The National Agency for Food and Drug Administration and Control (NAFDAC) has announced an immediate ban on the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension.
In a statement released on Monday, the agency cited stability issues in its reconstituted form, which compromise its effectiveness over time. This decision affects both locally manufactured and imported versions of the product.
NAFDAC emphasized that it would no longer process new applications, renewals, or variations for the medication, effectively halting its legal circulation in Nigeria.
According to the agency, stability studies indicate that once reconstituted, the suspension becomes unstable, leading to a gradual loss of efficacy. This degradation, NAFDAC warned, poses serious health risks, including worsening malaria symptoms, treatment delays, and potential fatal outcomes.
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The ban applies to all brands of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension, regardless of manufacturer or importer.
NAFDAC has directed its zonal directors and state coordinators to conduct nationwide surveillance operations to remove the affected products from circulation. Importers, distributors, retailers, healthcare professionals, and caregivers have been urged to stop all importation, distribution, sale, and use of the product to prevent further risks.
The agency also encouraged the public to report sightings of the banned product or any incidents of substandard or falsified medicines to the nearest NAFDAC office. Additionally, healthcare providers and consumers have been advised to report any adverse reactions or side effects linked to medicinal products via NAFDAC's e-reporting platforms.
NAFDAC stated that this ban would be communicated to the World Health Organization's Global Surveillance and Monitoring System to ensure international awareness and compliance.
Reaffirming its commitment to public safety, the agency assured Nigerians that it remains focused on safeguarding health and well-being across the country.
