A recent study conducted by researchers at Rutgers University has thrown doubt on a safety warning issued by the U.S. Food and Drug Administration (FDA) regarding a commonly used antiepileptic drug, sparking a significant discussion within the medical community.
According to data from the Centers for Disease Control and Prevention, approximately 2.9 million adults in the United States suffer from epilepsy, a neurological disorder. Lamotrigine, sold under the brand name Lamictal, is one of the most widely prescribed antiepileptic medications, accounting for around 10% of all antiepileptic drug usage. In 2020, the FDA added a safety warning to the drug’s label, stating that lamotrigine might increase the risk of heart diseases. This warning has led to many epilepsy patients with a history of heart disease, who could potentially benefit from the drug, being excluded from this effective treatment option. However, it’s important to note that the FDA’s warning was based on limited evidence.
To further investigate the health risks of this drug among epilepsy patients, Rutgers University researchers delved deeper. Published online on June 11 in Neurology, the medical journal of the American Academy of Neurology, the study examined data from more than 158,000 adult epilepsy patients and compared the therapeutic effects of two commonly used antiepileptic drugs. This is also the largest study to date analyzing the impact of lamotrigine on the heart risks of epilepsy patients. “The FDA’s safety warning on lamotrigine may have limited the use of this effective drug among epilepsy patients. It’s crucial for the public to know that our research found lamotrigine to be safe in older epilepsy patients, including those with underlying heart diseases,” said Chintan Dave, the study’s senior author, a core member of the Institute for Health, Health Care Policy and Aging Research (IFH) at Rutgers University, and an assistant professor of pharmacy and epidemiology at the Ernest Mario School of Pharmacy.
The study results showed that older adults taking lamotrigine did not have an increased risk of arrhythmia problems or cardiac arrest compared to those using levetiracetam, another commonly used antiepileptic drug. Moreover, the findings remained consistent across a range of subgroups, including age, gender, race, and those with a history of heart disease. “Our results do not support the FDA’s safety warning on the use of lamotrigine in patients with heart problems,” noted Gloria Hoh, a visiting scholar at the Center for Pharmacoepidemiology and Therapeutic Science (PETS) at Rutgers University’s IFH and the study’s corresponding author.
The study’s co-authors also include Tobias Gerhard from PETS, IFH, and the Ernest Mario School of Pharmacy; Daniel Horton from PETS, IFH, and the Rutgers Robert Wood Johnson Medical School; and Parin Patel from the Ascension St. Vincent Heart Center in Indiana. This research provides clinicians with new references when treating epilepsy patients and has triggered further discussions on the rationality of the FDA’s drug safety warning. With the deepening of future research, it is expected to bring more positive changes to the field of epilepsy treatment.
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