Lamotrigine Associated with Potential for Irregular Heartbeat

March 31, 2021 – The U.S. FDA has issued a safety communication for lamotrigine, a drug used to treat seizures and bipolar disorder. The product is available as a generic and under the brand name Lamictal® (GlaxoSmihKline).

Based on a review of study findings, the FDA has determined that there is a potential for increased risk of heart rhythm problems (arrhythmias) associated with the use of lamotrigine in patients who have heart disease. Studies were conducted after the FDA received reports of abnormal electrocardiograph findings and problems including chest pain, loss of consciousness, and cardiac arrest in patients taking lamotrigine. Information regarding the potential risks has been added to the drug’s prescribing information and Medication Guide. In addition, the FDA plans to investigate whether other medications in the same drug class affect the heart in a similar manner.

The agency advises patients to consult their healthcare provider before stopping lamotrigine. Stopping treatment could lead to uncontrolled seizures or new or worsening mental health problems. The FDA cautions that patients should go to the emergency room immediately if they 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. For healthcare providers, the FDA recommends that they consider the risk versus the benefit of lamotrigine for each individual patient.

A full copy of the safety warning is available on the FDA’s website.