Health Canada

Health Canada

February 27, 2012 08:12 ET

Gilenya (Fingolimod): MS Drug Under Health Canada Review in Light of Serious Adverse Events

OTTAWA, ONTARIO--(Marketwire - Feb. 27, 2012) - 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.

Gilenya is a prescription drug authorized for the treatment of relapsing-remitting multiple sclerosis to reduce the frequency of attacks (relapses) and delay physical disability. Gilenya is generally recommended when other MS treatments have not been effective or cannot be tolerated. It was authorized in Canada in March 2011.

Currently, it is not clear whether the deaths were caused by Gilenya or whether other factors may have played a role. Four of the 11 reports involved serious heart-related events (three involved heart attacks and one involved a disturbance of the heart rhythm), while the other seven are unexplained. Among these seven is a report involving a patient in the United States who died within 24 hours of taking the first dose.

At the time of authorization, it was known that Gilenya can be associated with certain types of heart rhythm disturbances. The Canadian labelling contains several important warnings with respect to these risks. At this time, when the drug is used as recommended in the authorized Canadian drug label, the benefits of Gilenya are considered to outweigh the risks.

Healthcare professionals are advised 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.

Patients taking Gilenya who experience symptoms of heart problems should report them immediately. Symptoms include chest pain, slow or irregular heartbeat, or feeling dizzy. Patients should not stop taking Gilenya without first consulting a healthcare professional. Patients who have any questions or concerns about their Gilenya therapy should speak to their healthcare professional.

Before starting Gilenya, patients should tell 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.

Health Canada continues to assess all available information, including information from the company (Novartis), and information from other regulators. Health Canada will take appropriate action based on the results of its review. This includes communicating new safety information to health professionals and the public as soon as the review is complete, as appropriate.

Drug labels, also known as "Product Monographs," contain important prescribing and safety information for health professionals and patients, and are available by search of Health Canada's Drug Product Database (http://webprod3.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp).

How to report side effects to health products

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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) and send to us using one of these methods:

- Fax: 1-866-678-6789

- Internet: www.healthcanada.gc.ca/medeffect

- Mail (Get a postage-paid label (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php)):

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

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