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.