Moda Health. Healthcare from your head to your toes. Delta Dental | Moda Health

FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)

[11-20-2018] The Food and Drug Administration (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. As a result, we have added a new warning about this risk to the prescribing information of the Gilenya drug label and patient Medication Guide.

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.

Health care professionals should inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya. When Gilenya is stopped, patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately. Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped.

Patients should contact your health care professional immediately if you experience new or worsened symptoms of MS after Gilenya treatment is stopped. These symptoms vary and include new or worsened weakness, increased trouble using arms or legs, or changes in thinking, eyesight or balance. Gilenya treatment may have to be stopped for reasons such as adverse drug reactions, planned or unplanned pregnancy, or because the medicine is not working. However, patients should not stop taking it without first talking to their prescribers, as stopping treatment can lead to worsening MS symptoms.

In the 8 years since Gilenya was approved in September 2010, we identified 35 cases of severely increased disability accompanied by the presence of multiple new lesions on magnetic resonance imaging (MRI) that occurred 2 to 24 weeks after Gilenya was stopped. Most patients experienced this worsening in the first 12 weeks after stopping. Our analyses include only reports submitted to FDA* and those found in the medical literature, so there may be additional cases about which we are unaware. The severe increase in disability in these patients was more severe than typical MS relapses, and in cases where baseline disability was known, appeared unrelated to the patients’ prior disease state. Several patients who were able to walk without assistance prior to discontinuing Gilenya progressed to needing wheelchairs or becoming totally bedbound. In patients experiencing worsening of disability after stopping Gilenya, recovery varied. Seventeen patients had partial recovery, 8 experienced permanent disability or no recovery, and 6 eventually returned to the level of disability they had before or during Gilenya treatment.

We previously communicated safety information about Gilenya in August 2015 and August 2013 (rare brain infection), May 2012 (revised cardiovascular monitoring recommendations), and December 2011 (safety review of reported death).

To help FDA track safety issues with medicines, we urge health care professionals and patients to report side effects involving Gilenya and other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Moda Health Provider Network

Find a physician, pharmacy or clinic

Opt in for medical

Tell us you're interested and we'll be in touch with details.

Get Started  Get Started

Questions?

If you can't find an answer, please feel free to contact our Customer Service Customer Service Customer Service

Questions?

If you can't find an answer, please feel free to contact our Customer Service

Employer web tools

Benefit Tracker

Check benefits and eligibility

Log in

Account help

Request an account

Provider Reports

For value-based provider programs, including Synergy, Summit, Beacon, Affinity, CPC+, and EOCCO

Log in

Join our email list


Benefit Tracker

Check benefits, eligibility, incentive and utilization

Log In

Account help

Create an account

Producer web tools


Hello.

We have exciting news to share. ODS is changing its name to Moda Health.

Moda comes from the latin term "modus" and means "a way". We picked it because that's what we are here to do: help our communities find a way to better health.

Together, we can be more, be better.

Please select the state you live in, or the state where your employer is headquartered, so we can tailor your experience:

Hello.

Please select the state you live in, or the state where your employer is headquartered, so we can tailor your experience:

Changing your location to Oregon

You can return to your previous location in the site header.