Rutgers Study Challenges FDA Heart Safety Warning for Epilepsy Drug Lamotrigine
Key Insights
Rutgers Health (search) researchers found lamotrigine safe in older adults with epilepsy (search), contradicting a 2020 FDA safety warning about potential heart risks.
The study analyzed data from over 158,000 adults with epilepsy (search), making it the largest investigation to date of lamotrigine's cardiac effects.
Researchers found no increased risk for heart rhythm problems (search) or sudden cardiac arrest (search) compared to levetiracetam, even in patients with existing heart conditions (search).
Rutgers Health (search) researchers have published findings that challenge a Food and Drug Administration (search) safety warning on lamotrigine, a widely prescribed antiseizure medication. The study, published online on June 11 in Neurology, found the drug to be safe in older adults with epilepsy (search), including those with underlying heart disease.
Large-Scale Safety Analysis
The research examined data from more than 158,000 adults with epilepsy (search), making it the largest study to date analyzing the effects of lamotrigine on cardiac risks in epilepsy patients. Researchers compared outcomes between patients taking lamotrigine and those using levetiracetam, another commonly prescribed antiseizure drug.
"The FDA's safety warning of lamotrigine may have limited the use of this effective drug in patients with epilepsy (search)," said Chintan Dave, senior author of the study and core member of Rutgers Institute for Health (search), Health Care Policy and Aging Research. "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."
FDA Warning Background
In 2020, the FDA placed a safety warning label on lamotrigine, sold under the brand name Lamictal, based on reports the drug could increase the risk of heart conditions (search). The warning came with the caveat that it was based on limited evidence. Lamotrigine represents about 10% of all antiseizure medication use, and the warning potentially precluded patients with epilepsy (search) who had a history of heart issues from being prescribed this treatment option.
According to the Centers for Disease Control and Prevention (search), about 2.9 million adults throughout the United States are living with epilepsy (search).
Study Findings
Researchers found no increased risk for heart rhythm problems (search) or sudden cardiac arrest (search) among older adults taking lamotrigine compared to those using levetiracetam. The study findings were consistent across a range of subgroups, including age, gender, race and those with histories of heart conditions (search).
"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 at the Rutgers Institute for Health (search) and corresponding author of the study.
Research Team
The study was conducted by researchers from multiple Rutgers departments. Study coauthors include Tobias Gerhard of the Center for Pharmacoepidemiology and Treatment Science, the Institute for Health, and the Ernest Mario School of Pharmacy (search); Daniel Horton of the same departments and Rutgers Robert Wood Johnson Medical School; and Parin Patel of Ascension St. Vincent Heart Center in Indiana.