The National Agency for Food and Drug Administration and Control (NAFDAC) would like to inform the public that it has discontinued the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension. This decision was made due to the instability of the reconstituted formulations, which can lead to a loss of efficacy over time.
This suspension applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral use. Please note that NAFDAC will no longer accept new applications, renewal applications, or variation applications for any local or imported Multi-Dose Artemether/Lumefantrine dry powder for oral suspension.
Risk Statement
Stability studies have demonstrated that reconstituted artemether/lumefantrine oral suspension becomes unstable after mixing, resulting in a loss of efficacy over time. When a medication loses its effectiveness, it can lead to various health issues, such as the worsening of the condition being treated, an increased risk of complications, delays in treatment, and severe cases, it may even result in death.
Product details
The details of the product are as follows.
Product Brand Name: All brands of Multi-Dose Artemether/ Lumefantrine dry powder oral Suspension.
Product Manufacturer: All manufacturers and Importers of Multi-Dose Anti-Malarial (Artemether/ Lumefantrine dry powder Oral Suspension.
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance activities and mop up all locally manufactured and imported Multi-Dose Artemether/ Lumefantrine dry powder for Oral Suspension products within the zones and states.
Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to immediately stop the importation, distribution, sale, and use of all Multi-Dose Artemether/ Lumefantrine dry powder Oral Suspension products.
Healthcare professionals and consumers are advised to report any suspicion of sale of these products, substandard and falsified medicines, or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
