Bayer suspends employees over Trasylol study
Two Bayer employees have been suspended in connection with the company's failure to disclose trial results about the risks of Trasylol (aprotinin), used to reduce blood loss during heart surgery. The suspended employees are senior members of Bayer's Germany Drug Safety Group.
The FDA began reviewing Trasylol following two published studies that linked the drug with serious side effects including kidney damage, heart attacks, and stroke.
Bayer admitted that it failed to keep the FDA informed of data that could have had a bearing on the outcome of an advisory panel meeting looking at the safety of Trasylol, and whether its use increased the risk of kidney problems, heart attacks and strokes. The FDA panel had concluded that Trasylol was safe and effective but issued a warning on the product after seeing the new data. Bayer stated that it had mistakenly failed to reveal the data because of its preliminary nature.
"Bayer has acknowledged and regrets the error it made in not sharing with the FDA information regarding this study prior to the September 21st Advisory Committee Meeting on Trasylol. Bayer immediately initiated a full investigation into the matter and based on our investigation so far, we believe this was a serious error in judgment by two individuals," commented Dr Roland Hartwig, General Counsel, Bayer.
