Gilenya Patient Death Sparks FDA Safety Review

The death of a patient after just one dose of Gilenya has federal regulators concerned about the safety of the multiple sclerosis (MS) drug. 

The FDA issued a Gilenya drug safety communication on December 20, announcing that it was investigating the death of a patient with multiple sclerosis linked to the relatively new treatment.

The patient died less than 24 hours after receiving the dose of Gilenya and the exact cause of death is unknown at this time.

Gilenya (fingolimod) is a Novartis drug approved in 2010 as an oral treatment for relapsing forms of MS in adults. It is used to reduce how often flare-ups occur and to delay the onset of physical disability caused by MS.

Known side effects of Gilenya include a decrease in heart rate and/or atrioventricular conduction after the first dose. It is also known to increase the risks of developing heart blocks or bradycardia when taken with some other drugs, including beta blockers and calcium channel blockers. The deceased patient was taking both, the FDA reports.

The FDA announced it is evaluating the safety of the drug in light of the recent death and will communicate any new information that it finds. Currently, the agency cannot say that Gilenya caused the patient’s death and believes that data indicates that the risk of Gilenya side effects are outweighed by the drug’s benefits.

The FDA is recommending that patients be informed Gilenya may cause serious side effects, such as a low heart rate, that can cause symptoms including dizziness, fatigue and palpitations after the first dose. The heart rate typically returns to normal within the first month of taking the drug. Patients should contact their health care provider if these symptoms occur.

Doctors are being advised to carefully follow the drug’s label recommendations, observe all Gilenya patients for signs of bradycardia for six hours after the first dose and obtain a baseline ECF before the first dose.