Details
The FDA has completed its evaluation
of a report of a patient who died after the first dose of Gilenya
in December 2011. It also has evaluated additional clinical trial
and postmarket data for Gilenya, including reports of patients
who died of cardiovascular events or unknown causes. While the
review could not definitively conclude that Gilenya was related
to any of the deaths, based on its reevaluation of the data, the
FDA remains concerned about the cardiovascular effects of the
drug after the first dose.
Data shows that although the maximum heart rate lowering effect
of Gilenya usually occurs within six hours of the first dose, the
maximum effect may occur as late as 20 hours after the first dose
in some patients. For this reason, Gilenya is now
contraindicated (FDA advises against its use) in patients with
certain pre-existing or recent (within last six months) heart
conditions or stroke, or who are taking certain antiarrhythmic
medications. The Health
Canada labeling for Gilenya includes several important
warnings related to these risks. Provided Gilenya is used as
recommended in the authorized Health Canada drug label, the
benefits of Gilenya are considered to outweigh the risks at this
time.
People with MS who are taking Gilenya as their disease modifying
therapy are advised to report any symptoms that may suggest that
they may have a heart condition, such as chest pains, weaknesses
or dizziness, with their physicians immediately. Individuals
should not stop taking Gilenya without
talking to their healthcare professional.
For further information or questions related to Gilenya’s safety,
individuals are encouraged to contact the patient support line at
Novartis Pharmaceuticals Canada Inc. at
1-855-745-5467 or their prescribing doctor. Individuals
are encouraged to report suspected side effects to contact Health
Canada’s Canada Vigilance Program at 1-866-234-2345 or through
their website.
The MS Society will continue to monitor the situation and provide
information as it becomes available.
For more information about Gilenya, other treatments, or
information about how to manage your MS, visit mssociety.ca.