Rutgers study challenges FDA warning on antiseizure drug

Rutgers Health researchers found that lamotrigine, a widely prescribed antiseizure medication, to be safe in older adults with epilepsy, contrary to a safety warning by the Food and Drug Administration (FDA).

According to the Centers for Disease Control and Prevention, about 2.9 million adults throughout the United States are living with the neurological disorder.

Lamotrigine, sold under the brand name Lamictal, represents about 10% of all antiseizure medication use. In 2020, the FDA placed a safety warning label on lamotrigine based on reports the drug could increase the risk of heart conditions. As such, patients with epilepsy who may be good candidates for the drug but had a history of heart issues may be precluded from being prescribed this effective treatment modality.

The FDA safety warning, however, came with the caveat that it was based on limited evidence. That prompted Rutgers Health researchers to further analyze the health risks associated with the drug in epilepsy patients.

The FDA's safety warning of lamotrigine may have limited the use of this effective drug in patients with epilepsy. It's important for the public to know that our research found that lamotrigine is safe in older adults with epilepsy, including those with underlying heart disease."

Chintan Dave, senior author of the study, core member of Rutgers Institute for Health, Health Care Policy and Aging Research (IFH), and an assistant professor of pharmacy and epidemiology at the Ernest Mario School of Pharmacy

Chintan Dave, senior author of the study, core member of Rutgers Institute for Health, Health Care Policy and Aging Research (IFH), and assistant professor of pharmacy and epidemiology at the Ernest Mario School of Pharmacy

Their study, published online on June 11 in Neurology, the medical journal of the American Academy of Neurology, examined data from more than 158,000 adults with epilepsy to compare outcomes of two common antiseizure drugs in use, making it the largest study to date analyzing the effects of lamotrigine on cardiac risks in epilepsy patients.

Researchers found no increased risk for heart rhythm problems or sudden cardiac arrest among older adults taking lamotrigine compared to those using the other commonly prescribed antiseizure drug, levetiracetam. Study findings were consistent across a range of subgroups, including age, gender, race and those with histories of heart conditions.

"Our results do not support the FDA safety warning about the use of lamotrigine in patients with heart issues," said Gloria Ho, a visiting scholar at the Center for Pharmacoepidemiology and Treatment Science (PETS) at IFH and a corresponding author of the study.

Study coauthors include Tobias Gerhard of PETS, IFH and the Ernest Mario School of Pharmacy; Daniel Horton of PETS, IFH and Rutgers Robert Wood Johnson Medical School; and Parin Patel of Ascension St. Vincent Heart Center in Indiana.