Aprotinin Injection (marketed as Trasylol) Information

11/5/2007: FDA announces that Bayer, the manufacturer of Traysolol (aprotinin), will suspend the marketing of this drug until a comprehensive review of a Canadian study showing an increased risk of death can be performed. See FDA News. FDA issued a communication in October, 2007, describing recommendation to stop patient enrollment in the aprotinin treatment group arm of the:  Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study. See Early Communication.

• Healthcare Professional Information
• FDA News: FDA Requests Marketing Suspension of Trasylol (11/5/2007)
• Early Communication about an Ongoing Safety Review: Aprotinin Injection (marketed as Trasylol) (10/25/2007)

• November 5, 2007 at 7:30 a.m.
• November 5, 2007 at 11:45 a.m.

Historical Information

• FDA News: FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations (12/15/2006)
  • Healthcare Professional Sheet
• FDA Press Release: FDA Statement Regarding New Trasylol Data (9/29/2006)
  • Patient Information Sheet
  • Healthcare Professional Sheet
  • Public Health Advisory
• FDA News: FDA Issues Public Health Advisory for Trasylol (2/8/2006)
  • Public Health Advisory
  • Questions and Answers
• Regulatory History of Aprotinin from Drugs@FDA 

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