FDA Lemtrada Warning

Lemtrada (alemtuzumab), a multiple sclerosis medicine with a severe safety profile, is the subject of a new FDA Lemtrada Stroke Warning. Issued in late 2018, the FDA Lemtrada Stroke Warning is the culmination of adverse event reports collected by FAERS (the Federal Adverse Event Reporting System), documenting a trend of patients suffering arterial dissection and stroke shortly after first taking Lemtrada. In light of the Lemtrada FDA Warning, drug safety experts are now questioning whether the benefits of this drug still outweigh its risks. This page provides comprehensive information on the FDA Lemtrada stroke warning from attorneys providing Lemtrada lawsuit representation for individuals and families nationwide.

Black Box FDA Lemtrada Warning

In November of 2018, the FDA Lemtrada Warning was issued, adding yet another Black Box Warning to the already fraught drug. The warning states that Lemtrada carries a risk of "rare but serious" reactions to the drug including arterial dissection and ischemic or hemorrhagic stroke. Between the time Lemtrada was first approved in 2014 and the release of the FDA Lemtrada warning, thirteen cases of ischemic or hemorrhagic stroke and/or arterial dissection as a reaction to Lemtrada were reported worldwide to the adverse event reporting system. Ten of these cases took place in the United States; three more occurred in Europe. One of the thirteen cases was fatal. The FDA notes that this tally includes only the cases reported to the FAERS system, and that "additional cases we are unaware of may have occurred".

The Lemtrada label already features a Black Box Warning (the strictest level of warning issued by the FDA) for serious, sometimes fatal autoimmune conditions, serious and life-threatening infusion reactions, and an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders. The new FDA Lemtrada stroke warning adds yet another severe side effect of the drug to the list of Black Box warnings.

FDA Lemtrada Warning for Arterial Dissection

Arterial dissection is a severe and life-threatening condition that occurs when tears suddenly develop in the lining of the arteries in the head and neck. As a small tear increases in size, a pouch known as a "false lumen" forms. Blood collects in the false lumen, which can then block blood flow and cause a stroke. According to the FDA Lemtrada Warning, arterial dissection typically occurs in the first day a patient begins taking the drug, though it may occur within the first three days. Vague early signs of arterial dissection (head and neck pain) make this condition difficult to diagnose before it has reached an advanced stage.

FDA Lemtrada Stroke Warning

Lemtrada stroke is caused by arterial dissection. Ischemic stroke occurs when the blood supply to the brain is cut off. Brain cells that lack oxygen can start to die within minutes. Hemorrhagic stroke occurs when there is bleeding on the brain. Lemtrada has caused both hemorrhagic and ischemic stroke, according to the FDA warning.

FDA Lemtrada History

Lemtrada was first approved in 2014 to treat a particular form of multiple sclerosis known as relapsing MS. Initial concerns about Lemtrada risks led federal regulators to require the establishment of a comprehensive risk evaluation and mitigation strategy (REMS) to ensure serious Lemtrada risks be managed. In addition, this drug was recommended as a last resort, due to its dangerous safety profile. Physicians typically prescribe the drug only when alternative treatments fail. Furthermore, because Lemtrada is administered intravenously and may cause severe infusion reactions, it can only be administered in specific clinical settings that are prepared to respond rapidly to anaphylaxis or another life-threatening infusion reaction.

Alemtuzumab (the generic name for Lemtrada) is also available as Campath, which is approved to treat B-cell chronic lymphocytic leukemia. The FDA reported in late 2018 that cases of ischemic stroke and intracerebral hemorrhage have also occurred in patients taking the substance to treat leukemia. Further research on the link between Lemtrada and stroke is underway.

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Lemtrada Stroke Lawsuits

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