"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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The maximum amount of Trasylol® (aprotinin) that can be safely administered in single or multiple doses has not been determined. Doses up to 17.5 million KIU have been administered within a 24 hour period without any apparent toxicity. There is one poorly documented case, however, of a patient who received a large, but not well determined, amount of Trasylol® (aprotinin) (in excess of 15 million KIU) in 24 hours. The patient, who had pre-existing liver dysfunction, developed hepatic and renal failure postoperatively and died. Autopsy showed hepatic necrosis and extensive renal tubular and glomerular necrosis. The relationship of these findings to Trasylol® (aprotinin) therapy is unclear.
Hypersensitivity to aprotinin.
Administration of Trasylol® (aprotinin) to patients with a known or suspected previous aprotinin exposure during the last 12 months is contraindicated. For patients with known or suspected history of exposure to aprotinin greater than 12 months previously, see WARNINGS. Aprotinin may also be a component of some fibrin sealant products and the use of these products should be included in the patient history.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/20/2017
Additional Trasylol Information
- Trasylol Drug Interactions Center: aprotinin (bovine) iv
- Trasylol Side Effects Center
- Trasylol FDA Approved Prescribing Information including Dosage
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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