Two New Warnings from the FDA on MS Medications

The U.S. Food and Drug Administration (FDA) recently announced warnings for two disease-modifying treatments (DMTs) used in multiple sclerosis (MS): Gilenya® (fingolimod) and Lemtrada® (alemtuzumab).1,2

Severe worsening of MS after stopping treatment with Gilenya

The FDA issued a warning for Gilenya that when the drug is stopped, the disease can become much worse – worse than before the medicine was started. In rare cases, this can result in permanent disability.1

Gilenya is used to treat relapsing MS. People with MS who take Gilenya are advised not to stop the medication without talking to their doctor. If someone has been instructed by a healthcare professional to stop the medication, patients should be alert to any new or worsened symptoms, including weakness, difficulty using arms or legs, or any changes in thinking, eyesight, or balance. Any new or worsened symptoms should be immediately reported to a doctor.1

Risk of stroke and tears in blood vessel walls with Lemtrada

Rare but serious side effects caused a warning from the FDA about Lemtrada. There have been several cases of strokes or tears in the lining of the arteries in the head and neck (called arterial dissection) in people with MS taking Lemtrada. These side effects have occurred shortly after these patients received the medication (within 1-3 days). Stroke and arterial dissection are serious potential side effects and can lead to permanent disability or death.2

Anyone who is receiving Lemtrada for MS who experiences any signs of stroke or tears in the arteries of the head or neck should seek emergency treatment immediately. Common symptoms of stroke or arterial dissection include:2

  • Sudden weakness or numbness in the body (face, arms, or legs), especially if it occurs only on one side of the body
  • Sudden confusion, difficulty speaking, or difficulty understanding speech
  • Sudden vision problems (in one or both eyes)
  • Sudden difficulty with walking, balance, coordination, or dizziness
  • Sudden severe headache or neck pain

Since Lemtrada was approved by the FDA in 2014 to treat relapsing forms of MS, there have been 13 cases reported worldwide of stroke or arterial dissection that occurred shortly after the patient received Lemtrada. As these are the only cases that have been reported to the FDA, the FDA acknowledges that additional cases may have occurred without reporting.2

Reporting side effects to the FDA

Generally, doctors report side effects such as these to the FDA, but consumers can also report issues with side effects to the FDA MedWatch program. The FDA has an online form to complete, which can be faxed to 1-800-FDA-0178 or sent to the address on the form. Additionally, consumers can call 1-800-332-1088 to request a form.

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