The National Agency for Food and Drug Administration and Control has announced the immediate ban on the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension.
In a public statement released on its website on Monday, NAFDAC cited the instability in its reconstituted form that compromised its effectiveness over time for the ban.
It stated that the decision affects both locally manufactured and imported versions of the product.
The agency emphasised that it would no longer process new applications, renewals, or variations for Multi-Dose Artemether/Lumefantrine dry powder for oral suspension, halting its legal circulation in Nigeria.
According to NAFDAC, stability studies have shown that the reconstituted oral suspension of Artemether/Lumefantrine becomes unstable after mixing, leading to a gradual loss of efficacy.
“This degradation poses significant health risks, including the worsening of malaria symptoms, increased complications, treatment delays, and, in severe cases, potentially fatal outcomes. When a medication loses its effectiveness, it can jeopardise patient safety and public health,” the agency warned.
It added, “The ban applies to all Multi-Dose Artemether/Lumefantrine dry powder brands for oral suspension, encompassing products from all manufacturers and importers.”
NAFDAC has instructed its zonal directors and state coordinators to conduct surveillance operations nationwide to remove these products from circulation.
The agency also urged importers, distributors, retailers, healthcare professionals, and caregivers to immediately cease importing, distributing, selling, and using the affected products to prevent further risks associated with the use of these unstable formulations.
The statement added, “The public is also encouraged to report any sightings of these items or incidents involving substandard or falsified medicines to the nearest NAFDAC office.
“Additionally, healthcare providers and consumers are advised to report adverse events or side effects linked to medicinal products through NAFDAC’s e-reporting platforms, available on the agency’s website.”
NAFDAC noted that this ban will be communicated to the World Health Organisation’s Global Surveillance and Monitoring System to ensure international awareness and compliance.
The agency reaffirmed its commitment to public safety, stating, “NAFDAC remains customer-focused and agency-minded, prioritizing the health and well-being of Nigerians.”
