The National Agency for Food and Drug Administration and Control (NAFDAC) has disclosed the stoppage of its registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension.
The agency, in a public alert No. 01/2025 posted on its website stated that the regulatory step was taken due to the instability of the reconstituted formulations, which can lead to a loss of efficacy over time.
While stating that the suspension of the drug applies to all locally manufactured and imported ones, the NAFDAC maintained that it would no longer accept new applications, renewals, or variations for this product.
It pointed out that stability studies had shown that once reconstituted, the Artemether/Lumefantrine oral suspension becomes unstable, which can result in a loss of efficacy, and could lead to worsening health conditions, increased risks of complications, treatment delays, or even death.
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The NAFDAC directed all zonal directors and state coordinators to carry out surveillance activities and remove all locally manufactured and imported products from circulation even as it advised importers, distributors, retailers, healthcare professionals, and caregivers to cease the importation, distribution, and sale of the product immediately.
The agency stated that healthcare professionals and consumers had been directed to report any suspected sale of these products, and any substandard or falsified medicines, to its nearest office nationwide.
Similarly, the alert reflected that members of the public could also report adverse events or side effects through the agency’s E-reporting platforms or via the Med-safety application available on Android and iOS.
The NAFDAC stated that the published alert would be uploaded to the World Health Organisation’s (WHO’s) Global Surveillance and Monitoring System (GSMS) to keep the global community informed about its latest regulatory stance on the products.
