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NAFDAC Reaffirms Ban on Multi-Dose Artemether/Lumefantrine Oral Suspension Over Efficacy Concerns

NAFDAC reiterates its directive discontinuing the registration of multi-dose Artemether/Lumefantrine dry powder for oral suspension due to instability and loss of efficacy. The National Agency for Food and Drug Administration and Control (NAFDAC) has issued Public Alert No. 09/2026, reminding Nigerians of its earlier regulatory directive discontinuing the registration of all multi-dose Artemether/Lumefantrine dry powder formulations for oral suspension. The agency said the decision, first communicated in Public Alert No. 01/2025 published on February 27, 2025, remains fully in effect. According to NAFDAC, stability studies revealed that once reconstituted with water, multi-dose Artemether/Lumefantrine suspensions become unstable over time. This instability leads to a loss of efficacy, meaning the medicine may no longer effectively treat malaria. Health experts warn that reduced efficacy in anti-malarial drugs can have serious consequences. When a medication fails to work as intend...