NAFDAC withdraws approval of major anti-malaria drug

NAFDAC withdraws approval of major anti-malaria drug

The National Agency for Food and Drug Administration and Control (NAFDAC) has officially stopped the registration of Artemether/Lumefantrine dry powder for oral suspension, a widely used multi-dose anti-malarial medication.

The agency announced this decision through Public Alert No. 01/2025, posted on its website Thursday, citing concerns about the product’s stability after reconstitution, which may compromise its effectiveness.

According to the alert, “stability studies have shown that once reconstituted, the Artemether/Lumefantrine oral suspension becomes unstable, which can result in a loss of efficacy.”

This suspension covers both locally manufactured and imported versions of the product. NAFDAC stated it would no longer process new registrations, renewals, or variation applications for the drug.

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The agency warned that the instability of the suspension could lead to severe health consequences, including “worsening health conditions, increased risks of complications, treatment delays, or even death.”

In response, NAFDAC has instructed its zonal directors and state coordinators to conduct surveillance operations and remove the affected products from circulation.

The agency urged healthcare professionals, distributors, and retailers to halt the importation, sale, and distribution of the product immediately. Consumers and medical practitioners have also been encouraged to report any sightings of the drug or instances of substandard or counterfeit medicines to the nearest NAFDAC office.

Reports of adverse reactions or side effects can also be submitted via NAFDAC’s E-reporting platforms or through the Med-safety app, available on both Android and iOS devices.
NAFDAC confirmed that this alert would be shared with the World Health Organisation’s Global Surveillance and Monitoring System (GSMS).

NAFDAC withdraws approval of major anti-malaria drug