FDA Warns of Stroke Risk With Taking MS Drug Lemtrada

The U.S. Food and Drug Administration is warning multiple sclerosis patients that the drug Lemtrada may increase their risk of having a stroke and creating tears in blood vessel walls.

Lemtrada (alemtuzumab) is a multiple sclerosis drug used to treat relapsing forms of the autoimmune disease.

The drug, which was approved in 2014, is injected through an IV and has previously been associated with infusion reactions (breathing problems, chest pain, rash), serious autoimmune complications, and certain cancers (thyroid cancer, melanoma, lymphoma).

Due to Lemtrada’s safety profile, the drug is typically only prescribed to patients who have not responded to two or more other MS medications. However, the drug’s safety profile may be taking another hit with recent warnings against life-threatening complications.

In November 2018, the FDA announced that Lemtrada may be associated with rare but severe complications including stroke and arterial tears. According to the agency, these complications can lead to permanent disability and even death.

A stroke occurs when blood flow to the brain is cut off or when bleeding in the brain deprives brain cells of blood flow and oxygen. Tears in the arteries of the head and neck are called arterial dissections and may lead to a stroke.

Since Lemtrada’s approval in 2014, the FDA reportedly identified 13 cases around the world of ischemic and hemorrhagic stroke or arterial dissection which occurred in Lemtrada patients shortly after the drug was administered.

In some patients, the symptoms of stroke or arterial dissection developed within one day. In one patient, symptoms took three days to appear. One patient who suffered from a hemorrhagic stroke died.

The FDA notes that, although only 13 cases were reported, there may have been additional cases that were not reported.

As a result of the discovered risks, the FDA has added warnings to Lemtrada’s drug label and patient medication guide. The agency has also added a boxed warning, its most prominent warning, to inform patients about the risk of stroke.

The FDA encourages multiple sclerosis patients to monitor for signs and symptoms including: sudden numbness or weakness in the face, arms, or legs; 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 sudden severe headache or neck pain. These symptoms could be a sign of stroke or arterial dissection in the neck or head, both of which require prompt medical attention.

Multiple sclerosis is an autoimmune condition that affected the central nervous system. In patients with multiple sclerosis, the body attacks the myelin sheaths that insulate nerve cells in the brain and spinal cord. Because myelin sheaths help conduct neurological signals, the deterioration of these structures can cause a wide variety of symptoms including fatigue, visual disturbances, altered sensation, and mobility problems. However, symptoms may vary depending on which neurological connections are compromised.

Health care professionals are advised to inform multiple sclerosis patients about the risks of treatment with Lemtrada and monitor for any signs of stroke or arterial dissection.

Although early symptoms like a headache or neck pain may not be specific, the FDA encourages health care professionals to promptly evaluate Lemtrada patients with these issues.