The risk of mortality with the new ORAL multiple sclerosis drug fingolimod (Gilenya) is too high to use it safely.

This is false...but safety precautions are necessary when starting therapy. Gilenya (fingolimod) is the first ORAL drug for reducing relapses in patients with relapsing-remitting multiple sclerosis.

While 15 deaths have been reported in multiple sclerosis patients starting fingolimod, it’s not clear if they were caused by the drug. But you’ll see new restrictions and warnings designed to improve fingolimod’s safety.

Cardiovascular effects are the primary concern. Fingolimod lowers heart rate within 6 hours after a dose...and again 12 to 20 hours post-dose. New patients can develop serious bradycardia or heart block. Some patients don’t tolerate a drop in heart rate and shouldn’t get the drug...and for others the only way to safely find out if they tolerate the drug is first-dose monitoring.