The National Agency for Food and Drug Administration and Control (NAFDAC) suspends the registration of Artemether/Lumefantrine dry powder for oral suspension due to concerns over its stability and effectiveness after reconstitution.
NAFDAC states that all locally manufactured and imported multi-dose Artemether/Lumefantrine dry powder for oral suspension are affected by this decision. Stability studies reveal that once reconstituted, the formulation loses its potency over time, which may compromise treatment effectiveness.
“This instability increases the risk of treatment failure, complications, and, in severe cases, life-threatening consequences,” the agency warns.
Following this finding, NAFDAC stops accepting new applications, renewals, and modifications for the product to safeguard public health.
The agency instructs its zonal directors and state coordinators to enforce the removal of affected products from circulation. Importers, distributors, retailers, and healthcare providers must immediately cease importation, distribution, sale, and use of the medication.
Healthcare professionals and consumers are urged to report any suspected sale of the affected drug or similar substandard medicines to the nearest NAFDAC office or through the agency’s toll-free line (0800-162-3322). Reports can also be sent via email at sf.alert@nafdac.gov.ng, or adverse reactions can be logged through the Med-Safety mobile app or via pharmacovigilance@nafdac.gov.ng.
NAFDAC confirms that this advisory is uploaded to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS) as part of international regulatory measures.
The agency reassures Nigerians that it remains committed to ensuring the safety, efficacy, and availability of quality medicines in the country.
NAFDAC outlines plans to enhance pharmaceutical oversight, improve industry compliance, and strengthen regulatory enforcement to prevent the circulation of ineffective medications.
By reinforcing safety standards and ensuring stringent quality control, the agency aims to build a stronger regulatory framework that protects public health and guarantees access to safe and effective medical products for Nigerians.
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