The National Agency for Food and Drug Administration and Control (NAFDAC) has announced an immediate ban on the registration, renewal, and variation of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension in Nigeria.
In a statement issued on its website on Monday, March 3, NAFDAC cited concerns over the product’s instability after reconstitution, which compromises its effectiveness over time.
The agency noted that this ban applies to both locally manufactured and imported versions of the drug.
NAFDAC explained that stability studies had revealed that the reconstituted form of Artemether/Lumefantrine becomes unstable, leading to a gradual loss of its therapeutic efficacy.
This degradation, the agency warned, could have severe health implications, including the exacerbation of malaria symptoms, increased complications, treatment delays, and in extreme cases, potentially fatal outcomes.
“The loss of effectiveness in the reconstituted oral suspension poses significant health risks, jeopardising patient safety and public health,” NAFDAC stated, underscoring the importance of effective malaria treatment in the country.
The ban will halt the legal circulation of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension in Nigeria.
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NAFDAC has directed its zonal directors and state coordinators to conduct surveillance operations nationwide to ensure the affected products are removed from circulation.
Importers, distributors, retailers, healthcare professionals, and caregivers have been instructed to immediately cease the import, distribution, sale, and use of these unstable formulations.
NAFDAC also urged the public to report any sightings of the affected products, as well as any incidents involving substandard or falsified medicines, to the nearest NAFDAC office.
The agency also provided details on how healthcare providers and consumers can report adverse events or side effects related to medicines through NAFDAC’s e-reporting platforms available on its website.
NAFDAC confirmed that the ban would be communicated to the World Health Organization’s (WHO) Global Surveillance and Monitoring System to ensure international awareness and compliance with the decision.
The agency reiterated its commitment to safeguarding public health, stating, “NAFDAC remains customer-focused and agency-minded, prioritising the health and well-being of Nigerians.”
This move is part of NAFDAC’s ongoing efforts to ensure that only safe and effective medicines are available in the Nigerian market, reinforcing its role in the protection of public health.
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