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.
According to the alert, the decision was made due to the instability of the reconstituted formulations, which can lead to a loss of efficacy over time.
It said the suspension applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral use.
NAFDAC will no longer accept new applications, renewals, or variations for this product.
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.
The agency said this could lead to worsening health conditions, increased risks of complications, treatment delays, or even death.
It said NAFDAC had directed all zonal directors and state coordinators to carry out surveillance activities and remove all locally manufactured and imported products from circulation.
It said healthcare professionals and consumers had been urged to report any suspected sale of these products, as well as any substandard or falsified medicines, to the nearest NAFDAC office.
The agency said the public could also report adverse events or side effects through the agency’s E-reporting platforms or via the Med-safety application available on Android and iOS.
Posts
No comments:
Post a Comment