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EU Calls for Strengthened and Revised Warnings for MS Drug Gilenya

December 19, 2017 By Law Offices of Thomas J. Lamb, P.A.

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...]

Filed Under: Unsafe Drugs Tagged With: cardiovascular events, drug label warnings, EMA, EU, European Medicines Agency, FDA, fingolimod, food and drug administration, Gilenya, gilenya side effects, immunosuppressive drugs, lymphoma, MHRA, MS drugs, multiple sclerosis drugs, pml, serious infections, skin cancers

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