A new study indicates that lamotrigine, a frequently prescribed antiseizure medication, is safe for older adults with epilepsy, challenging a prior safety warning issued by the Food and Drug Management (FDA). The research, conducted by scientists at rutgers Health, suggests the drug does not elevate the risk of heart conditions in this population.

Epilepsy,a neurological disorder,affects approximately 2.9 million adults in the United States, according to the Centers for Disease Control and Prevention.

Lamotrigine, also known as Lamictal, accounts for about 10% of all antiseizure medications prescribed. In 2020, the FDA issued a safety warning for lamotrigine, citing reports suggesting it could increase the risk of heart problems.This warning potentially limited the use of the drug for epilepsy patients with pre-existing heart conditions.

Though, the FDA’s warning acknowledged that it was based on limited evidence, prompting further investigation by researchers at Rutgers Health to assess the actual health risks associated with lamotrigine in epilepsy patients.

Lamotrigine’s Safety profile examined

Chintan Dave, a senior author of the study, a 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, stated, “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.”

“Our results do not support the FDA safety warning about the use of lamotrigine in patients with heart issues.”

The study, published in Neurology, the medical journal of the American Academy of Neurology, analyzed data from over 158,000 adults with epilepsy. It compared the outcomes of lamotrigine with those of another common antiseizure drug, making it the largest study to date to analyze the cardiac risks associated with lamotrigine in epilepsy patients.

The researchers found no increased risk of heart rhythm problems or sudden cardiac arrest in older adults taking lamotrigine compared to those taking levetiracetam.These findings remained consistent across various subgroups, including different ages, genders, races, and individuals with pre-existing heart conditions.

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

Other contributors to the study 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.