Gilenya Deaths Lead to Canadian Safety Review

Canadian health officials have joined a growing number of countries who are investigating the side effects of Gilenya, a multiple sclerosis drug that is suspected of causing a number of heart-related deaths. 

Health Canada announced the Gilenya safety review on February 27, noting that there have been at least 11 deaths reported internationally, but none so far in Canada. The agency is calling on Canadians taking the drug to report any symptoms of heart problems to their doctor immediately.

While the deaths have not been conclusively linked to Gilenya, suspicions that the drug is causing the problem has led to similar investigations in the U.S. and Europe.

Of the 11 deaths, three were caused by heart attacks and one was caused by a disruption of heart rhythm. The remaining deaths are unexplained. Several occurred less than 24 hours after taking the first dose of Gilenya, as do many non-fatal adverse event reports.

Gilenya (fingolimod) is a Novartis drug approved in 2010 as an oral treatment for relapsing forms of MS in adults. It is used to reduce how often flare-ups occur and to delay the onset of physical disability caused by MS.

The risk of some heart irregularities after the first dose were a concern before the drug was approved. Known side effects of Gilenya include a decrease in heart rate and/or atrioventricular conduction after the first dose. It is also known to increase the risks of developing heart blocks or bradycardia when taken with some other drugs, including beta blockers and calcium channel blockers.

In the United States, the FDA is recommending that patients be informed Gilenya may cause serious side effects, such as a low heart rate, that can cause symptoms including dizziness, fatigue and palpitations after the first dose. The heart rate typically returns to normal within the first month of taking the drug. Patients should contact their health care provider if these symptoms occur.