Safety of MS pill Gilenya reviewed after deaths

Health Canada is reviewing a new multiple sclerosis drug that has been linked to 11 deaths.

There have been no reports of deaths in Canada of people taking the Novartis drug, which is sold under the brand name Gilenya.

Gilenya, also called fingolimod, is taken once a day for people with the relapsing-remitting form of MS. (Novartis)

Health Canada says that of the deaths outside the country, it's not clear whether the drug itself caused them, or whether other factors played a role.

Both the U.S. Food and Drug Administration and the European Medicines Agency had earlier announced that they were undertaking reviews of Gilenya.

Gilenya is used for treatment of relapsing-remitting MS to reduce the frequency of attacks and to delay physical disability; it is generally recommended when other MS treatments have not been effective or cannot be tolerated.

At the time the drug was authorized, it was known that certain types of heart rhythm disturbances can be seen with Gilenya use and the Canadian labelling contains several warnings to this effect.

But Health Canada says it felt the drug's benefits outweighed its risks.

Of the 11 reported deaths, four involved serious heart-related events — three were heart attacks and another a disturbance of the heart rhythm. The seven other deaths are unexplained, including one from the United States involving a person who died within 24 hours of his or her first dose of Gilenya.

Health Canada says people taking the drug should not discontinue it without consulting their doctor. But anyone on the drug who is feeling symptoms of heart disease — including chest pain, slow or irregular heartbeat, or dizziness — should seek medical care.

The department says doctors should monitor patients on the drug closely. Blood pressure should be checked regularly as the drug is known to increase blood pressure.

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Safety of MS pill Gilenya reviewed after deaths