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FDA issues PML warning for MS patients taking Gilenya

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Following reports of progressive multifocal leukoencephalopathy among patients taking Gilenya for multiple sclerosis, the FDA has issued a warning of possible infection for those prescribed the immunosuppressant drug.

Gilenya (fingolimod, Novartis) is an immunomodulator used to treat patients with relapsing forms of multiple sclerosis (MS). In 2013, a patient was reported to have developed progressive multifocal leukoencephalopathy (PML) after taking the drug; however, no conclusive link could be made due to previous treatment with multiple courses of IV corticosteroids and another immunosuppressant drug known to cause the infection.

Recently, the FDA was notified by Novartis of two more PML cases, one probable and one confirmed. The patient with probable PML was asymptomatic, but was diagnosed based on MRI results and the detection of JC virus in cerebrospinal fluid. The other patient was diagnosed based on clinical symptoms, MRI and virus detection.

The FDA recommends patients taking fingolimod and are experiencing symptoms to contact a health care professional immediately, and those prescribing the drug to stop treatment if PML is suspected. In addition, information about the two recent cases is being added to the drug label.