NAFDAC Halts Registration Of Multi-Dose Anti-Malarial Suspension Artemether/Lumefantrine.
The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the discontinuation of the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension. The decision, detailed in Public Alert No. 01/2025 published on the agency’s website on Thursday, comes after evidence revealed instability in the reconstituted formulations, posing risks to their effectiveness.
The suspension applies to all locally produced and imported versions of the Multi-Dose Artemether/Lumefantrine dry powder for oral use. NAFDAC has confirmed it will no longer process new applications, renewals, or variations for this product. Stability studies cited in the alert demonstrated that, once mixed with water, the oral suspension loses its potency over time, potentially rendering it ineffective against malaria.
This loss of efficacy could have serious consequences, the agency warned. “The instability may lead to worsening health conditions, increased risks of complications, treatment delays, or even death,” the alert stated. Malaria remains a major public health challenge, and ensuring the reliability of treatments is a top priority for NAFDAC.
To enforce the decision, NAFDAC has instructed its zonal directors and state coordinators across the country to conduct surveillance operations and remove all affected products from circulation. The agency has also issued a stern directive to importers, distributors, retailers, healthcare professionals, and caregivers to immediately stop importing, distributing, or selling the product.
Healthcare providers and the public have been urged to remain vigilant. NAFDAC is calling on professionals and consumers alike to report any suspected sales of the discontinued suspension, as well as any substandard or counterfeit medicines, to their nearest NAFDAC office. Reports of adverse events or side effects can also be submitted via the agency’s E-reporting platforms or the Med-safety app, available for download on Android and iOS devices.
This decisive action underscores NAFDAC’s commitment to protecting public health by ensuring that only safe and effective medicines remain available. The agency has promised to keep the public informed as the situation develops, with the full alert soon to be uploaded to its website for wider access.
For now, the message is clear: the Multi-Dose Artemether/Lumefantrine oral suspension is off the table, and NAFDAC is taking no chances with the nation’s wellbeing.
