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September 21, 2006—Bayer representatives withheld critical information
from FDA health officials during a meeting to address health concerns over Trasylol.
The FDA
has been reassessing the safety of Trasylol since February 2006, in response to two separate
studies that found the drug was linked to kidney problems and other serious side effects.
A subsequent study conducted by Bayer, and concluded prior to the September 21st meeting,
substantiated these findings and found Trasylol can increase the risk of death, kidney damage,
heart failure and stroke. This data was not disclosed at the FDA meeting.
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