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.
This decision was made due to the instability of the reconstituted formulations, which compromises their effectiveness over time.
Stability studies have shown that the reconstituted oral suspension of Artemether/Lumefantrine becomes unstable after mixing, leading to a gradual loss of efficacy. This degradation poses significant health risks, including worsening malaria symptoms, increased complications, treatment delays, and potentially fatal outcomes.
The ban applies to all Multi-Dose Artemether/Lumefantrine dry powder brands for oral suspension, encompassing products from all manufacturers and importers. NAFDAC will no longer process new applications, renewals, or variations for these products.
The use of unstable anti-malarial drugs can have severe consequences on public health. Malaria is a significant public health concern in Nigeria, and the use of ineffective treatments can lead to increased morbidity and mortality.
NAFDAC’s decision to ban these products demonstrates the agency’s commitment to protecting public health and ensuring that only safe and effective medicines are available to consumers.
NAFDAC has instructed its zonal directors and state coordinators to conduct surveillance operations nationwide to remove these products from circulation. Importers, distributors, retailers, healthcare professionals, and caregivers are advised to immediately cease importing, distributing, selling, and using the affected products.
Healthcare providers and consumers are advised to report adverse events or side effects linked to medicinal products through NAFDAC’s e-reporting platforms or via email.
NAFDAC will communicate this ban to the World Health Organization’s Global Surveillance and Monitoring System to ensure international awareness and compliance.
This move demonstrates NAFDAC’s commitment to collaborating with international regulatory agencies to ensure the safety and efficacy of medicinal products.
The ban on Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension is a significant step towards protecting public health in Nigeria. NAFDAC’s decision demonstrates the agency’s commitment to ensuring that only safe and effective medicines are available to consumers.
As the agency continues to work towards safeguarding public health, it is essential for stakeholders, including healthcare professionals, consumers, and regulatory agencies, to collaborate and support NAFDAC’s efforts.
