The National Agency for Food and Drug Administration and Control (NAFDAC) has directed the immediate withdrawal of all multi-dose Artemether/Lumefantrine dry powder for oral suspension still in circulation across Nigeria.
The agency reiterated that the multi-dose malaria oral suspension is no longer approved for registration, importation, or use in the country. The directive was restated in a public notice on its website and had earlier been announced in Public Alert No. 01/2025 issued on February 27, 2025.
The move follows surveillance reports indicating that the affected products are still being dispensed to patients despite the regulatory restriction.
Switch to Safer Alternatives
NAFDAC directed all manufacturers and importers of multi-dose Artemether/Lumefantrine dry powder for oral suspension to switch production to dispersible tablets or single-dose sachets.
The regulatory directive applies to both locally manufactured and imported products, as the agency no longer accepts new, renewal, or variation applications for the multi-dose oral suspension form.
According to the agency, stability studies have shown that reconstituted anti-malarial suspensions are unstable, leading to reduced efficacy.
“Stability studies have demonstrated that reconstituted anti-malarial suspensions are unstable, resulting in a loss of efficacy. When a medication loses its efficacy, it becomes less effective, which can have serious health consequences.
“This may lead to a worsening of the treated condition, an increased risk of complications, delays in treatment, and, in severe cases, could even result in death,” the agency stated.
Affected Brands
The directive covers all brands of multi-dose Artemether/Lumefantrine dry powder for oral suspension, including:
Bellartem
Lokmal
HAVAX
PALUDEX
WINART
BIOLUMEFAR
FANETHA
Artemelum
Cikatem
Enforcement and Public Advisory
NAFDAC has instructed its zonal directors and state coordinators to intensify surveillance and remove all affected products from markets within their jurisdictions.
Consumers and healthcare professionals have been urged to report suspected sales of substandard or falsified anti-malarial products, or any adverse effects, to the nearest NAFDAC office. Reports can also be made through the Med-Safety mobile application, the e-reporting platforms on the agency’s website, or via its official pharmacovigilance email.
Importers, distributors, retailers, and healthcare professionals are advised to immediately cease the importation, distribution, sale, and use of all multi-dose anti-malarial oral suspension products.
The development underscores ongoing regulatory efforts to safeguard public health and ensure the effectiveness of anti-malarial treatments nationwide.
