FDA WARNS ABOUT CASES OF RARE BRAIN INFECTION

The attention of the Agency has been drawn to the use of Gilenya (fingolimod) which is an immunomodulator shown to benefit patients with relapsing forms of multiple sclerosis (MS). Following recent notification from Norvatis the manufacturer of Gilenya, FDA is warning that a case of progressive multifocal leukoencephalophathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for MS without prior or concurrent exposure to other immunosuppressant drugs.


PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems, including those taking immunosuppressant drugs. Symptoms of PML are diverse and 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. As a result, information about these recent cases is being added to the drug label.

Action required from Prescriber/Patients

Patients taking Gilenya should contact their health care professionals right away if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance.
 Health care professionals should stop Gilenya and perform a diagnostic evaluation if PML is suspected.
Report adverse events or side effects related to the use of these products to NAFDAC PRASCOR system (send text to 20543 from all network providers) or via adverse event report forms or e-mail: pharmacovigilance@nafdac.gov.ng .
Patients should be encouraged to do same.
NAFDAC: Safeguarding the health of the Nation.