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On November 29, 2018, FDA issued a warning that alemtuzumab (Lemtrada) administered in patients with multiple sclerosis (MS) can increase the risk of hemorrhagic and ischemic stroke and tearing of the arterial vessel walls in the head and neck, also known as arterial dissection. These events are rare, but can be life-threatening or permanently disabling. FDA identified 13 cases of hemorrhagic and ischemic stroke or arterial dissection in the US and Europe since alemtuzumab was labeled for treating MS in 2014. Twelve of these cases occurred within 1 day of alemtuzumab administration. One case was fatal. FDA has added a new warning about these risks in the Lemtrada drug label, patient Medication Guide, and the existing Boxed Warning. Alemtuzumab is an intravenous infusion labeled for treating relapsing forms of MS (Lemtrada) and B-cell chronic lymphocytic leukemia (Campath). A causal association between alemtuzumab and stroke in patients being treated for chronic lymphocytic leukemia has not been established. However, the Campath drug label will also be updated to include the risk of stroke and arterial dissection in the Adverse Reactions section.
Seek emergency treatment if you experience signs or symptoms of a stroke (eg, sudden numbness or weakness, confusion, difficulty speaking, vision changes, loss of balance, trouble walking) or if you experience severe headache or neck pain after receiving alemtuzumab. Healthcare providers should remind patients to seek treatment promptly if they experience stroke symptoms. Evaluate complaints of headache or neck pain quickly in patients taking alemtuzumab. Report side effects associated with alemtuzumab or other medications to the FDA MedWatch program.
Additional information can be found in the following links:
FDA Safety Announcement:
- www.fda.gov/Drugs/DrugSafety/ucm624247.htm
FDA Drug Safety Communication:
- www.fda.gov/downloads/Drugs/DrugSafety/UCM626584.pdf