FDA Issues Warning of Rare Brain Infection Linked to Drug for Multiple Sclerosis

The Food and Drug Administration (FDA) announced this week that warnings about a rare brain infection will be added to the label for the multiple sclerosis drug Gilenya (fingolimod).

The FDA said one definite case and one probable case of progressive multifocal leukoencephalopathy (PML) had been reported in patients taking Gilenya for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously taken an immunosuppressant drug for MS or other medical condition. Information about these cases is being added to the drug label warnings.

Gilenya is an immunomodulator, a type of drug that alters the immune system to reduce inflammation. The drug has shown benefits for patients with relapsing forms of MS, a type of MS that causes attacks or relapses, during which symptoms get worse. PML, a rare and serious brain infection, is caused by the John Cunningham (JC) virus. This virus is harmless in most people but can cause PML in people who have immune systems weakened by infections or immunosuppressant drugs.

Patients taking Gilenya should contact their doctor immediately if they experience new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance. The FDA cautions patients not to stop taking Gilenya until they have discussed this with a health care professional. But if PML is suspected, the doctor should have the patient stop Gilenya and should perform a diagnostic evaluation.

Symptoms of PML may include progressive weakness on one side of the body; clumsiness; vision problems; confusion, and changes in thinking, personality, memory and orientation. The progression of deficits can lead to severe disability or death. A magnetic resonance imaging (MRI) scan may find lesions in the brain before any symptoms develop.

In August 2013, the FDA issued a Drug Safety Communication reporting that a patient developed PML after taking Gilenya, but the FDA could not conclusively link PML with Gilenya because that patient had taken an immunosuppressant drug prior to taking Gilenya and during Gilenya treatment had received multiple courses of intravenous corticosteroids, which can weaken the immune system.

Novartis, the manufacturer of Gilenya, notified the FDA about the two PML in patients taking Gilenya treatment without prior or concurrent exposure to other immunosuppressant drugs. The patient with probable PML showed no clinical signs or symptoms of PML; the diagnosis was based on MRI findings compatible with PML and JC virus detected in the cerebrospinal fluid (CSF). The other patient received a definite PML diagnosis based on characteristic symptoms, MRI findings, and JC virus in the CSF. Both patients stopped taking Gilenya.

Information about these two cases has been added to the drug label and to the Medication Guide for Gilenya. Health care professionals and patients are encouraged to report side effects involving Gilenya to the FDA’s MedWatch program; see www.fda.gov/MedWatch/report.

 

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