Drug Safety Communication

If your email program has trouble displaying this email, view as a webpage.

US Food and Drug Administration

Drug Safety Communication

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 lamotrigine (Lamictal).  We want to evaluate whether other medicines in the same drug class have similar effects on the heart and are requiring safety studies on those also.  We 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 we 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.  In vitro studies are studies done in test tubes or petri dishes and not in people or animals.  We first added information about this risk to the lamotrigine prescribing information and Medication Guides in October 2020, which we have updated.

Read More