FDA to Study Death of Patient After First Fingolimod Dose

December 20, 2011

December 20, 2011 — The US Food and Drug Administration (FDA) will review a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of fingolimod (Gilenya, Novartis Pharmaceuticals), the agency announced today.

The FDA stated that it cannot conclude at this time whether the drug, the first oral treatment for MS, caused the patient's death.

"The FDA believes the benefits of [fingolimod] continue to exceed the potential risks when the drug is used appropriately as described in the approved drug label," the agency stated. It recommends that physicians continue to prescribe fingolimod and that patients not stop taking it without first talking to their physician.

The FDA approved fingolimod in September 2010 to reduce relapses and delay disability progression in patients with MS. Market clearance called for a risk evaluation and mitigation strategy to manage adverse events seen with the drug during clinical trials. These adverse events included bradycardia on first treatment.

Last week, Novartis confirmed that it was investigating the death of a patient on November 23 who had received the first dose of fingolimod the day before. According to the FDA, the patient had also been treated with metoprolol, a beta blocker, and amlodipine, a calcium-channel blocker. The patient had completed 6 hours of monitoring after the first dose without incident.

The agency is advising clinicians to obtain a baseline electrocardiogram before the first dose of fingolimod if one was not recently performed for patients at a higher risk for bradyarrhythmia. They should observe all patients taking the drug for signs and symptoms of bradycardia for 6 hours after the first dose. The FDA noted that fingolimod has not been studied in patients who have ischemic heart disease, congestive heart failure, second-degree or higher conduction block, sick sinus syndrome, or prolonged QT interval.

Patients should be taught to recognize the signs and symptoms of bradycardia, and advised when to seek care, the agency said.

More information about today's announcement is available on the FDA Web site.

To report adverse events related to fingolimod, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online using the MedWatch online voluntary reporting form, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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