurrence of kidney, heart, or brain toxicity and promptly report observed adverse event information to the FDA MedWatch program. Physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks.
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)