FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab). These problems can lead to permanent disability and even death. As a result, we have added a new warning about these risks to the prescribing information in the drug label and to the patient Medication Guide. We have also added the risk of stroke to the existing Boxed Warning, FDA's most prominent warning.
Alemtuzumab is also approved under the brand name Campath, which was approved in May 2001 to treat a type of cancer called B-cell chronic lymphocytic leukemia (B-CLL). The Campath drug label will also be updated to include these risks in the Adverse Reactions section under Postmarketing Experience.
Patients or their caregivers should seek emergency treatment as soon as possible if the patient experiences signs or symptoms of a stroke or tears in the lining of the head and neck arteries, called arterial dissection, which can include:
．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
Most patients taking Lemtrada who developed stroke or tears in the artery linings, developed symptoms within 1 day of receiving Lemtrada. One patient reported symptoms that occurred 3 days after treatment.
Health care professionals should advise patients at every Lemtrada infusion to seek immediate emergency medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. The diagnosis is often complicated because early symptoms such as headache and neck pain are not specific. Promptly evaluate patients who complain of symptoms consistent with these conditions.
In the nearly five years since FDA approved Lemtrada in 2014 to treat relapsing forms of MS, we identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada (see Data Summary). This number includes only reports submitted to FDA,* so additional cases we are unaware of may have occurred. Twelve of these cases reported symptoms within 1 day of receiving Lemtrada. As a result, we have added a new warning about this risk in the Warnings and Precautions section of the prescribing information in the drug label. We have also added the risk of stroke to the existing Boxed Warning, FDA's most prominent warning.
美國FDA發布藥物安全警訊，在患有多發性硬化症(multiple sclerosis, MS)的病人使用Lemtrada (alemtuzumab)之後不久，出現罕見但嚴重的不良反應：中風和頭頸部動脈內層剝離。這些不良反應可能導致永久性殘疾，甚至死亡。自美國FDA於2014年核准Lemtrada治療復發型MS以來，共接獲全球13個案例在使用Lemtrada後不久出現缺血性和出血性中風或動脈剝離。此數字僅包括提供給美國FDA的通報，亦可能有其他更多美國FDA不知道的案例發生。其中12例在接受Lemtrada後1天內出現症狀。因此，美國FDA於藥品仿單和病人用藥指南中加入此新的藥物安全警訊，並於現有的加框警語中增加可能導致中風的風險。
Alemtuzumab也以Campath商品名於2001年5月美國FDA核准上市，用於治療B細胞慢性淋巴白血病（B-cell chronic lymphocytic leukemia, B-CLL）。Campath之藥品仿單也將在上市後之不良反應中註明此風險。
若病人出現中風或頭頸部動脈剝離的跡象或症狀，應盡快就醫，其症狀包含：
． 臉、手臂或腿部突然麻木或沒力，特別是僅有身體一側出現時
． 突然混亂、說話困難或言語難以理解
． 一眼或雙眼在視力上突然出現問題
． 行走困難，頭暈或失去平衡或協調
． 突然劇烈頭痛或頸部疼痛
大多數出現中風或動脈剝離之病人，是使用Lemtrada後1天內出現症狀；1名病人則是於治療後3天出現症狀。
醫療專業人員應於每次輸注Lemtrada時告知病人，如果病人出現缺血性或出血性中風或頸部動脈剝離症狀，需立即就醫。此問題通常診斷很複雜，因為頭痛和頸部疼痛等早期症狀未有特殊性。如病人主訴有包含以上相關症狀，應立即評估。
相關訊息與其他完整的建議請參考FDA網址：https://www.fda.gov/Drugs/DrugSafety/ucm624247.htm?utm_campaign=FDA%20MedWatch%20-%20Lemtrada%20%28alemtuzumab%29%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
[Posted 11/29/2018]
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