Bayer Corporation failed to share data on the risks of Trasylol with the FDA. Trasylol is a drug that slows or prevents bleeding and is often used in heart surgery. The data came from a retrospective study, done for Bayer by a contract research organization, suggesting an increased risk of death, kidney damage, heart failure and strokes with the use of Trasylol. Bayer did not provide the information to the FDA at a September 21 public meeting, and a few days later the FDA received a tip about the data. Bayer said that its action was “a mistake on the company’s part.”
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