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Saturday, April 5, 2025

NAFDAC Stops Registration of Anti-Malarial Drug Over Stability Concerns

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The National Agency for Food and Drug Administration and Control (NAFDAC) has discontinued the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension due to stability issues.

In a public alert released on Thursday, NAFDAC stated that the decision was made after stability studies showed that the reconstituted formulations of the drug become unstable, leading to a loss of efficacy over time.

“This can result in worsening health conditions, increased risks of complications, treatment delays, or even death,” the agency warned.

NAFDAC has directed its zonal directors and state coordinators to remove all locally manufactured and imported products from circulation. The agency has also advised importers, distributors, retailers, healthcare professionals, and caregivers to cease the importation, distribution, and sale of the product immediately.

The agency urged healthcare professionals and consumers to report any suspected sale of these products, as well as any substandard or falsified medicines, to the nearest NAFDAC office.

NAFDAC also encouraged the public to report adverse events or side effects through the agency’s E-reporting platforms or via the Med-safety application available on Android and iOS.

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