NAFDAC bans registration of multi-dose anti-malarial drugs
The National Agency for Food and Drug Administration and Control has declared an immediate prohibition on the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder intended for oral suspension.
In a public announcement published on its website on Monday, NAFDAC referenced the instability of the product in its reconstituted state, which undermines its effectiveness over time, as the reason for this ban.
The agency indicated that this decision applies to both domestically produced and imported variants of the medication.
NAFDAC stressed that it will cease to process any new applications, renewals, or modifications for Multi-Dose Artemether/Lumefantrine dry powder for oral suspension, effectively terminating its legal distribution within Nigeria.
According to NAFDAC, stability assessments have revealed that the reconstituted oral suspension of Artemether/Lumefantrine deteriorates after mixing, resulting in a gradual decline in efficacy.
“This degradation presents considerable health hazards, including the exacerbation of malaria symptoms, heightened complications, delays in treatment, and, in severe instances, potentially fatal consequences. The loss of medication effectiveness can endanger patient safety and public health,” the agency cautioned.
The statement indicated, “The prohibition encompasses all brands of Multi-Dose Artemether/Lumefantrine dry powder intended for oral suspension, including products from every manufacturer and importer.”
NAFDAC has directed its zonal directors and state coordinators to implement surveillance operations across the nation to eliminate these products from the market.
Furthermore, the agency has called upon importers, distributors, retailers, healthcare professionals, and caregivers to immediately halt the importation, distribution, sale, and use of the affected products to mitigate further risks associated with these unstable formulations.
The statement continued, “The public is encouraged to report any instances of these products or occurrences involving substandard or counterfeit medicines to the nearest NAFDAC office.”
“Moreover, healthcare providers and consumers are urged to report any adverse events or side effects related to medicinal products through NAFDAC’s e-reporting platforms, which are accessible on the agency’s website.”
NAFDAC emphasized that this ban will be communicated to the World Health Organization’s Global Surveillance and Monitoring System to ensure global awareness and adherence.
The agency reiterated its dedication to public safety, asserting, “NAFDAC remains focused on customer needs and agency responsibilities, prioritizing the health and well-being of Nigerians.”
