On May 15, 2012, FDA announced completion of their safety review of fingolimod (Gilenya, Novartis).
On May 15, 2012, FDA announced completion of their safety review of fingolimod (Gilenya, Novartis), an oral agent approved in September for the treatment of relapsing forms of multiple sclerosis. The safety review was initiated after a report of a patient who died within 24 hours of taking the first dose of fingolimod.
FDA reviewed post-marketing reports of death in patients taking fingolimod and concluded that fingolimod's contribution to each death was unclear and that the number of deaths did not appear to be higher in patients treated with fingolimod compared with patients who were not treated with fingolimod.
FDA also included a re-evaluation of clinical trial data regarding fingolimod's effects on heart rate and blood pressure. The bradycardia effects of fingolimod have been confirmed to be biphasic (within 6 hours and between 12 and 20 hours after the dose). As such FDA suggests monitoring a patient's heart rate beyond the originally recommended 6 hours in patients with a heart rate of 45 bpm or lower within the first 6 hours after the first dose or in patients whose lowest heart rate has been within the first 6 hours. Extended monitoring is also recommended in patients with QT prolongation and in patients who are already taking medication which slows heart rate or atrioventricular (AV) conduction.
FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod). Available at: http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm. Accessed May 16, 2012.
Gilenya [package insert]. FDA. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008lbl.pdf. Accessed May 16, 2012.