FDA Issues Warning About Rare Risk of Stroke and Artery Wall Tears with Use of Lemtrada
December 4, 2018
- The FDA has issued a warning about rare but serious cases of stroke and tears to the wall of arteries in the head and neck (ischemic and hemorrhagic stroke and cervicocephalic arterial dissection) that have occurred shortly after individuals received an infusion of Lemtrada® (alemtuzumab, Sanofi Genzyme). The agency noted that these problems can lead to serious disability and even death.
- The warning was based on 13 cases reported to the FDA since Lemtrada was approved in 2014.
- The agency has added this risk to the Boxed Warning and added other updates to the prescribing information and patient Medication Guide.
- The warning outlines possible symptoms of stroke and tears to the walls of arteries that patients and caregivers should be alert to (detailed below).
- Prescribers are advised to inform patients at every Lemtrada infusion to seek immediate emergency medical attention if they experience any of the symptoms detailed below.
The U.S. Food and Drug Administration (FDA) has issued a warning
that rare but serious cases of stroke and tears in the lining of arteries in the head and neck (ischemic and hemorrhagic stroke and cervicocephalic arterial dissection) have occurred in individuals with MS shortly after they received Lemtrada (alemtuzumab). The agency warned that these problems can lead to serious disability and even death.
The warning was based on 13 cases reported to the FDA since Lemtrada was approved in 2014. Most of those taking Lemtrada who developed stroke or tears in the artery linings developed symptoms within one day of receiving Lemtrada. One person reported symptoms that occurred three days after treatment.
The FDA has added a new warning about these risks to Lemtrada’s prescribing information in the drug label, including a prominent Boxed Warning, and to the patient Medication Guide. (The agency has also updated the drug label of Campath, the brand name of alemtuzumab used in the treatment of a form of cancer.
Symptoms to Watch For:
The FDA warning notes that patients or their caregivers should seek emergency treatment as soon as possible if symptoms of these problems occur, which can include:
Advice to Healthcare Providers:
- 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
The FDA recommends that healthcare providers advise patients at every Lemtrada infusion to seek immediate emergency medical attention if they experience symptoms indicative of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. The agency warns that the diagnosis is often complicated because early symptoms such as headache and neck pain are not specific. The FDA recommends promptly evaluating patients who complain of symptoms consistent with these identified conditions.
Healthcare providers are urged to report serious adverse events to the FDA MedWatch program. (Complete and submit the report Online
or Download form
or call 1-800-332-1088 to request a reporting form.)
Download the FDA warning (.pdf)
Download the updated patient medication guide for Lemtrada
(scroll to bottom of document)
Download the updated prescribing information