Posted on: Tue 04-03-2025

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the discontinuation of the registration of multi-dose antimalarial Artemether/Lumefantrine dry powder for oral suspension, citing concerns over the instability of the reconstituted formulation, which can lead to a loss of efficacy over time.

In a statement released via its official account on X (@NafdacAgency), the agency clarified that the suspension applies to all brands of locally manufactured and imported multi-dose Artemether/Lumefantrine dry powder for oral use. NAFDAC further stated that it will no longer accept new applications, renewal applications, or variation requests for the affected products.

Explaining the rationale behind the decision, NAFDAC noted that stability studies have shown that the formulation becomes unstable after reconstitution, potentially reducing its effectiveness in treating malaria. The agency warned that the loss of efficacy could lead to serious health risks, including prolonged illness, increased complications, treatment delays, and, in severe cases, fatalities.

To enforce this directive, all NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance activities and retrieve all affected products from circulation. NAFDAC urged importers, distributors, retailers, healthcare professionals, and caregivers to immediately halt the importation, distribution, sale, and use of the discontinued products.

The agency also called on healthcare professionals and consumers to report any suspected sale of the affected products or substandard and falsified medicines to the nearest NAFDAC office. Additionally, it encouraged reporting of any adverse effects related to medicinal products through its E-reporting platforms, which are available on the NAFDAC website.

MEANWHILE, the Lagos State Government has announced the launch of the Pathway to Malaria Pre-Elimination &DigitisationProgramme, a new initiative aimed at accelerating the eradication of malaria through digital innovations, enhanced case management, and stronger public-private partnerships.

Speaking at a press briefing at the Lagos State Ministry of Health, the Commissioner for Health, Prof. Akin Abayomi, emphasised that the initiative is a significant step toward reducing malaria prevalence in Lagos to below one per cent. He noted that despite the state’s relatively low malaria burden compared to the national average, an estimated 900,000 malaria cases are still recorded yearly.

According to him, malaria remains a social and economic problem, contributing to absenteeism from work and school, decreased productivity, and high healthcare costs. He explained that the initiative would integrate digital health solutions, including a real-time electronic malaria reporting system developed in collaboration with Maisha Meds to improve malaria surveillance and data collection across public and private health facilities.

SOURCE: GUARDIAN NEWSPAPER

---

---