Health Canada Launches Gilenya Review Following Patient Deaths

Health Canada is reviewing the multiple sclerosis drug, Gilenya (gingolimod), following reports of 11 deaths among users of the medication. According to a notice posted on the agency’s website, it is not clear whether the deaths were caused by Gilenya or whether other factors may have played a role.

As we reported previously, Gilenya was already being reviewed by regulators in the U.S. and Europe. The U.S. review was announced last December, after one patient died within 24 hours of taking their first dose of Gilenya. European regulators started their review last month, after receiving reports of 10 additional deaths among Gilenya patients. According to the drug’s maker, Novartis AG, six of those deaths were unexplained, three resulted from heart attacks and one was due to disruption of heart rhythm.

One of the known side effects of Gilenya is brachycardia, or a slow heart rate. However, according to the U.S. Food & Drug Administration (FDA), heart rate usually returns to normal within 1 month after patients start taking the drug. European regulators have advised doctors to increase patient monitoring after the first dose of Gilenya is given, including electrocardiograms before treatment and for the first six hours after the first dose, and then checking blood pressure and heart rate every hour. Patients with a slow heart rate or problems with electricity conduction in the heart should be watched until their condition has improved, they said.

According to the Health Canada notice, Gilenya patients should consult their doctors if they experience symptoms of heart problems, including chest pain, slow or irregular heartbeat, or feeling dizzy. Patients should not stop taking Gilenya without first consulting a 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

The agency said it 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.

Gilenya was approved for the treatment of relapsing-remitting multiple sclerosis in 2010. It was the first multiple sclerosis drug approved in pill form, and is used to reduce the frequency of multiple sclerosis flare-ups and delay physical disability. Since its approval, more than 30,000 people worldwide have taken Gilenya, according to the FDA.

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