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Gilenya News

Kidney Woes Tied to Raised Cancer Risk, Study Finds

Posted 12 Nov 2015 by Drugs.com

THURSDAY, Nov. 12, 2015 – Kidney failure and having a kidney transplant may increase the risk for certain types of cancer, a new study suggests. Poor kidney function and immune system-suppressing drugs may be behind this increased risk, according to Elizabeth Yanik, of the U.S. National Cancer Institute, and colleagues. For the study, published in the Nov. 12 online edition of the Journal of the American Society of Nephrology, the researchers looked at data from more than 200,000 U.S. kidney transplant candidates and recipients. Along with finding that these patients are at increased risk for certain types of cancer, the investigators also identified clear patterns of risk associated with different types of treatment. However, the associations seen in the study do not prove cause-and-effect. The risk of kidney and thyroid cancers was especially high when kidney failure patients were on ... Read more

Related support groups: Cancer, Methotrexate, Renal Failure, CellCept, Gilenya, Tysabri, Imuran, Xolair, Orencia, Chronic Kidney Disease, Revlimid, Arava, Leflunomide, Azathioprine, Afinitor, Tecfidera, Mycophenolate Mofetil, Peritoneal dialysis, Aubagio, Benlysta

FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection

Posted 4 Aug 2015 by Drugs.com

ISSUE: FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking 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 drug label. BACKGROUND: 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 so ... Read more

Related support groups: Multiple Sclerosis, Gilenya, Fingolimod

FDA Medwatch Alert: Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection

Posted 29 Aug 2013 by Drugs.com

ISSUE: FDA is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of progressive multifocal leukoencephalopathy (PML), reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML. BACKGROUND: PML is a rare and serious brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called myelin. PML usually causes death or severe disability. Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. Novartis reports that approximately 71,000 patients worldwide have been treated with Gilenya. RECOMMENDATION: Patients should not stop taking ... Read more

Related support groups: Multiple Sclerosis, Gilenya, Fingolimod

FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose

Posted 15 May 2012 by Drugs.com

[UPDATED 05/14/2012] FDA has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes. FDA could not definitively conclude that Gilenya was related to any of the deaths. However, based on its reevaluation of the data, FDA remains concerned about the cardiovascular effects of Gilenya after the first dose. Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients. For this reason, Gilenya is now contraindicated (FDA advises against its use) in patients with certain pre-existing or recent (within last ... Read more

Related support groups: Multiple Sclerosis, Gilenya, Fingolimod

FDA Issues Multiple Sclerosis Drug Alert

Posted 14 May 2012 by Drugs.com

MONDAY, May 14 – The multiple sclerosis drug Gilenya (fingolimod) should not be given to patients with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to correct heart rhythm problems, says a U.S. Food and Drug Administration safety announcement issued Monday. The warning follows the FDA's evaluation of a report of a patient who died within 24 hours after receiving the first dose of Gilenya. The agency also reviewed additional clinical trial and post-approval data for the drug, including reports of patients who died of cardiovascular or unknown causes. While it couldn't definitively conclude that Gilenya was related to any of the deaths, the FDA said it has concerns about the cardiovascular effects of the drug after the first dose. The data analysis showed that even though the maximum heart rate-lowering effect of the drug usually occurs ... Read more

Related support groups: Multiple Sclerosis, Gilenya, Fingolimod

FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose

Posted 20 Dec 2011 by Drugs.com

[Posted 12/20/2011] ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation. BACKGROUND: Gilenya (fingolimod) is an oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults. Gilenya is used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.  RECOMMENDATION: At this time, FDA continues to believe that Gilenya provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label.  Patients with MS should not stop ... Read more

Related support groups: Gilenya, Fingolimod

Experimental MS Drug Shows Promise

Posted 5 Oct 2011 by Drugs.com

WEDNESDAY, Oct. 5 – A new oral drug for relapsing forms of multiple sclerosis appears to reduce relapse rates and disability progression, according to the results of a so-called phase 3 trial. The experimental drug, teriflunomide, is one of the few oral drugs that treat this type of MS and may, if approved, be a good choice for many MS patients, researchers said. "Basically, these are very good results because not only was the drug effective, but it was also very safe," said lead researcher Dr. Paul O'Connor, director of the Multiple Sclerosis Clinic and MS Research at the University of Toronto in Canada. The report was published in the Oct. 6 issue of the New England Journal of Medicine. A phase 3 trial is done once it is known that a drug is safe and is usually the last step before U.S. Food and Drug Administration approval is sought. For the study, O'Connor's team randomly assigned ... Read more

Related support groups: Multiple Sclerosis, Gilenya, Fingolimod

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