FDA warns stopping fingolimod linked to severe MS worsening

 

Patients with multiple sclerosis (MS) who stop taking the MS medication Gilenya (fingolimod) may experience severe disease worsening, according to a safety announcement from the Food and Drug Administration. The disease may become worse than it was before patients started the medication or while patients were taking the drug. Severe worsening is rare but can result in permanent disability, according to the FDA statement.

The FDA identified 35 cases of severely increased disability accompanied by new MRI lesions that occurred 2-24 weeks after Gilenya was stopped. Most patients experienced the worsening symptoms in the first 12 weeks after stopping therapy. The cases were reported either to the FDA or in the medical literature after the 2010 approval of Gilenya in the United States.

“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,” according to the announcement. “Several patients who were able to walk without assistance prior to discontinuing Gilenya progressed to needing wheelchairs or becoming totally bed bound.” Seventeen of the patients partially recovered, eight had permanent disability, and six returned to the level of disability that they had before or during Gilenya treatment.

The patients most often discontinued treatment because they intended to or had become pregnant. Other reasons for halting therapy included lack of efficacy, lymphopenia, infections, or cancer.

The best approach to discontinuing treatment and the best way to treat a severe increase in disability if it occurs has not been determined, according to the FDA statement.

The drug’s safety labeling has been updated to include warnings about the potential for a severe increase in disability after stopping Gilenya. Health care professionals should tell patients about the risk of a severe increase in disability after stopping Gilenya and should monitor patients carefully if they do stop treatment. Patients should seek immediate medical attention after stopping the therapy if they have new or worsened MS symptoms, including trouble using their arms or legs, or changes in thinking, vision, or balance.

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Patients with multiple sclerosis (MS) who stop taking the MS medication Gilenya (fingolimod) may experience severe disease worsening, according to a safety announcement from the Food and Drug Administration. The disease may become worse than it was before patients started the medication or while patients were taking the drug. Severe worsening is rare but can result in permanent disability, according to the FDA statement.

The FDA identified 35 cases of severely increased disability accompanied by new MRI lesions that occurred 2-24 weeks after Gilenya was stopped. Most patients experienced the worsening symptoms in the first 12 weeks after stopping therapy. The cases were reported either to the FDA or in the medical literature after the 2010 approval of Gilenya in the United States.

“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,” according to the announcement. “Several patients who were able to walk without assistance prior to discontinuing Gilenya progressed to needing wheelchairs or becoming totally bed bound.” Seventeen of the patients partially recovered, eight had permanent disability, and six returned to the level of disability that they had before or during Gilenya treatment.

The patients most often discontinued treatment because they intended to or had become pregnant. Other reasons for halting therapy included lack of efficacy, lymphopenia, infections, or cancer.

The best approach to discontinuing treatment and the best way to treat a severe increase in disability if it occurs has not been determined, according to the FDA statement.

The drug’s safety labeling has been updated to include warnings about the potential for a severe increase in disability after stopping Gilenya. Health care professionals should tell patients about the risk of a severe increase in disability after stopping Gilenya and should monitor patients carefully if they do stop treatment. Patients should seek immediate medical attention after stopping the therapy if they have new or worsened MS symptoms, including trouble using their arms or legs, or changes in thinking, vision, or balance.

[email protected]

 

Patients with multiple sclerosis (MS) who stop taking the MS medication Gilenya (fingolimod) may experience severe disease worsening, according to a safety announcement from the Food and Drug Administration. The disease may become worse than it was before patients started the medication or while patients were taking the drug. Severe worsening is rare but can result in permanent disability, according to the FDA statement.

The FDA identified 35 cases of severely increased disability accompanied by new MRI lesions that occurred 2-24 weeks after Gilenya was stopped. Most patients experienced the worsening symptoms in the first 12 weeks after stopping therapy. The cases were reported either to the FDA or in the medical literature after the 2010 approval of Gilenya in the United States.

“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,” according to the announcement. “Several patients who were able to walk without assistance prior to discontinuing Gilenya progressed to needing wheelchairs or becoming totally bed bound.” Seventeen of the patients partially recovered, eight had permanent disability, and six returned to the level of disability that they had before or during Gilenya treatment.

The patients most often discontinued treatment because they intended to or had become pregnant. Other reasons for halting therapy included lack of efficacy, lymphopenia, infections, or cancer.

The best approach to discontinuing treatment and the best way to treat a severe increase in disability if it occurs has not been determined, according to the FDA statement.

The drug’s safety labeling has been updated to include warnings about the potential for a severe increase in disability after stopping Gilenya. Health care professionals should tell patients about the risk of a severe increase in disability after stopping Gilenya and should monitor patients carefully if they do stop treatment. Patients should seek immediate medical attention after stopping the therapy if they have new or worsened MS symptoms, including trouble using their arms or legs, or changes in thinking, vision, or balance.

[email protected]