Higher Risk of Arrhythmias in Some Patients on Lamictal: FDA

FDA says its review of study findings showed a potential increased risk of heart arrhythmias in patients with heart disease who are taking the seizure and mental health medicine lamotrigine (GlaxoSmithKline’s Lamictal and generics). An agency drug safety communication says FDA wants to evaluate whether other medicines in the same drug class have similar effects on the heart and is requiring safety studies on them too.

The notice says the agency required in vitro studies to further investigate Lamictal’s effects on the heart after receiving reports of abnormal ECG findings and other serious problems.

Lamotrigine has been approved and on the market for more than 25 years, the notice says, and is available in branded and generic versions indicated for use alone or with other medicines to treat seizures in patients aged two years and older. It also may be used as maintenance treatment in patients with bipolar disorder to help delay the occurrence of mood episodes.