As reported in this European Medicines Agency (EMA) periodic safety update report, “Gilenya (fingolimod): Updated recommendations to minimise the risk of drug-induced liver injury (DILI)”, published November 10, 2020, there have been cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya.
A Direct Healthcare Professional Communication document which was part of the November 2020 EMA periodic safety update provides these details about the cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya:
Following the most recent periodic review of safety data, three cases of liver failure requiring liver transplant have been reported in patients treated with [Gilenya (fingolimod)], including one case implying a strong causal relationship with [Gilenya (fingolimod)]. Cases of clinically significant liver injury have also been reported. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have occurred as early as ten days after the first dose and have also been reported after prolonged use.
We will continue to monitor the Gilenya safety profile with special attention to cases of Gilenya-related liver failure and drug-induced liver injury associated with Gilenya.
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