Victor EzejaThe National Agency for Food and Drug Administration and Control (NAFDAC) has banned the use of multi-dose antimalarial (Artemether/Lumefantrine) dry powder for oral solution.
The agency said its decision was based on a recent troubling discovery that mixing the medicine causes it to become unstable, and gradually loses its potency.
Join our WhatsApp ChannelThe agency cautioned that there are major health hazards associated with this degradation, ranging from life-threatening consequences to worsened malaria symptoms and delayed treatment.
This was made known in a Public Alert issued by NAFDAC on Thursday.
The statement said that following the discovery, NAFDAC would henceforth stop further registration of other brands of such combination, renewals, or variations for the product.
The agency’s decision comes as a big shock to Nigeria’s pharmaceutical and healthcare sectors, as the banned medication had been a widely used treatment for malaria, which remains one of the country’s top health challenges.
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While stating that the ban takes immediate effect, NAFDAC clarified that it applies to all brands and versions of the drug both produced locally or imported.
Highlighting the reason for the ban, the agency said: “Stability studies have demonstrated that reconstituted artemether/lumefantrine oral suspension becomes unstable after mixing, resulting in a loss of efficacy over time.
“When a medication loses its effectiveness, it can lead to various health issues, such as the worsening of the condition being treated, an increased risk of complications, delays in treatment, and in severe cases, it may even result in death.”
To get the medicine off store shelves and distribution channels, NAFDAC has directed its zonal directors and state coordinators to begin a nationwide monitoring operation.
In order to avoid additional hazards, the agency also strongly advised importers, distributors, retailers, and medical professionals to immediately cease the importation, sale, and use of the impacted product.
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“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 NAFDAC stated.
It also advised healthcare providers and consumers to report any adverse effects linked to the drug through NAFDAC’s e-reporting platforms, accessible on the agency’s website.
NAFDAC further declared that it would communicate the prohibition to the Global Surveillance and Monitoring System of the World Health Organisation. According to the agency, this action guarantees global knowledge and adherence, stopping the spread of these compromised drugs in other parts of the world.
Victor Ezeja is a passionate journalist with six years of experience writing on economy, politics and energy. He holds a Masters degree in Mass Communication.
