FDA Warns Lamotrigine May Cause Arrhythmias in Persons with Heart Disease

April 2, 2021

Healthcare providers are advised to weigh carefully the risks vs benefits of continuing lamotrigine therapy and not to substitute with another drug from the class.

The US Food and Drug Administration this week warned that individuals with heart disease who take the anticonvulsant lamotrigine may be at increased risk for dangerous cardiac arrhythmias.

The Drug Safety Communication was issued after an FDA review of reports of abnormal electrocardiograph (ECG) findings and other serious issues including chest pain, loss of consciousness, and cardiac arrest.

The agency is currently reviewing other medications in the class of sodium channel blockers and requiring that manufacturers conduct safety studies.

Lamotrigine is indicated as monotherapy or adjunctive therapy for the treatment of epilepsy. It is also approved for use as maintenance treatment in patients with bipolar I disorder.

During laboratory testing performed at therapeutically relevant concentrations, according to the Safety Communication, lamotrigine was found to increase the risk of serious and potentially life-threatening arrhythmias in patients with clinically important structural or functional heart disorders (eg, 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 Agency is recommending that health care professionals evaluate whether the benefits of lamotrigine outweigh the potential risk of arrhythmias for each patient.

The statement further warns that the concomitant use of lamotrigine with other sodium channel blockers may further increase the risk of arrhythmias. In the safety communication, the Agency stated that “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.”

Lamotrigine has been approved and on the market for more than 25 years and is available under the brand name Lamictal and as generics.

Source: US Food and Drug Administration. Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease. News release. March 31, 2021.