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 … [Read more...]
Warning About Gilenya Birth Defects From Health Canada In December 2019
This December 2019 Health Canada warning about Gilenya birth defects, ” “GILENYA (fingolimod) – Risk of Congenital Malformations”, starts with these two points: When used during pregnancy, GILENYA (fingolimod) has been associated with an increased risk of major congenital malformations, including congenital heart disease such as atrial septal … [Read more...]
EU Calls for Strengthened and Revised Warnings for MS Drug Gilenya
UPDATE: On December 15, 2017, the FDA released an updated drug label for Gilenya with increased warnings. (12/27/17). Background After conducting a routine review of the immunosuppressive drug Gilenya (fingolimod), the Medicines and Healthcare Products Regulatory Agency (MHRA) recently suggested that the drug label for Gilenya be … [Read more...]