Gilenya(Novartis) patients with Multiple Sclerosis to be monitored after first dosing

The European Medicines Agency has received reports of unexplained deaths of patients taking Gilenya (fingolimod) the Multiple Sclerosis treatment from Novartis.The EMA has advised doctors to monitor patients new to the drug for six hours after first dosing as has the FDA. Six Gilenya patients have died of unknown causes, three of them suddenly. Another four died from cardiovascular problems that may or may not have been caused by the drug. Gilenya can slow patients' heart rates after the first dose. Novartis is co-operating with the regulatory authorities in the USA and EU.