Filing a Gilenya lawsuit is an option for patients who experienced severe worsening of MS symptoms after they stopped treatment with the immunosuppressant medication.
The nationwide law firm of Bernstein Liebhard LLP is offering free legal reviews to individuals interested in filing a Gilenya lawsuit for worsening MS symptoms.
If you or someone you love stopped taking Gilenya and experienced a severe MS fare-up or became permanently disabled, please call (888) 994-5118 to speak with a member of our legal team today.
Novartis developed Gilenya (fingolimod) to reduce the frequency of flare-ups associated with relapsing multiple sclerosis, or MS. At this time, the medication is indicated for use in adults and children over the age of 10.
Gilenya prevents lymphocytes from traveling from the lymph nodes to the central nervous system. As a result, the nerve damage associated with MS is prevented or reduced.
Gilenya was the first oral medication that actually altered the course of MS. Prior to its approval in 2010, injectable drugs were the only option for patients suffering from the disabling autoimmune disease.
For that reason, the U.S. Food & Drug Administration (FDA) did not require rigorous safety studies when it initially approved Gilenya for adults in 2010. However, adverse events reported during clinical trials indicated a possible risk of toxicity, infection, reduced pulmonary function, birth defects, and macular edema.
In December 2017, the FDA granted Gilenya breakthough therapy status for the treatment of children and adolescents ages 10 years or older with relapsing MS. This designation allowed the agency to expedite its review. The FDA approved the expanded indication in May 2018.
Gilenya has undoubtedly helped thousands of MS patients. However, the drug may cause some very serious side effects, including a rare brain infection called progressive multifocal leukoencephalopathy (PML) and certain heart problems.
On November 20, 2018, the FDA warned that MS symptoms may become significantly worse once Gilenya is stopped. Although rare, the worsening of symptoms can lead to permanent disability.
“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,” the alert noted. “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.”
Most of the patients stopped taking Gilenya because they were pregnant or wanted to conceive. In some cases, the drug was ineffective. Others stopped using Gilenya because of cancer or other health issues.
Apparently, the 35 patients experienced relapses that were far more severe than a typical MS flare-up.
What’s more, a minority of patients recovered from their flare-up.
Unfortunately, several people who could walk before their treatment ended either now require wheelchairs or have since become bedridden.
So far, however, the FDA has not determined the best approach to discontinuing Gilenya or the best way to treat a severe increase in disability if it occurs.
Most importantly, the FDA advised patients not to stop taking Gilenya without first speaking with their doctor.
However, patients who have stopped (for example, for an adverse drug reaction or unplanned pregnancy) should seek medical attention if they experience:
Patients who suffer Gilenya side effects, including a worsening of symptoms once treatment stops, can report their experience to the FDA online. Additionally, call 1-800-332-1088 to request a reporting form.
Patients who stopped taking Gilenya and experienced worsening MS symptoms or severe disability may be entitled to compensation for:
To learn if you qualify for a Gilenya lawsuit, please contact Bernstein Liebhard LLP by completing the form on this page, or call our office directly at (888) 994-5118.
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