FDA Warns of Rare Risks of MS Drug Alemtuzumab

The FDA has issued a warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) who received treatment with alemtuzumab (Lemtrada).

According to the agency, these adverse events can lead to permanent disability and even death. Most patients taking the treatment who developed either problem had symptoms within 1 day of receiving the treatment. One patient reported symptoms 3 days after treatment.

The FDA recommends that patients or their caregivers seek emergency treatment as soon as possible if the patient experiences signs or symptoms of a stroke or tears in the lining of head and neck arteries, which include:

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

They also recommend that during every alemtuzumab infusion, healthcare professionals should advise patients to seek immediate emergency medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. According to the agency, the diagnosis is often complicated because early symptoms, such as head and neck pain, are nonspecific.

Alemtuzumab gained FDA approval for relapsing forms of MS in 2014. Since its approval, the FDA has identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after treatment. The FDA noted that additional cases they were not made aware of may have occurred.

The FDA added a new warning about these risks to the prescribing information drug label and to the patient Medication Guide.

Alemtuzumab is also approved under the brand name Campath, which was approved in May 2001 for B-cell chronic lymphocytic leukemia. The drug label for this indication will also be updated to include these risks.

Last month, the FDA issued a warning regarding the MS treatment fingolimod (Gilenya). They warned patients to speak with their healthcare providers before stopping the treatment due to rare cases of MS becoming worse compared with before treatment started or during treatment.