Back to Trasylol®

Bayer Inc., in consultation with Health Canada, has informed health care professionals of new safety information regarding the drug Trasylol® (aprotinin). Trasylol® is a medication injected during coronary artery bypass graft surgery and other heart surgeries to help reduce bleeding and the need for blood transfusions.

The new Trasylol® safety information includes:

• Trasylol® may cause life-threatening allergic reactions. Healthcare professionals have been advised that they should have the necessary medications and equipment on hand to deal with these reactions.
• Trasylol® should only be used in heart bypass surgery when the patient is at high risk of bleeding and the need of a blood transfusion.
• Trasylol® must not be used in any patient who has previously taken Trasylol® (aprotinin) within the last 12 months because of the increased risk of an allergic reaction.
• Trasylol® use may lead to kidney damage or failure and there may be a need for dialysis after surgery. Patients who already have kidney problems are at higher risk of developing kidney problems when given Trasylol®.

Health care professionals have also been advised that they must carefully assess the risks and benefits of using Trasylol® in patients who have had any prior exposure to the drug or any other aprotinin-containing drug.

This Trasylol® advisory is in addition to a letter issued to health care professionals concerning this information. The letter can be accessed at Bayer's website.

The Canadian prescribing information for Trasylol® has been updated to include new information in the Contraindications, Warnings and Precautions, and Adverse Reaction sections. In addition, Consumer Information for Trasylol® in the Canadian prescribing information has been updated with new safety information.

Bayer continues to actively review information pertaining to the use of Trasylol® and has requested that health care professionals closely monitor patients following Trasylol® administration and report any serious adverse events to Bayer.

If you or someone you know has undergone a coronary artery bypass grafting surgery and subsequently developed the onset of kidney failure, please use the form on the left to contact our law firm.

Reference:

"Bayer HealthCare - Public Communication - Health Canada Endorsed Important Safety Information on TRASYLOL®," www.cnw.ca, March 2007.