Nigeria’s drug regulatory agency, the National Agency for Food and Drug Administration and Control (NAFDAC), issued a public alert yesterday discontinuing the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension, citing instability issues that could compromise patient safety.
“Stability studies have shown that once reconstituted, the Artemether/Lumefantrine oral suspension becomes unstable, which can result in a loss of efficacy,” NAFDAC stated in Public Alert No. 01/2025 published on its website Thursday.
The ban applies to both locally manufactured and imported versions of the product. The agency will no longer accept new applications, renewals, or variations for this formulation.
NAFDAC warned that the use of these unstable formulations could lead to serious health consequences, including “worsening health conditions, increased risks of complications, treatment delays, or even death.”
The regulatory body has directed all zonal directors and state coordinators to conduct surveillance activities to remove the affected products from circulation. Importers, distributors, retailers, healthcare professionals, and caregivers have been instructed to immediately cease importing, distributing, and selling these products.
Healthcare professionals and consumers are encouraged to report any suspected sale of these products or any adverse events through the agency’s e-reporting platforms or via the Med-Safety application available on Android and iOS devices.
The alert will also be uploaded to the World Health Organisation’s (WHO) Global Surveillance and Monitoring System, ensuring international awareness of the safety concern.
Malaria remains a significant public health challenge in Nigeria, with millions of cases reported annually.
Follow the AkweyaTV channel on WhatsApp: https://whatsapp.com/channel/0029Va7m7dvJuyA7h5XMc22i
