In a groundbreaking revelation, researchers from Rutgers Health have challenged a crucial safety warning issued by the FDA regarding lamotrigine, a widely-used medication for epilepsy. This study, recently published in the journal Neurology, indicates that the drug is indeed safe for older adults suffering from epilepsy.

With approximately 2.9 million adults grappling with this neurological disorder in the U.S., lamotrigine (marketed under the brand name Lamictal) represents around 10% of all antiseizure medication use. Historically, the FDA slapped a safety warning label on lamotrigine due to concerns it might elevate the risk of heart conditions, preventing many patients from accessing this effective treatment.

However, the FDA's caution was based on limited evidence, which prompted Rutgers Health researchers to dive deeper into the drug's impact on epilepsy patients. Senior study author Chintan Dave, affiliated with the Rutgers Institute for Health, Health Care Policy and Aging Research, stated, "The FDA's safety warning may have unnecessarily restricted this effective drug's use among epilepsy patients." He emphasized that their research confirmed lamotrigine is indeed safe, even for those with heart disease.

The extensive analysis covered data from over 158,000 adults with epilepsy, making it the largest study of its kind to assess lamotrigine's cardiac risks. The findings revealed no significant increase in heart rhythm disturbances or sudden cardiac arrest in older adults taking lamotrigine compared to those on the commonly prescribed alternative, levetiracetam.

Result consistency crossed various demographics, including age, gender, race, and existing heart issues. Co-author Gloria Ho noted, "Our results do not align with the FDA's safety warning related to lamotrigine in patients with heart concerns." This crucial data could reshape how lamotrigine is perceived and prescribed, potentially improving the lives of countless individuals affected by epilepsy.

The study included contributions from notable scholars such as Tobias Gerhard and Daniel Horton from Rutgers, as well as Parin Patel from Ascension St. Vincent Heart Center. Their collective efforts underscore the importance of reevaluating safety warnings based on robust research.