National Agency for Food and Drug Administration and Control (NAFDAC) has renewed a public warning over the discontinued registration of certain multi-dose anti-malarial medicines, citing concerns about reduced effectiveness after preparation.
In a statement on Friday reminded healthcare providers and the public that it no longer approves the registration of multi-dose artemether/lumefantrine dry powder for oral suspension.
The directive, first issued in 2025, applies to all locally manufactured and imported multi-dose formulations of artemether/lumefantrine dry powder intended to be mixed with water before use.
NAFDAC said stability studies had shown that once reconstituted, the anti-malarial suspensions can become unstable, leading to a loss of efficacy.
Artemether/lumefantrine is a widely used combination therapy for the treatment of uncomplicated malaria. However, the regulator said that if the prepared suspension loses potency, patients may receive sub-therapeutic doses.
“When a medication loses its efficacy, it becomes less effective, which can have serious health consequences,” the agency warned. These may include worsening illness, a higher risk of complications, delays in recovery and, in severe cases, death.
The agency said it no longer accepts new applications, renewals or variations for the affected multi-dose dry powder formulations.
Manufacturers have instead been directed to produce alternative formulations, such as dispersible tablets or single-dose powders or granules packaged in sachets, which are considered more stable.
The alert covers all brands and all manufacturers and importers of multi-dose artemether/lumefantrine dry powder for oral suspension.
Healthcare professionals and consumers have been urged to report any suspected sale of the discontinued products, as well as any substandard or falsified medicines, to the nearest NAFDAC office.
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