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Gilenya (fingolimod): MS drug under Health Canada review in light of serious adverse events
- Starting date:
- February 27, 2012
- Posting date:
- February 27, 2012
- Type of communication:
- Information Update
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Product Safety, Important Safety Information
- Audience:
- General Public
- Identification number:
- RA-110005370
Health Canada is informing Canadians of an ongoing safety review of the multiple sclerosis (MS) drug Gilenya (the brand name for fingolimod). The review was initiated following reports of serious adverse events, including 11 deaths reported internationally. No deaths have been reported in Canada.
- 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.
Report health or safety concerns
To report suspected adverse reaction (side effect) to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:
- Fax: 1-866-678-6789
- Internet: MedEffect Canada
-
Mail (Get a postage-paid label): Canada Vigilance Postage Paid Label
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9
Media enquiries
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