[FDA Drug Safety Communication, March 31, 2021] – The U.S. Food and Drug Administration (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 lamotrigine. The agency is now requiring studies to evaluate heart risk across the drug class.
The review followed reports of abnormal electrocardiographic (ECG) findings and some other serious problems (including chest pain, loss of consciousness, and cardiac arrest) associated with lamotrigine.
Health care professionals should assess whether the potential benefits of lamotrigine outweigh the potential risk of arrhythmias for each patient. In vitro testing performed at therapeutically relevant concentrations showed that lamotrigine can increase the risk of serious arrhythmias, which can be life-threatening, in patients with clinically important structural or functional heart disorders (e.g., 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.
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