MS Drug Linked to Definite PML: New Warning Added

The Food and Drug Administration (FDA) confirmed that a case of definite progressive multifocal leukoencephalopathy (PML) and probable PML have been reported in patients taking Gilenya (fingolimod; Novartis) for multiple sclerosis (MS).

These are the first PML cases in patients taking Gilenya without prior or concurrent exposure to other immunosuppressants. The patient with definite PML was diagnosed based on characteristic symptoms, MRI findings, and JC virus in the cerebrospinal fluid. The patient with probable PML was diagnosed based on MRI findings compatible with PMl and JC virus detected in the CSF though the patient did not have clinical signs or sypmtoms suggestive of PML. Data regarding these recent cases are being added to the "Warnings and Precautions" and "Patient Counseling Information" sections of the drug label.

In August 2013, the FDA reported that a patient developed PML after taking Gilenya but could not definitively link it to its use because the patient had taken an immunosuppressant prior to Gilenya treatment, and had taken multiple courses of IV corticosteroids during Gilenya treatment. The immunosuppressant had potential to cause PML and the corticosteroids could also weaken the immune system.

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The FDA recommends that patients should contact their healthcare provider if symptoms such as new or worsening weakness, increased difficulty using their arms or legs, or changes in thinking, eyesight, strength, or balance develop. Healthcare providers should stop Gilenya and perform a diagnostic evaluation if PML is suspected.

Gilenya is a sphingosine 1-phosphate receptor modulator indicated to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in relapsing forms of MS.

For more information call (888) 463-6332 or visit FDA.gov.

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