NAFDAC bans multi-dose anti-malarial drug over safety concerns

The National Agency for Food and Drug Administration and Control (NAFDAC) has imposed an immediate ban on the registration, sale, and use of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension.

 The decision, announced in a public statement by NAFDAC’s Director-General, Prof. Mojisola Adeyeye, on Monday, has triggered significant reactions across Nigeria’s pharmaceutical and healthcare sectors, as the medication has been a common treatment for malaria—one of the country’s leading causes of death.

NAFDAC’s decision follows findings that the medication becomes unstable after being reconstituted, leading to a gradual loss of effectiveness.

The agency raised alarms about the risks associated with using a drug that degrades over time, stating that it could result in treatment failures, prolonged malaria symptoms, and severe health complications.

“When a medication loses its potency after preparation, it poses a direct threat to patient safety and public health,” NAFDAC stated.

The regulatory action applies to all brands and formulations of the affected medication, whether locally manufactured or imported. NAFDAC confirmed that it would no longer process new applications, renewals, or modifications for the product, effectively removing it from Nigeria’s pharmaceutical market.

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To enforce the ban, the agency has deployed its zonal directors and state coordinators to conduct a nationwide surveillance and recall operation, ensuring that the drug is removed from shelves and supply chains immediately.

Importers, distributors, retailers, and healthcare providers have been instructed to cease all transactions involving the banned drug. The agency warned of stringent legal actions against any individual or company found violating the directive.

“The public is urged to report any continued sales or distribution of this product to NAFDAC offices nationwide,” the statement read.

Additionally, consumers and healthcare professionals have been advised to report any adverse reactions or treatment failures related to the drug through NAFDAC’s e-reporting platforms available on its official website.

In a bid to prevent the circulation of the affected medication beyond Nigeria’s borders, NAFDAC disclosed that it would alert the World Health Organization (WHO) through its Global Surveillance and Monitoring System.

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This international notice is expected to enhance global awareness and compliance with the ban, ensuring that substandard versions of the drug do not enter other markets.

The sudden ban raises concerns about alternative malaria treatment options, particularly in a country where the disease is endemic. However, NAFDAC assured the public that safer, single-dose anti-malarial alternatives remain available and urged healthcare providers to transition patients to approved treatments.

This decisive action underscores NAFDAC’s commitment to safeguarding public health and ensuring that only safe, effective medications remain in circulation in Nigeria’s pharmaceutical landscape.