[Posted 03/31/2021]
Lamictal (lamotrigine): Drug Safety Communication - Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart Disease (2)
Health care professionals should assess whether the potential benefits of lamotrigine outweigh the potential risk of arrhythmias for each patient. Laboratory testing performed at therapeutically relevant concentrations has shown that lamotrigine can increase the risk of serious arrhythmias, which can be life-threatening in patients with clinically important structural or functional heart disorders. Clinically important structural and functional heart disorders include heart failure, valvular heart disease, congenital heart disease, conduction system disease, ventricular arrhythmias, cardiac channelopathies such as Brugada syndrome, clinically important ischemic heart disease, or multiple risk factors for coronary artery disease. The risk of arrhythmias may increase further if used in combination with other medicines that block sodium channels in the heart. Other sodium channel blockers approved for epilepsy, bipolar disorder, and other indications should not be considered safer alternatives to lamotrigine in the absence of additional information.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/WEQxq5
醫事專業人員應評估每位病人lamotrigine的潛在益處是否超過潛在發生心律不整的風險。在實驗室測試顯示，治療濃度下的lamotrigine可能增加嚴重心律不整的風險，特別是有臨床上重要結構或功能性心臟病的患者可能會危及生命。臨床上重要的結構性和功能性心臟病包括心衰竭、瓣膜性心臟病、先天性心臟病、傳導系統疾病、心室心律不整、Brugada症候群等心臟離子通道疾病、臨床上重要的缺血性心臟病或多種危險因子之冠狀動脈心臟病。若與其他阻斷心臟鈉離子通道的藥物合併使用，心律不整的風險可能會增加。其他核可用於癲癇、雙極性疾患和其他適應症之鈉離子通道阻斷劑在沒有更多資訊的情況下，不應作為lamotrigine的安全替代品。（全文完）
更多相關訊息與連結請參考FDA網址：https://reurl.cc/WEQxq5
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
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