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fingolimod FDA Alerts

The FDA Alert(s) below may be specifically about fingolimod or relate to a group or class of drugs which include fingolimod.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for fingolimod

Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine

Nov 20, 2018

Audience: Patient, Health Professional, Neurology, Pharmacy

ISSUE: FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.

BACKGROUND: Gilenya is one of several medicines approved to treat a form of MS called relapsing MS, which are periods of time when MS symptoms get worse. The medicine was approved in the United States in 2010.

RECOMMENDATION:

Healthcare professionals should:

  • Inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya.

  • Patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately when Gilenya is stopped.

  • Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped.

  • Test for new or enhancing lesions by magnetic resonance imaging (MRI) if an increase in disability occurs and begin appropriate treatment as needed.

  • Encourage patients to read the patient Medication Guide they receive with their Gilenya prescriptions, which explains the benefits and risks of the medicine.

Patients who have been instructed to stop Gilenya, should contact your health professional immediately if you experience new or worsened symptoms such as:

  • weakness

  • trouble using arms or legs

  • changes in thinking, eyesight or balance.

Patients should not stop taking the medicine on their own and should speak to their health professional first, as stopping treatment can lead to worsening MS symptoms.


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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download 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

[11/20/2018 - Drug Safety Communication - FDA]

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

Aug 29, 2013

Audience: Neurology, Pharmacy

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 Gilenya without first discussing any questions or concerns with their health care professionals. FDA is providing this alert while continuing to investigate the PML case, and is working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. FDA will communicate its final conclusions and recommendations after the evaluation is complete.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download 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

[08/29/2013 - Drug Safety Communication - FDA]

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

May 14, 2012

Audience: Neurology, Patients

[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 6 months) heart conditions or stroke, or who are taking certain antiarrhythmic medications. In addition, FDA is now also recommending that the time of cardiovascular monitoring be extended past 6 hours in patients who are at higher risk for or who may not tolerate bradycardia. Extended monitoring should include continuous ECG monitoring that continues overnight.

Healthcare professionals are encouraged to review the updated drug label for Gilenya, and note specific FDA recommendations for monitoring patients and the new contraindications for use in certain patients.

 

[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 taking Gilenya without talking to their healthcare professional.

FDA will communicate any new information on Gilenya and this case when it becomes available.

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download 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

 

[05/14/2012 - Drug Safety Communication - FDA]
[04/2012 - Gilenya (fingolimod) Prescribing Information]

[12/20/2011 - Drug Safety Communication - FDA]

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

Dec 20, 2011

Audience: Neurology, Patients

[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 taking Gilenya without talking to their healthcare professional.

FDA will communicate any new information on Gilenya and this case when it becomes available.

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download 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

 

[12/20/2011 - Drug Safety Communication - FDA]

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