Gilenya (Fingolimod) Drug Risk Review: Death Reported with First Dose [update]

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After completion of the evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod) the US FDA could not definitively conclude that Gilenya was related to any of the deaths. Nevertheless the agency remains concerned about the cardiovascular effects of Gilenya after the first dose.

Background of Gilenya (Fingolimod)

Gilenya, also referred to as Fingolimod, is an oral drug used to treat certain degenerative forms of MS (Multiple Sclerosis) found in adults. Oral Fingolimod or Gilenya is used:

• To minimize the frequency of eruptions or medical exacerbations
• To postpone the onset of physical disability.

FDA Alert on Gilenya (Fingolimod)

The FDA reevaluated the report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod) and further clinical trial and postmarket data. Although the agency could not definitively conclude that Gilenya was related to any of the death its concerns on the cardiovascular effects of the drug remain.

There is a contraindication of Gilenya in patients with certain heart conditions or stroke, or under certain antiarrhythmic medications.

Recommendation on Gilenya (Fingolimod)

“For this reason, Gilenya is now contraindicated (FDA advises against its use) in patients with certain pre-existing or recent (within last 6 months) heart conditions or stroke, or who are taking certain antiarrhythmic medications. In addition, FDA is now also recommending that the time of cardiovascular monitoring be extended past 6 hours in patients who are at higher risk for or who may not tolerate bradycardia. Extended monitoring should include continuous ECG monitoring that continues overnight.

Healthcare professionals are encouraged to review the updated drug label for Gilenya, and note specific FDA recommendations for monitoring patients and the new contraindications for use in certain patients.”

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