NAFDAC Suspends Registration of Artemether/Lumefantrine Oral Suspension

The National Agency for Food and Drug Administration and Control (NAFDAC) has suspended the registration of Artemether/Lumefantrine dry powder for oral suspension due to concerns about its stability and effectiveness after being mixed with liquid.

According to NAFDAC, this decision applies to both locally produced and imported multi-dose formulations of the medication. Stability tests have shown that once reconstituted, the drug gradually loses its potency, which could lead to ineffective malaria treatment.

“This instability increases the risk of treatment failure, complications, and, in severe cases, life-threatening consequences,” the agency cautioned.

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As a precautionary measure, NAFDAC has ceased accepting new applications, renewals, and modifications related to this product to protect public health.

The agency has directed its zonal directors and state coordinators to ensure that affected products are withdrawn from circulation. Additionally, all importers, distributors, retailers, and healthcare providers have been ordered to immediately stop importing, distributing, selling, or administering the medication.

NAFDAC has urged healthcare professionals and the public to report any ongoing sale or distribution of the affected drug to the nearest NAFDAC office or through the agency’s toll-free hotline (0800-162-3322). Reports can also be sent via email at sf.alert@nafdac.gov.ng, while adverse drug reactions can be recorded using the Med-Safety mobile app or emailed to pharmacovigilance@nafdac.gov.ng.

As part of international regulatory efforts, NAFDAC has submitted this advisory to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS).

The agency reassured Nigerians of its commitment to ensuring that only safe and effective medicines remain available in the country.

To strengthen pharmaceutical oversight, NAFDAC plans to enhance industry compliance, tighten regulatory enforcement, and prevent the distribution of substandard medications.

By maintaining rigorous quality control measures, the agency aims to protect public health and ensure Nigerians have reliable access to safe and effective treatments.