NPRA Alerts on Lamotrigine Safety Risk

On 17 September 2025, the National Pharmaceutical Regulatory Agency (NPRA) released a safety signal alert concerning the anticonvulsant drug lamotrigine. The alert highlights the potential risk of erythema multiforme (EM), an immune-mediated skin reaction. While lamotrigine is commonly prescribed for epilepsy and mood disorders, this new safety signal underscores the importance of vigilance in both clinical practice and patient monitoring.

Erythema multiforme is an acute skin condition that is often triggered by infections or medications. It presents with distinctive “target-like” lesions on the skin and, in some cases, can affect the mucous membranes. Although EM is generally self-limiting, it requires prompt recognition and management to prevent progression into more severe conditions. The NPRA’s alert is intended to raise awareness of this risk and to encourage healthcare professionals to carefully monitor patients.

In Malaysia, studies have shown an increasing incidence of severe cutaneous adverse reactions (SCARs) associated with antiseizure medications, including lamotrigine. Historical research in local hospitals has also identified antiepileptic drugs as a common trigger for skin reactions such as EM. While the NPRA has not released the exact number of cases linked to lamotrigine, the alert is part of the agency’s ongoing pharmacovigilance efforts to safeguard patient health.

For healthcare professionals, this alert serves as a reminder to educate patients on early warning signs such as unusual rashes, target lesions, or skin discomfort, particularly during the first weeks of therapy. Prompt reporting of suspected adverse reactions to NPRA is essential in strengthening Malaysia’s safety monitoring system. Patients are encouraged not to discontinue treatment on their own, but to seek medical advice if they notice any changes in their skin condition.

From a regulatory perspective, the safety signal does not equate to a ban or restriction of lamotrigine. Instead, it highlights the need for proactive risk management by manufacturers, healthcare providers, and patients alike. NPRA may issue further guidance in the future, such as updates to product information or additional monitoring requirements, depending on the evidence collected.

This latest alert is a reminder of the critical role of pharmacovigilance in protecting public health. Continuous reporting, awareness, and collaboration between regulators and the healthcare community are key to ensuring that essential medicines remain both effective and safe for the population.

Source: National Pharmaceutical Regulatory Agency (NPRA)