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December 1, 2018FDA Issues Lemtrada Safety Alert
November 29, 2018 – Patients with multiple sclerosis (MS) who are treated with Lemtrada® (alemtuzumab) may be at risk for rare but serious cases of stroke, as well as tears in the lining of arteries (arterial dissection) located in the head and neck. These events can lead to death or permanent disability. In most instances, patients developed symptoms within one day of receiving Lemtrada.
First approved in 2014 and manufactured by Genzyme, Lemtrada already carries an indication that warns its use should be reserved for patients who have had an inadequate response to two or more drugs approved for the treatment of MS. A black box warning cautions that Lemtrada can cause serious and potentially fatal autoimmune conditions and infusion reactions, and may increase a patient’s risk of cancer. The FDA is adding risk of stroke to the black box warning, with additional warnings included in the "Warnings and Precautions" section of the prescribing information. A warning has also been added to the Medication Guide for Lemtrada.
Healthcare providers should advise patients at every infusion of the risks associated with Lemtrada. Patients and caregivers should seek emergency medical help immediately if the patient exhibits signs of stroke or arterial dissection. These include:
- Sudden numbness or weakness in the face, arms, or legs, especially 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; and/or
- Sudden severe headache or neck pain.
The active ingredient in Lemtrada, alemtuzumab, is also approved under the brand name Campath® to treat certain patients who have B-cell chronic lymphocytic leukemia (B-CLL). Approved in 2001 and manufactured by Genzyme, Campath will receive updates to its drug label to reflect the risk of stroke and arterial dissection in patients with MS. These updates will be included under “Adverse Reactions” in the “Postmarketing Experience” section of the label.
