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Gilenya (fingolimod) under Health Canada review

Summary
Health Canada has announced an ongoing safety review of Gilenya (fingolimod) following the reports of serious adverse events, including 11 deaths internationally. At this time, it is not clear whether the deaths were caused by Gilenya or whether other factors may have played a role. There have been no deaths in Canada.

Details
Health Canada’s review was initiated following reports earlier this year that 11 deaths have occurred among people being treated with Gilenya, including the report of an American who died within 24 hours of receiving a first dose of Gilenya in December 2011.

At the time of approval in March 2011, it was known that Gilenya could be associated with certain types of heart rhythm disturbances. The Health Canada labeling for Gilenya includes several important warnings related to these risks however, provided Gilenya is used as recommended in the authorized Health Canada drug label, the benefits of Gilenya are considered to outweigh the risks at this time.

Health Canada is advising healthcare professionals to continue to follow the labeling instructions closely, particularly with respect to patient monitoring. Specifically, the label recommends that physicians:

  • Obtain an ECG (electrocardiogram) before the first dose if one is not available in the last 6 months
  • Observe patients for signs and symptoms of bradyarrhythmia (slow heart rate), including periodic assessment of heart rate, for at least six hours after the first dose (or if more than two weeks have passed since the previous dose).
  • Initiate appropriate treatment if clinically important heart-related symptoms occur. Symptoms include bradyarrhythmia or atrioventricular block (a problem with the conduction of electricity in the heart). Continue to manage and monitor patients until symptoms have resolved.
  • Measure blood pressure regularly as Gilenya is known to increase blood pressure.

Individuals taking Gilenya who experience symptoms of heart problems should report them immediately to their doctor. Symptoms include chest pain, slow or irregular heartbeat, or feeling dizzy. Individuals should not stop taking Gilenya without talking to their healthcare professional. For further information or questions related to Gilenya’s safety, individuals are encouraged to contact the patient support line at Novartis Pharmaceuticals Canada Inc. at 1-855-745-5467 or their prescribing doctor.

Before starting treatment with Gilenya, individuals should inform their doctor if they are taking other medications such as drugs used to treat abnormal heart rhythms, beta blockers or calcium channel blockers, or if they have a history of heart-related problems such as low heart rate, heart rhythm disorders, congestive heart failure, or fainting.

To report suspected adverse reaction (side effect) to Gilenya, individuals are advised to contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and return the form using one of the following options:

Fax: 1-866-678-6789
Internet: www.healthcanada.gc.ca/medeffect
Mail: (Get a postage-paid label)

Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9

The MS Society of Canada will continue to monitor the situation and provide information as it becomes available.


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