The Food and Drug Administration (FDA) has issued a warning regarding rare cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection in patients with multiple sclerosis(MS) after receiving Lemtrada (alemtuzumab).
Alemtuzumab, a monoclonal antibody, is also approved for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) under the brand name Campath. The Campath drug label will also be updated to include these risks in the Adverse Reactions section under Postmarketing Experience.
The U.S. Food and Drug Administration (FDA) has issued warning that 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) shortly after they received Lemtrada (alemtuzumab). These problems can lead to permanent disability and even death.
Therefore FDA has added a new warning about these risks to the prescribing information in the drug label and to the patient Medication Guide. FDA has also added the risk of stroke to the existing Boxed Warning, FDA’s most prominent warning.
Since the approval of Lemtrada in 2014, the Agency has identified 13 cases worldwide of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada; 1 patient who suffered a hemorrhagic stroke died. Most cases (12/13) occurred within 1 day of receiving Lemtrada. One patient reported symptoms that occurred 3 days after treatment.
While the etiology is unknown, the adverse events appear to have occurred within the same time frame as cytokine release syndrome, an inflammatory response associated with Lemtrada use. Reports of ischemic stroke and intracerebral hemorrhage have also been documented in patients treated with Campath for B-cell CLL and other leukemias/lymphomas.
Patients or their caregivers should seek emergency treatment as soon as possible if the patient experiences signs or symptoms of a stroke or tears in the lining of the head and neck arteries, called arterial dissection, which can 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
Healthcare professionals should advise patients at each infusion to seek medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. The diagnosis is often complicated because early symptoms such as a headache and neck pain are not specific. Promptly evaluate patients who complain of symptoms consistent with these conditions.