Safety Alerts & Recalls
What does this mean?
It is important not to draw too many conclusions from this single case report involving Gilenya. At this time, the role of Gilenya in the death of this MS patient is unknown. If you take Gilenya and are concerned, please follow up with your doctor who can review with you the benefits and risks of Gilenya in your situation. Please do not stop taking your medicine without first speaking with your doctor.
Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Novartis Issues Safety Information Update Gilenya (fingolimod)
Novartis has been informed of a progressive multifocal leukoencephalopathy (PML) diagnosis in a JCV antibody positive multiple sclerosis (MS) patient who had previously been treated with Tysabri (natalizumab) for approximately three and a half years prior to initiating treatment with Gilenya (fingolimod).
PML is a rare but serious brain infection. The John Cunningham Virus (JCV) is a common virus that many people have been exposed to at some point in their lives, and is generally harmless. However, people with weakened immune systems have an increased chance of developing PML from JCV.
There is a known risk of PML associated with Tysabri treatment, especially in patients who are JCV antibody positive and have been treated with Tysabri for more than two years. The current assessment is that Tysabri is the drug most likely associated with this case of PML. However, it is unknown if Gilenya contributed to the development of this case of PML.
This is the first reported PML case in approximately 36,000 Gilenya-treated patients, of whom approximately 2,400 were treated for more than two years and approximately 500 were treated for more than four years. There is currently no confirmed case of PML reported to Novartis in a Gilenya-treated patient without previous Tysabri treatment.
Novartis is currently gathering all available details on this case report and the details have been submitted to the FDA and other health authorities.
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