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Home » FDA TO CONTINUE EVALUATION OF TRASYLOL SAFETY
FDA TO CONTINUE EVALUATION OF TRASYLOL SAFETY
October 2, 2006
The FDA said it has been conducting a safety review of Bayer's Trasylol(aprotinin injection), which is used to reduce blood loss during some types of heart surgeries, since January. The review was triggered by the results of two published studies: one that reported an increase in the chance of kidney failure, heart attack and stroke in patients treated with Trasylol compared with those treated with other similar drugs, and the other that reported an increase in kidney dysfunction compared with another drug.
The FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee on Sept. 21 to discuss the safety and overall risk-benefit profile for Trasylol. The committee voted 18-0, with one abstention, to recommend Trasylol as safe and effective for patients undergoing coronary artery bypass graft surgery.
On Sept. 27 Bayer told the FDA that it had conducted an additional safety study of Trasylol, according to the agency. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. The FDA said it was not aware of these new data when it held the advisory committee meeting.
Bayer has issued a release saying that it mistakenly did not inform the FDA about the study. 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, the company said.
KEYWORDS Drug Pipeline Alert
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