The atmosphere could be contentious when Bayer's Trasylol comes before an FDA advisory committee Wednesday. FDA documents posted in advance of the meeting state that the agency's statisticians concluded that the drug--used to control bleeding during heart surgery--may increase risk of kidney failure and death (a.k.a. "mortality disadvantage").
That the committee is discussing Trasylol again is in itself a story. The company withheld data about possible risks of the drug from the FDA last year; two employees have been suspended because of it.
- read the FDA's briefing report
Investigator: Bayer did not hide Trasylol data. Report
Bayer kept Trasylol safety study hidden from FDA. Report