FDA Catches Out Negligent Drug Company ~ OPOLAW Injury Blog

Thursday, January 29, 2009

FDA Catches Out Negligent Drug Company

Bayer Corporation has admitted negligence in failing to share information on the risks of drug Trasylol with the FDA. A contract research organization showed that the use of Trasylol, which slows or prevents bleeding and is frequently used in heart surgery carries an increased risk of kidney damage, strokes, heart failure and death. The FDA received a tip about Trasylol a few days after a September 21 public meeting where Bayer failed to inform them of risks associated with the drug. Bayer admits its failure to disclose date to the FDA was "a mistake on the company's part."

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