Official Public Notice from NAFDAC
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an important update regarding the safety and regulatory status of Multi-Dose Artemether/Lumefantrine dry powder for oral suspension, a commonly used anti-malarial medication in Nigeria.
Following stability testing and product evaluations, NAFDAC has officially discontinued the registration and approval of all locally manufactured and imported multi-dose Artemether/Lumefantrine oral suspensions due to instability after reconstitution, which leads to reduced drug efficacy over time.
Scope of Discontinuation
This directive affects all brands and formulations of multi-dose Artemether/Lumefantrine dry powder for oral suspension, whether locally manufactured or imported.
Effective immediately, NAFDAC will no longer accept:
- New registration applications
- Renewal applications
- Variation applications
for any multi-dose Artemether/Lumefantrine dry powder oral suspension products.
Risk Statement
Scientific evaluations have demonstrated that once reconstituted, artemether/lumefantrine oral suspension becomes unstable over time, which may compromise the product’s efficacy. The use of such degraded medication can result in:
- Treatment failure
- Disease progression
- Delayed recovery
- Increased risk of complications
- In extreme cases, fatal outcomes
Affected Product Details
- Product Name: All brands of Multi-Dose Artemether/Lumefantrine Dry Powder for Oral Suspension
- Manufacturers/Importers: All local and international manufacturers and importers of the aforementioned product type
Enforcement Actions
All NAFDAC Zonal Directors and State Coordinators have been instructed to initiate immediate surveillance and market withdrawal of all affected products across their respective jurisdictions.
Advisory to Stakeholders
NAFDAC advises all importers, distributors, retailers, healthcare professionals, and caregivers to:
- Cease importation, distribution, sale, and use of all affected products immediately
In addition, reports of adverse drug reactions or side effects may be submitted via:
- The nearest NAFDAC office
- The e-reporting portal on the NAFDAC website: www.nafdac.gov.ng
- The Med-Safety App (available on Android and iOS)
- Email: pharmacovigilance@nafdac.gov.ng
International Notification
This directive will also be communicated to the WHO Global Surveillance and Monitoring System (GSMS) for global public health awareness.