The Food and Drug Administration (FDA) has added a black box warning for alemtuzumab (Lemtrada) stating that the drug, used in the treatment of relapsing multiple sclerosis (MS), may cause ischemic and hemorrhagic stroke and cervicocephalic arterial dissection, rare but serious adverse effects. Thirteen worldwide cases (10 in the United States and three in Europe) of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection (tears in the lining of the arteries in the head and neck) have been reported to the FDA's Adverse Event Reporting System since 2014, the year Lemtrada was approved. Twelve of the 13 cases occurred within one day, and the other within three days, of receiving alemtuzumab. These case reports prompted the FDA to add these risks to the black box warning on the drug's labeling and to include information about them in the patient medication guide. Alemtuzumab is also approved under the trade name Campath for treatment of B-cell chronic lymphocytic leukemia. Some cases of ischemic stroke and intracerebral hemorrhage have been reported for Campath. The black box warning for Lemtrada will be added to the Campath labeling as well.
Alemtuzumab for MS is given as an intravenous infusion and is only available through the FDA's risk evaluation and mitigation strategy (REMS) program. Alemtuzumab has always been available only through the REMS program because it can cause other serious adverse effects, including autoimmune problems, infusion reactions, and some cancers.
Although these adverse effects are rare, nurses should teach patients who receive alemtuzumab and their families about the symptoms of stroke. These include
* numbness or weakness in the face, arms, or legs.
* confusion, trouble speaking, or difficulty understanding speech.
* trouble seeing in one or both eyes.
* difficulty walking, dizziness, or loss of balance or coordination.
* severe headache or neck pain.
If any of these symptoms occur suddenly, the patient should seek immediate emergency medical care. To read the FDA Drug Safety Communication, go to http://www.fda.gov/Drugs/DrugSafety/ucm624247. htm.