FDA orders more research into arrhythmia risk with Lamictal, other antiseizure drugs

The FDA ordered additional studies for Lamictal following a review of current research by the agency that demonstrated the potential for an increased risk for arrhythmias in patients with heart disease who are taking Lamictal.

Lamictal (lamotrigine, GlaxoSmithKline) is used alone or in combination with other agents to treat seizures in patients aged 2 years and older. The FDA order for additional studies of Lamictal will require further investigation into the drug’s effect on the heart after the agency received reports of abnormal EEG findings and “some other serious problems,” according to a press release, including chest pain, loss of consciousness and cardiac arrest. The FDA first added information about these issues in October 2020.

The agency also ordered studies on other agents in the same drug class, including lacosamide, which recently received expanded approval as adjunctive therapy for primary tonic-clonic seizures as well as an IV formulation for patients aged 4 years and older.

Additional agents requiring further studies include:

• carbamazepine,
• cenobamate (XCOPRI, SK Biopharmaceuticals),
• eslicarbazepine (Aptiom, Sunovion]),
• fosphenytoin,
• oxcarbazepine,
• phenytoin,
• rufinamide (Banzel, Eisai),
• topiramate, and
• zonisamide.

The statement from the FDA directs health care professionals to examine the benefits of Lamictal and weigh those against the risk for arrythmia for individual patients. It also notes that other sodium channel blockers used for epilepsy, bipolar disorder and other conditions “should not be considered safer alternatives to lamotrigine in the absence of additional information.”

The agency “will update the public when additional information from these studies becomes available,” according to the press release.

Reference:

FDA. Lamictal (lamotrigine): Drug safety communication - studies show increased risk of heart rhythm problems in patients with heart disease. Available at: https://www.fda.gov/safety/medical-product-safety-information/lamictal-lamotrigine-drug-safety-communication-studies-show-increased-risk-heart-rhythm-problems. Accessed April 1, 2021.