FDA Statement Regarding New Trasylol Data
October 1, 2006 14:31

Since January 2006, the FDA has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: One study reported an increase in the chance of kidney failure, heart attack, and stroke... (Read Article)

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 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)

On September 29, 2006, as reported in Yahoo, 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 effects of aprotinin, aminocaproic acid,... (Read Article)

Failure by the German pharmaceutical giant Bayer to inform the Food and Drug Administration of the disquieting results of a large observational study cannot be easily dismissed with an apology. Circumstances suggest that Bayer sought to hide the results and... (Read Article)

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... (Read Article)