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11 Patient Deaths Prompt Canadian Gilenya Review

Feb 28, 2012 | Parker Waichman LLP

Canada has become the latest country to announce a review of the multiple sclerosis drug, Gilenya, following reports of patients who died after taking the medication.  In a notice posted on its website, Health Canada said no Gilenya deaths have been reported among patients using the drug in that country.

Gilenya was approved in Canada in 2011, and is used to treat multiple sclerosis patients who have not responded to, or cannot tolerate other treatments.

So far, 11 deaths have been reported in Gilenya patients, including one who died within 24 hours of taking the drug.  According to Health Canada, four of the 11 reports involved serious heart-related events (three heart attacks and one disturbance of the heart rhythm), while the other seven are unexplained.

The agency pointed out that heart rhythm problems are a possible side effect of Gilenya.  However, Health Canada said the drug’s benefits still outweighs its risk when it is used according to label recommendations. The Gilenya label currently advises physicians to:

  • 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 should consult their doctors if they experience symptoms of heart problems, including hest pain, slow or irregular heartbeat, or feeling dizzy. 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.

In December, the U.S. Food & Drug Administration (FDA) announced it was reviewing Gilenya following the death of patient within 24 hours of taking their first death.  A review was announced by European regulators in January, after Novartis AG confirmed the other 10 deaths among Gilenya patients.

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