Bayer has said that it mistakenly did not inform the FDA about a retrospective study commissioned by the company to analyze the effects of Trasylol in patients undergoing coronary artery bypass graft surgery.
The data should have been shared with the FDA as they are currently conducting a safety review of Trasylol. The review was triggered by the results of two published research studies that reported adverse effects of the drug including kidney problems, heart failure and stroke.
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.
“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,” said Bayer.
The FDA has commented that it was not aware of this research and therefore is actively evaluating these new data and their implications for appropriate use of the drug.
Bayer has submitted a copy of the preliminary report to the FDA and has notified other regulatory authorities.