The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the discontinuation of the registration of multi-dose antimalarial Artemether/Lumefantrine dry powder for oral suspension, citing concerns over the instability of the reconstituted formulation, which compromises its efficacy and safety over time.
In a statement released via its official X account (@NafdacAgency), the agency confirmed that the suspension applies to all brands of locally manufactured and imported multi-dose Artemether/Lumefantrine dry powder for oral use. As a result, NAFDAC will no longer process new applications, renewals, or variation requests for these products.
Explaining the rationale behind the decision, the agency stated that stability studies have shown that the formulation becomes unstable after reconstitution, reducing its effectiveness in treating malaria. This loss of efficacy, NAFDAC warned, poses serious safety risks, including prolonged illness, complications, treatment failure, and in severe cases, fatalities.
To enforce compliance, all NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance operations and retrieve affected products from circulation. Importers, distributors, retailers, healthcare professionals, and caregivers have been urged to immediately cease the importation, distribution, sale, and use of the banned products.
NAFDAC also called on healthcare providers and the public to report any suspected sale of the affected products or any instances of substandard or falsified medicines to the nearest NAFDAC office. Additionally, it encouraged reporting of adverse drug reactions through its E-reporting platforms, available on the agency’s official website.
Meanwhile, the Lagos State Government has launched the Pathway to Malaria Pre-Elimination & Digitisation Programme, a new initiative aimed at accelerating malaria eradication through digital innovations, improved case management, and strengthened public-private partnerships.
Speaking at a press briefing at the Lagos State Ministry of Health, the Commissioner for Health, Prof. Akin Abayomi, described the initiative as a significant step toward reducing malaria prevalence in Lagos to below one per cent. He noted that despite Lagos having a lower malaria burden compared to the national average, the state still records an estimated 900,000 cases annually.
Abayomi highlighted malaria as a major social and economic challenge, contributing to absenteeism from work and school, decreased productivity, and rising healthcare costs. He explained that the new initiative will integrate digital health solutions, including a real-time electronic malaria reporting system developed in collaboration with Maisha Meds, to improve malaria surveillance and data collection across public and private health facilities.
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