Rutgers Study Questions FDA Safety Warning on Lamotrigine for Epilepsy in Older Adults

Recent research conducted by Rutgers Health has provided new insights into the safety profile of lamotrigine, a widely used antiseizure medication also known as Lamictal. Contrary to a safety warning issued by the Food and Drug Administration (FDA) in 2020, which suggested potential risks of heart complications, the study found that lamotrigine is safe for older adults with epilepsy, including those with underlying heart conditions.

Published in the journal Neurology, the study analyzed data from over 158,000 adults diagnosed with epilepsy, making it the largest investigation to date on the cardiac effects of lamotrigine in this patient population. The researchers compared outcomes between patients taking lamotrigine and those prescribed levetiracetam, another common antiseizure drug. Their findings revealed no increased risk of cardiac rhythm problems or sudden cardiac arrest among older patients using lamotrigine.

Chintan Dave, a senior author of the study and an expert in pharmacy and epidemiology at Rutgers, emphasized that the earlier FDA warning was based on limited evidence, which potentially limited patient access to an effective medication. The new findings suggest that lamotrigine is a safe option for managing epilepsy in older individuals, even those with a history of heart disease.

The study's results were consistent across various subgroups, including different ages, genders, races, and those with pre-existing cardiac conditions. This evidence challenges the FDA’s earlier safety concerns and indicates that lamotrigine can be confidently prescribed to a broader range of patients.

Researchers hope their findings will influence future clinical guidelines and reassure healthcare providers and patients about the safety of lamotrigine. The study was led by experts including Gloria Ho, Tobias Gerhard, Daniel Horton, and Parin Patel. For more details, see the publication in Neurology (2025), DOI: 10.1212/WNL.0000000000213643.

Source: https://medicalxpress.com/news/2025-06-fda-common-epilepsy-drug.html