Researchers at Rutgers University-New Brunswick (N.J.) are questioning the FDA’s 2020 decision to place a safety warning on a common antiseizure medication.
Lamictal (lamotrigine), a GSK medicine approved to treat epilepsy and bipolar disorder, accounts for about 10% of all antiseizure medication use, according to a June 10 news release from Rutgers University. In 2020, the FDA added a warning to its label, saying, “Based on in vitro findings, Lamictal could cause serious arrhythmias and/or death in patients with certain underlying cardiac disorders or arrhythmias.”
Four researchers at Rutgers University-New Brunswick and a cardiologist at St. Louis-based Ascension called this decision into question after examining data from nearly 160,000 patients. The patients were Medicare-insured adults aged 65 or older with epilepsy taking either Lamictal or levetiracetam, another common antiseizure drug, between 2007 and 2019.
Among the 11,786 patients taking Lamictal, there was no increased risk for ventricular arrhythmia and sudden cardiac arrest compared to levetiracetam, the study found. Additionally, there was no increased risk associated with age, gender, race and history of heart conditions.
The researchers published their results June 11 in Neurology. In a news release, study authors said the FDA’s safety warning might have limited the drug’s use in patients with epilepsy and heart issues.
