Multiple sclerosis patients prescribed Gilenya (fingolimod) are now being informed about a handful of documented cases where the therapy was found to have led to a rare brain infection, according to the US Food and Drug Administration. The FDA has released a public warning indicating that cases of progressive multifocal leukoencephalopathy (PML) have been reported in several patients taking the drug. Even though these PML cases are the first to be reported and linked to the drug in patients who have no history of receiving any type of immunosuppressive therapy, the FDA is now mandating Gilenya’s manufacturer, Novartis Pharmaceuticals, add the appropriate warning to the drug’s label.
Gilenya, an immunomodulator that has shown significant therapeutic benefits in patients with relapsing MS, first received FDA approval in September 2010. The FDA is on alert that this potent immunosuppressant may predispose those taking it to a rare and highly fatal brain infection called PML, which is caused by the John Cunningham (JC) virus. While this virus is relatively common and oftentimes harmless, patients with compromised immune systems are not equipped to fend off an infection.
This is not the first time the FDA was alerted to a case of PML in a patient taking Gilenya, however. In August 2013, a PML case was reported but could not be conclusively linked to the drug, as the patient had previously received immunosuppressants before taking Gilenya, and had been exposed to several courses of IV corticosteroids.
Patients currently taking Gilenya should be aware of the following potential symptoms of PML: new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance. Patients are advised to immediately contact their healthcare provider, but should not stop taking Gilenya without proper consultation with a professional. Healthcare providers should immediately withhold Gilenya upon suspection of PML.
Both healthcare professionals and patients are urged to report any notable instances of Gilenya-associated PML to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.
Download this form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.