NAFDAC discontinues Artemether/Lumefantrine dry powder registration

NIGERIA—The National Agency for Food and Drug Administration and Control (NAFDAC) has officially discontinued the registration of Multi-Dose Antimalarial (Artemether/Lumefantrine) dry powder for oral suspension.

This decision was announced in Public Alert No. 01/2025, following findings that the drug’s reconstituted formulation is unstable, which could lead to a gradual loss of efficacy over time.

As a result, this suspension applies to both locally manufactured and imported Multi-Dose Artemether/Lumefantrine oral suspension.

The agency further clarified that it will no longer process new applications, renewals, or variations for the registration of this product.

The decision is based on stability studies that showed the drug’s active ingredients degrade once mixed with a solvent.

This instability can compromise the medication’s effectiveness, potentially leading to treatment failure.

Given that malaria remains a significant health concern in Nigeria, ineffective treatment could result in worsening symptoms, increased complications, prolonged illness, or even fatalities.

NAFDAC has instructed all zonal directors and state coordinators to conduct thorough surveillance operations to enforce this directive.

This will involve identifying and removing all affected products from circulation to prevent further use.

Additionally, the agency has urged importers, distributors, and retailers to immediately halt the importation, distribution, and sale of the product.

Healthcare professionals and caregivers have also been advised to discontinue prescribing or recommending this formulation.

 Furthermore, NAFDAC encourages them to report any ongoing sales or distribution of the affected products.

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