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Canada Announces Gilenya Review

Filed March 2nd, 2012 Laurie

There is an ongoing safety review of the multiple sclerosis (MS) drug Gilenya occurring in Canada in the wake of reports of serious adverse events, including 11 deaths worldwide. None of the deaths occurred in Canada.
Gilenya is a drug prescribed to reduce the frequency of MS attacks and delay physical disability in patients who have relapsing-remitting MS. It is generally prescribed when other MS treatments have been unsuccessful or can’t be tolerated by the patient.

It has not been determined if the deaths were caused by Gilenya or other factors. Four people died after suffering heart-related events including heart attacks and a heart rhythm disturbance. The other seven deaths remain unexplained. One patient in the United States died within 24 hours of taking the first dose.

When Gilenya was authorized, it was known to be associated with certain types of heart rhythm disturbances and that risk was incorporated into the drug’s warning label. However, the benefits of taking the medication are considered to outweigh the risks.

Before taking Gilenya, it is recommended that patients tell their doctor if they are taking other medications, including those that 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.

More information can be found at the Health Canada website.

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