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Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has announced that it has discontinued the registration of multi-dose artemether/lumefantrine dry powder for oral suspension.

This comes after stability studies showed that artemether/lumefantrine oral suspension becomes unstable after reconstitution, leading to a loss in efficacy over time. 

Consequently, patients are exposed to increased morbidity, length of hospital stays, higher costs of treatment, antimicrobial resistance and sometimes death.

About Artemether Lumefantrine
Artemether is an antimalarial medication used in management of acute uncomplicated malaria. 

It is administered in combination with lumefantrine for improved efficacy.

This combination therapy exerts its effects against the erythrocytic stages of Plasmodium species and may be used to treat malaria caused by P. falciparum and unidentified Plasmodium species, including infections acquired in chloroquine-resistant areas.

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NAFDAC’s directive

Due to the observed efficacy concerns, NAFDAC has stated that it will no longer accept new, renewal, or variation applications for any brand of local or imported multi-dose artemether/lumefantrine dry powder for oral suspension, encouraging healthcare practitioners to explore alternative treatment options for pediatrics.

Conclusion

The Agency has therefore directed retailers, wholesalers, distributors and healthcare workers to cease importation, distribution, sale and use of this antimalarial formulation while encouraging consumers to report any adverse effects experienced from prior use of the medication.

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