U.K. Regulator Warns Against Gilenya For Heart Patients
U.K. regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), just issued a warning against Gilenya (fingolimod) use in heart patients. The MHRA also called for extended early monitoring for patients diagnosed with significant bradycardia or heart block after the first dose. Gilenya is a sphingosine-1 phosphate … [Read more...] about U.K. Regulator Warns Against Gilenya For Heart Patients
Gilenya to Bear New Label Warnings Following Patient Deaths, Safety Reviews
Novartis has announced that it is modifying the label for Gilenya, its oral multiple sclerosis medication, following safety reviews in the U.S. and Europe. Both the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA) launched Gilenya safety reviews several months ago, after receiving reports of deaths among … [Read more...] about Gilenya to Bear New Label Warnings Following Patient Deaths, Safety Reviews
