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 intended:

The patient’s condition may worsen

Complications may arise

Treatment could be delayed

In severe cases, it may result in death

NAFDAC emphasized that ensuring drug stability is critical, especially for malaria treatment in children and vulnerable populations.

The directive applies to:

All brands of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension

All local manufacturers and importers

Both locally manufactured and imported products

The agency confirmed it no longer accepts:

New applications

Renewal applications

Variation applications

for multi-dose Artemether/Lumefantrine dry powder oral suspension products.

Manufacturers are now required to produce alternative, more stable formulations, including:

Dispersible tablets

Powder or granules packed in sachets for single-dose administration

These alternatives are considered safer and more stable, reducing the risk of reduced potency after reconstitution.

NAFDAC is urging healthcare professionals, pharmacists, distributors, and consumers to remain vigilant. Anyone who suspects the continued sale of these discontinued products, or encounters substandard or falsified medicines, is advised to report immediately.

Reports can be made through:

The nearest NAFDAC office

Toll-free number: 0800-162-3322

Email: sf.alert@nafdac.gov.ng

The agency reaffirmed its commitment to safeguarding public health and ensuring that only safe, effective, and quality-assured medicines are available in Nigeria.