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The Medicines and Healthcare Products Regulatory Agency (MHRA) has published multiple safety warnings for fingolimod, including new contraindications in relation to cardiac risk and updated advice about the risk of cancers and serious infections.1,2
Fingolimod is licensed as single disease modifying therapy in highly active relapsing remitting multiple sclerosis in adults with highly active disease despite treatment with at least one disease modifying therapy, or adults with rapidly evolving severe disease.3 In its assessment of fingolimod, the European Medicines Agency considered that it exhibited a heterogenous and complex safety profile.4,5 Safety concerns included bradycardia, atrioventricular-block, leucopenia, increased frequency and seriousness of infections, lymphoma related to the …