The National Agency for Food and Drug Administration and Control (NAFDAC) has announced an immediate ban on the registration and use of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension.
The announcement, made in a public statement issued by the NAFDAC’s Director-General Mojisola Adeyeye on Monday, sent shockwaves through Nigeria’s pharmaceutical and healthcare sectors, as the banned medication has been a widely used treatment for malaria; a disease that remains one of the country’s deadliest health challenges.
At the heart of NAFDAC’s decision is a disturbing discovery: the drug becomes unstable after being mixed, gradually losing its effectiveness. This degradation, the agency warned, poses serious health risks, from worsening malaria symptoms and delayed treatment to life-threatening complications.
“When a medication loses its effectiveness, it can jeopardize patient safety and public health,” the agency stated.
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The ban applies to all brands and versions of the drug, whether locally manufactured or imported. Effective immediately, NAFDAC will no longer process new applications, renewals, or variations for this product, halting its legal circulation in Nigeria.
To enforce the ban, NAFDAC has instructed its zonal directors and state coordinators to launch a nationwide surveillance operation aimed at removing the drug from shelves and distribution channels.
The agency also issued a stern warning to importers, distributors, retailers, and healthcare professionals to immediately stop the importation, sale, and use of the affected product, urging swift compliance to prevent further risks.
“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.
Healthcare providers and consumers were advised to report any adverse effects linked to the drug through NAFDAC’s e-reporting platforms, accessible on the agency’s website.
Taking the matter beyond Nigeria’s borders, NAFDAC announced plans to notify the World Health Organization’s Global Surveillance and Monitoring System about the ban. This step, the agency said, ensures international awareness and compliance, preventing the distribution of these compromised medications in other regions.
Source: Ripples
