Fingolimod (Gilenya): Warning about rare cases of progressive multifocal leukoencephalopathy (PML)

Last Updated on

August 06, 1015 – The American Food and Drug Administration (FDA) has just issued a warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Fingolimod (Gilenya) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Fingolimod (Gilenya) who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the newest and updated version of the Fingolimod (Gilenya) drug label.

OML IBackground: Fingolimod (Gilenya) is an immunomodulator shown to benefit patients with relapsing forms of MS.  This type of MS causes attacks or relapses, which are periods of time when symptoms get worse.  Immunomodulators alter the immune system to reduce inflammation. 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.

In an August 2013 Drug Safety Communication, FDA reported that a patient developed PML after taking Fingolimod (Gilenya). At the time, PML could not be conclusively linked to Fingolimod (Gilenya) in this case because prior to Fingolimod (Gilenya) treatment the patient had been treated with an immunosuppressant drug that also can cause PML and during Fingolimod (Gilenya) treatment the patient had received multiple courses of intravenous corticosteroids, which can weaken the immune system.

Recommendation: Patients taking Fingolimod (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. Patients should not stop taking Fingolimod (Gilenya) without first discussing it with their health care professionals. Health care professionals should stop Fingolimod (Gilenya) and perform a diagnostic evaluation if PML is suspected. See the Drug Safety Communication for additional recommendations.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at

Additional topic information: Since immunodeficiency causes this virus to progress to PML, immunosuppressants are contraindicative to those infected. We should note that in  fact, a number of marketed drugs have been associated with PML with  according action by the FDA as follows: The boxed warning for the drug Rituximab  (Rituxan) includes a statement that JC virus infection resulting in PML and death has been reported in patients treated with the drug. The boxed warning for the drug Natalizumab (Tysabri)  includes a statement that JC virus resulted in progressive multifocal leukoencephalopathy developing in three patients who received natalizumab in clinical trials. The boxed warning was added on Feb. 19, 2009, for the drug Efalizumab (Raptiva) includes a statement that JC virus, resulting in progressive multifocal leukoencephalopathy, developed in three patients who received efalizumab in clinical trials. The drug was pulled off the market because of the association with PML on April 10, 2009. A boxed warning for Brentuximab vedotin (Adcetris) was issued by the FDA on January 13, 2011 after two cases of PML were reported. Lately, risks for the development of PML in some patients taking Dimethyl Fumarate (Tecfidera) and Belatacept (Nulojix) have been discussed as well.

Print Friendly, PDF & Email

Tags: , , , , , , , ,
About the Author
Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Your opinion


No comments yet

thasso: conditions

thasso: tweets

thasso post: magazine

View my Flipboard Magazine.

thasso: categories

thasso: archives

thasso: simple chat

You must be a registered user to participate in this chat.

  • Citizen science and paddle surf to study microplastic pollution in Barcelona's coastline February 27, 2020
    A team of the University of Barcelona has studied for the first time the presence of microplastics in the coasts of Barcelona, with the collaboration of the citizens gathering scientific samples. The study, published in the journal Science of Total Environment, is a pioneer citizen science study worldwide, since it analyses a hard-access area for […]
  • Celiac disease might be cured by restoring immune tolerance to gliadin February 27, 2020
    Celiac disease affects 0.3-2.4% of people in most countries world-wide, and approx. 2% in Finland. Celiac patients suffer from a variety of symptoms, typically intestinal complaints, such as diarrhea, but are often symptom-free. Immunologist Tobias Freitag co-developed and tested nanoparticles containing gliadin for the immunomodulatory treatment of celiac disease in Professor Seppo Meri's research group […]
  • Abnormal growth of bacterial cells could be linked to anti-microbial resistance February 27, 2020
    Scientists from the University of Surrey have identified mutations in a gene in an Escherichia coli (E.coli) model that could help explain a form of anti-microbial resistance (AMR) known as 'persistence'.
  • Study unravels how our immune system deals with fungal and viral infections February 27, 2020
    The body's immune response to fungal infections changes when a patient is also infected by a virus, according to new research which investigated the two types of infection together for the first time.
  • How the brain separates words from song February 27, 2020
    The perception of speech and music -- two of the most uniquely human uses of sound -- is enabled by specialized neural systems in different brain hemispheres adapted to respond differently to specific features in the acoustic structure of the song, a new study reports.