
Patients Who Stop Taking Gilenya May Experience Worsening of Multiple Sclerosis
The FDA has issued a safety warning that patients who stopped taking Gilenya experienced worsening of multiple sclerosis, compared with before treatment started or during treatment, in rare cases.
Patients with multiple sclerosis (MS) who are taking Gilenya (fingolimod) are being warned to speak with their healthcare providers before stopping their treatment. The
Gilenya is one of several medicines approved to treat relapsing MS and was first approved in the United States in 2010. According to the safety warning, the worsening of MS after stopping treatment with Gilenya is rare but can result in permanent disability.
In the 8 years since the treatment was approved, the FDA identified 35 cases of severe disability, as well as new lesions, that occurred 2 to 24 weeks after treatment with Gilenya stopped. Most cases occurred in the first 12 weeks after stopping therapy.
In
On November 29, after the FDA’s warning, Gilenya was
The FDA is warning patients who experience new or worsened symptoms—such as weakness, increased trouble using arms or legs, or changes in thinking, eyesight, and balance—after treatment with Gilenya is stopped to contact their healthcare professional.
In the 35 cases the FDA identified, the increase in disability was more severe than typical MS relapses. Recovery varied with 17 patients experiencing a partial recovery, 8 experiencing permanent disability or no recovery, and 6 returning to the level of disability they had before or during treatment.
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