Back to Trasylol®

New Boxed Warning

Trasylol® (aprotinin) may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial dose as well as a dose regimen. Fatal reactions have also occurred in situations where the initial Trasylol® dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior Trasylol® exposure and a history of any prior Trasylol® exposure must be sought prior to administration. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior Trasylol® exposure....

Contraindications

Administration of aprotinin to patients with a known or suspected previous aprotinin exposure during the last 12 months is contraindicated. Trasylol® may also be a component of some fibrin sealant products and the use of these products should be included in the patient history.

Warnings

• Re-exposure to Aprotinin
• Anaphylactic or Anaphylactoid Reactions
• Renal Dysfunction

Precautions

General

• Initial (Test) Dose
• Renal Dysfunction

Adverse Reactions

• Myocardial Infarction - Incidence of Myocardial Infarctions by Treatment Group Population
• Laboratory Findings - Serum Creatinine and Serum Transaminases

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:

"MedWatch - December 2006 Safety-Related Drug Labeling Changes," FDA, December 2006.