The U.S. Food & Drug Administration (FDA) has completed its evaluation of a report of an individual who died after initiating a regimen of Novartis’ controversial multiple sclerosis drug Gilenya (generic: fingolimod). The administration has also evaluated a number of reports of Gilenya users who died of cardiovascular events or unknown causes. First approved by the FDA in September 2010, Gilenya is a first-of-its-kind oral medication prescribed for the treatment of relapsing forms of multiple sclerosis in adults.
What’s the problem?
May 14, 2012 – Although the Food & Drug Administration cannot at this juncture prove definitively whether Gilenya caused the deaths of the individuals cited in the reports, the administration nevertheless remains concerned about the cardiovascular effects of the drug after the first dose.
Despite Novartis’ assertion that the maximum heart rate lowering effect of Gilenya peaks within six hours of the initial dose, new data shows that the maximum effect may occur as late as 20 hours after the first dose in some patients. As a result, the FDA is now contraindicating the use of Gilenya in patients with pre-existing heart conditions or stroke, and in those who are simultaneously being treated with certain antiarrhythmic medications. Additionally, the administration is recommending that the period of cardiovascular monitoring be extended past six hours in high-risk patients, and should include continuous overnight ECG monitoring.
Healthcare professionals are advised to take note of Gilenya’s new label changes, and base their decision to prescribe the drug on the FDA’s recommendation for monitoring and the updated contraindications for use in certain patients.
Manufactured and marketed by Novartis Pharmaceuticals, Gilenya is an FDA-approved prescription drug designed to treat relapsing forms of multiple sclerosis. The drug belongs to a class of medications known as sphingosine l-phosphate receptor modulators that work by decreasing the action of immune cells that may cause nerve damage. Multiple sclerosis is a severe disease in which the nerves are unable to function properly, resulting in weakness, numbness, loss of muscle coordination, and problems with speech, vision, and bladder control.