Ifunanya Okafor28 February 2025
The National Agency for Food and Drug Administration and Control (NAFDAC) has officially discontinued the registration of the multi-dose anti-malarial dry powder for oral suspension containing Artemether/Lumefantrine. The decision comes after stability studies revealed that the reconstituted formulation becomes unstable over time, leading to a significant loss of efficacy and posing serious risks to patients. The discontinuation affects all brands of the product, both locally manufactured and imported. NAFDAC has announced that it will no longer accept new registration applications, renewals, or variations for these products. Authorities have urged importers, distributors, retailers, healthcare professionals, and caregivers to immediately cease the importation, distribution, sale, and use of the affected formulations. Health experts warn that the instability of these products could lead to treatment failures, increased morbidity, and even contribute to the development of antimalarial drug resistance. The potential consequences of such treatment failures include prolonged hospital stays, higher treatment costs, and, in severe cases, an increased risk of mortality. This decisive move by NAFDAC reinforces its commitment to ensuring that only safe, high-quality, and effective medications are available to the Nigerian public. The agency has also called on healthcare professionals and consumers to report any instances of sale or adverse reactions associated with these products to help prevent further health risks. By taking this proactive step, NAFDAC aims to protect public health and uphold stringent pharmaceutical standards across the nation.