US Food and Drug Administration revises recommendations for cardiovascular monitoring and use of Gilenya (fingolimod)
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.