Trasylol got something of a reprieve yesterday when an FDA advisory panel recommended that it stay on the market. The committee did suggest changes to the drug's labeling to incorporate info--which drugmaker Bayer previously withheld--from studies that suggested Trasylol raises the risk of death. The advisory panel also asked Bayer to conduct more clinical trials to further gauge its safety.
Trasylol already carries a stern "black box" warning that it be used only in certain patients. Bayer says it will work with the FDA to refine and clarify the labeling. It stopped short of promising new trials, but said it would "move forward with discussions--regarding further clinical activities."
- check out Bayer's release on the decision