New Studies Challenge FDA Warning: Lamotrigine Safe for Older Adults With Epilepsy

June 13, 2025
New Studies Challenge FDA Warning: Lamotrigine Safe for Older Adults With Epilepsy
  • Similarly, a second cohort study involving nearly 12,000 lamotrigine users and 150,000 levetiracetam users reported no significant differences in incidences of ventricular arrhythmia and sudden cardiac arrest.

  • In 2020, the FDA issued a safety warning regarding lamotrigine, citing concerns that it could increase the risk of heart conditions, particularly in patients with pre-existing heart issues.

  • Lead researcher Gloria Y.F. Ho highlighted that their real-world data provided insights that contradicted the FDA's initial concerns.

  • The first cohort study analyzed over 53,000 patients and found no significant difference in new diagnoses of ventricular tachycardia or ventricular fibrillation between lamotrigine and levetiracetam users.

  • Importantly, no increased risk for ventricular arrhythmia or sudden cardiac arrest was found even in patients with a history of heart disease, which was a key concern of the FDA warning.

  • It's worth noting that the findings may not apply to younger patients or those without epilepsy, as the studies primarily focused on individuals aged 65 and older.

  • However, recent studies have challenged this warning, indicating that lamotrigine does not increase cardiac risk in older adults with epilepsy.

  • This warning was based on limited evidence, including in vitro studies and case reports of arrhythmias, which may not accurately reflect human physiology.

  • Lamotrigine, marketed as Lamictal, is a widely used first-line therapy for certain types of epilepsy, accounting for about 10% of all antiseizure medication prescriptions in the United States.

  • The studies were co-authored by researchers including Gloria Ho, Tobias Gerhard, Daniel Horton, and Parin Patel, enhancing the credibility of the findings.

  • An accompanying editorial reinforced that lamotrigine appears to be safe and effective, aligning with the conclusions of both research teams.

  • Currently, approximately 2.9 million adults in the U.S. are living with epilepsy, making the safety and efficacy of lamotrigine a significant concern.

Summary based on 2 sources


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