Multiple sclerosis (MS) drugs Ocrevus and Gilenya have been linked to melanoma, with Gilenya linked to squamous cell carcinoma and basal cell carcinoma, also. These new drug safety findings come from an analysis of skin cancer cases reported to the FDA Adverse Event Reporting System (FAERS) for patients receiving certain multiple sclerosis (MS) … [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...]