After finding itself under a barrage of criticism for failing to reveal the safety issues raised in a new study of Trasylol, Bayer has suspended two "senior" employees in Germany who the company says failed to notify the FDA about the new data. The study demonstrated that Trasylol raises the risk of death, heart failure, stroke and kidney damage but was released only a week after an FDA committee met to consider the drug's safety record and possible new warnings. Trasylol is used to limit blood loss during bypass surgery. Fred Fielding of the law firm Wiley Rein & Fielding has also been brought in by the drug maker to examine its handling of the Trasylol data.
- here's the AP report on Bayer's response