藥物警訊

Lamictal (lamotrigine): Drug Safety Communication - Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart Disease (1)

[Posted 03/01/2021]

AUDIENCE: Patient, Health Professional, Pharmacy, Neurology, Cardiology, Psychiatry
ISSUE: An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine). FDA wants to evaluate whether other medicines in the same drug class have similar effects on the heart and are also requiring safety studies on those medicines. FDA will update the public when additional information from these studies becomes available.
FDA required these studies, called in vitro studies, to further investigate Lamictal's effects on the heart after FDA received reports of abnormal electrocardiographic (ECG) findings and some other serious problems. In some cases, problems including chest pain, loss of consciousness and cardiac arrest occurred. FDA first added information about this risk to the lamotrigine prescribing information and Medication Guides in October 2020, which has been updated.
BACKGROUND: Lamotrigine is used alone or with other medicines to treat seizures in patients 2 years and older. It may also be used as maintenance treatment in patients with the mental health condition bipolar disorder to help delay the occurrence of mood episodes such as depression, mania, or hypomania. 
RECOMMENDATION: 
Patients should not stop taking your medicine without first talking to your prescriber because stopping lamotrigine can lead to uncontrolled seizures or new or worsening mental health problems. Contact your health care professional right away, or go to an emergency room if you experience an abnormal heart rate or irregular rhythm, or symptoms such as a racing heartbeat, skipped or slow heartbeat, shortness of breath, dizziness, or fainting.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/WEQxq5
Lamictal（lamotrigine）可單獨使用或與其他藥物併用於治療2歲(含)以上的癲癇發作。此藥亦可用於雙極性疾患(bipolar disorder)之維持治療，以幫助延緩諸如抑鬱症、躁鬱症或輕躁症等狀況發生。美國FDA回顧研究結果顯示，心臟疾病患者服用治療癲癇相關藥物Lamictal（lamotrigine）可能會增加心律不整的風險。美國FDA希望評估同一類的其他藥品是否亦會對心臟產生相似的副作用，因此要求這些藥品需進行安全性研究。若有進一步的研究結果，美國FDA將會向大眾更新。
美國FDA收到心電圖(ECG)異常和一些其他嚴重問題(包括胸痛、意識喪失和心臟驟停)的通報後，要求進行體外研究，以進一步調查Lamictal對心臟的影響。並於2020年10月於lamotrigine的仿單和用藥指引中更新了此訊息。
病人在未先與處方醫師討論前，不應停止服藥，因停藥會導致無法控制癲癇發作或產生惡化心理健康問題。若遇到異常的心跳或不規則的節律、出現心跳加快、心跳過慢、呼吸急促、頭暈或暈倒等症狀，請立即與醫療專業人員聯繫或至急診就醫。
（待續）
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