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. The decision, which affects both locally manufactured and imported versions of the product, was made due to concerns over the instability of the medication in its reconstituted form, which compromises its effectiveness over time.
In a public statement released on its website on Monday, NAFDAC emphasized that it would no longer process new applications, renewals, or variations for Multi-Dose Artemether/Lumefantrine dry powder for oral suspension. The agency has also halted the legal circulation of the product in Nigeria, citing significant health risks associated with its use.
Instability and Health Risks
NAFDAC explained that 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 serious health risks, including the worsening of malaria symptoms, increased complications, treatment delays, and, in severe cases, potentially fatal outcomes.
“When a medication loses its effectiveness, it can jeopardise patient safety and public health,” the agency warned. The ban applies to all Multi-Dose Artemether/Lumefantrine dry powder brands for oral suspension, encompassing products from all manufacturers and importers.
Surveillance and Enforcement
To ensure compliance with the ban, NAFDAC has instructed its zonal directors and state coordinators to conduct surveillance operations nationwide to remove these products from circulation. The agency has also urged importers, distributors, retailers, healthcare professionals, and caregivers to immediately cease importing, distributing, selling, and using the affected products.
“The public is also encouraged to report any sightings of these items or incidents involving substandard or falsified medicines to the nearest NAFDAC office,” the statement added.
Reporting Adverse Events
NAFDAC has advised healthcare providers and consumers to report any adverse events or side effects linked to medicinal products through its e-reporting platforms, which are available on the agency’s website. This initiative aims to enhance monitoring and ensure timely intervention in cases of substandard or harmful medications.
International Awareness and Compliance
The agency noted that the ban will be communicated to the World Health Organisation’s (WHO) Global Surveillance and Monitoring System to ensure international awareness and compliance. This step underscores NAFDAC’s commitment to global health standards and its proactive approach to safeguarding public health.
Commitment to Public Safety
NAFDAC reaffirmed its commitment to public safety, stating, “NAFDAC remains customer-focused and agency-minded, prioritizing the health and well-being of Nigerians.” The agency’s decision to ban the Multi-Dose Artemether/Lumefantrine dry powder for oral suspension reflects its dedication to ensuring that only safe and effective medications are available to the public.
Implications for Malaria Treatment
Artemether/Lumefantrine is a widely used anti-malarial medication, particularly in regions where malaria is endemic. The ban on the multi-dose dry powder formulation highlights the importance of ensuring the stability and efficacy of medications used to treat life-threatening diseases like malaria.
Healthcare providers are advised to explore alternative formulations of Artemether/Lumefantrine or other approved anti-malarial medications to ensure effective treatment for patients. NAFDAC’s decision underscores the need for rigorous quality control and continuous monitoring of pharmaceutical products to protect public health.
Conclusion
NAFDAC’s ban on Multi-Dose Artemether/Lumefantrine dry powder for oral suspension is a significant step toward safeguarding public health in Nigeria. By addressing the instability and health risks associated with the product, the agency has demonstrated its commitment to ensuring the safety and efficacy of medications available to Nigerians.
The ban also highlights the importance of collaboration between regulatory agencies, healthcare providers, and the public in identifying and addressing substandard or harmful medications. As NAFDAC continues its surveillance and enforcement efforts, it remains focused on its mission to protect the health and well-being of all Nigerians.
The public is encouraged to remain vigilant and report any concerns about medicinal products to NAFDAC, ensuring that the agency can take swift action to address potential risks and uphold the highest standards of public health.
