Lamotrigine & Heart Risk: New Warnings
- New research suggests the antiseizure medication lamotrigine poses no increased cardiac risk for older adults with epilepsy.Two studies published in Neurology examined real-world data, perhaps prompting the Food...
- The FDA issued a warning in 2020 based on in vitro studies and case reports indicating potential arrhythmias in patients with pre-existing heart conditions.
- The results showed no difference in new diagnoses of ventricular tachycardia or ventricular fibrillation between those starting lamotrigine and those starting levetiracetam, another antiseizure drug.
New research presented by News Directory 3 challenges teh FDA’s warning regarding the cardiac safety of lamotrigine, an antiseizure medication. Two recent studies examined the effects of lamotrigine, revealing no increased cardiac risk in older adults. These findings,based on real-world data,may prompt a re-evaluation of the existing safety guidelines for the primary_keyword. The studies compared lamotrigine to another antiseizure drug,levetiracetam,and found no critically important differences in cardiac events,leading researchers to question current warnings about the secondary_keyword. Expert opinions suggest that these studies demonstrate lamotrigine’s safety in clinical practice.Discover what’s next as researchers anticipate further investigations into long-term effects.
Studies Question Cardiac Risk of Epilepsy Drug Lamotrigine
Updated June 15, 2025
New research suggests the antiseizure medication lamotrigine poses no increased cardiac risk for older adults with epilepsy.Two studies published in Neurology examined real-world data, perhaps prompting the Food and Drug Management to re-evaluate its existing safety warning.
The FDA issued a warning in 2020 based on in vitro studies and case reports indicating potential arrhythmias in patients with pre-existing heart conditions. However, clinicians have long prescribed lamotrigine, also known as Lamictal, without widespread evidence of such risks.
One cohort study analyzed U.S. Medicare and U.K. claims data from over 53,000 patients. The results showed no difference in new diagnoses of ventricular tachycardia or ventricular fibrillation between those starting lamotrigine and those starting levetiracetam, another antiseizure drug.
A second study, using Medicare data from nearly 12,000 new lamotrigine users and roughly 150,000 new levetiracetam users, also found no notable difference in the incidence of ventricular arrhythmia and sudden cardiac arrest between the two groups.
Dr. Gloria Y.F. Ho, visiting scholar at Rutgers University and lead author of the second study, said the research was initiated because the FDA’s warning was based on limited evidence. “our study was done in people, had a comparator, and also looked at several subgroups. And we did not find an increased risk” for cardiac outcomes, Ho said.
Lamotrigine accounts for approximately 10% of all antiseizure medication use and remains a first-line treatment for certain types of epilepsy, according to the American Epilepsy Society and the American Academy of Neurology.
The FDA’s 2020 warning cited the drug’s potential to prolong QT interval, induce arrhythmias, and slow ventricular conduction, based on an in vitro study and case reports. Rodent studies also showed prolonged QT intervals with high doses of lamotrigine.
Though, Ho and her colleagues noted that the applicability of these findings to humans was uncertain and that many previous studies lacked the power to detect rare risks. “In such instances, real-world data sources can help provide valuable insights to fill this gap,” they wrote.
The first study, led by Dr. Samuel W. Terman of the university of Calgary, included over 40,000 medicare patients and 13,000 patients from the U.K. The adjusted hazard ratios for ventricular tachycardia/ventricular fibrillation were similar between lamotrigine and levetiracetam users in both datasets.
Ho’s study, focusing on Medicare-insured patients aged 65 and older, showed similar rates of ventricular arrhythmia/sudden cardiac arrest between lamotrigine and levetiracetam users. Secondary analyses revealed no increased risk for those with pre-existing heart conditions.
Ho suggested the FDA warning might limit the use of lamotrigine in patients who could benefit from it. Though, she cautioned that clinicians should still evaluate patients individually, considering other health conditions and medications.
Dr. Leah J. Blank, assistant professor of neurology at the Icahn School of medicine at Mount Sinai, noted that both studies used real-world data and advanced analysis techniques to address safety concerns. “Together, these data suggest that lamotrigine likely is safe in clinical practice and can continue to be used as an effective and well tolerated antiseizure medication,” Blank wrote in an accompanying editorial.
Blank added, ”It’s reassuring that two different groups, using slightly different methods, came to the same conclusion that there is not an increased risk for cardiac events in people taking lamotrigine.”
An FDA spokesperson said the agency does not comment on specific studies but evaluates them as part of the body of evidence to inform its understanding and protect public health. A representative for the American Epilepsy Society said the organization is not currently working on a statement based on these studies.
What’s next
Researchers anticipate further studies to explore the long-term effects of lamotrigine on cardiac health, potentially leading to revised guidelines and treatment protocols for patients with epilepsy.