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 compromises its effectiveness over time for the ban, saying 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 jeopardize 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.”
