Back to RecallTracker
Health Canada Health products

GILENYA (fingolimod) - Risk of Liver Injury

Issued January 18, 2021
Issue
Post-market cases of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have been reported in multiple sclerosis (MS) patients treated with GILENYA. Some of these cases have resulted in acute liver failure requiring liver transplant.
Hazard description
Product safety