The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the discontinuation of the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension.
The decision follows stability concerns, as studies have shown that the reconstituted formulations lose efficacy over time.
The announcement was made in a public alert No. 01/2025, released on the agency’s website on Thursday.
NAFDAC confirmed that the suspension applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral use.
Consequently, the agency will no longer accept new applications, renewals, or variations for any local or imported Multi-Dose Artemether/Lumefantrine dry powder for oral suspension.
According to NAFDAC, stability studies revealed that reconstituted Artemether/Lumefantrine oral suspension becomes unstable after mixing, leading to a loss of efficacy.
“This loss can have severe health consequences, including treatment failure, increased risk of complications, and, in extreme cases, death,” the agency stated.
Directive for market withdrawal
All NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance and remove all affected products from circulation.
- The agency has also directed importers, distributors, retailers, healthcare professionals, and caregivers to immediately halt the importation, distribution, sale, and use of these medications.
- NAFDAC has urged healthcare professionals and consumers to report any suspected sale of these products or related substandard medicines to the nearest NAFDAC office or via the agency’s toll-free number: 0800-162-3322. Reports can also be submitted via email at [email protected].
- Additionally, individuals are encouraged to report adverse reactions through the Med-Safety mobile app, available on Android and iOS, or via email at [email protected].
NAFDAC confirmed that this notification would be uploaded to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS) as part of its regulatory measures.
NAFDAC’s commitment to public health
The agency reaffirmed its commitment to safeguarding public health and ensuring the availability of safe and effective medicines in Nigeria.
NAFDAC’s Strategic Plan for 2025
As NAFDAC reflects on the progress made over the past seven years, it becomes evident that significant strides have been achieved in strengthening Nigeria’s regulatory framework. However, there is still much more to accomplish.
- This realization has reinforced the agency’s commitment to strategically enhancing the regulatory system to ensure public health and safety.
- Looking ahead to 2025, the focus remains on fortifying regulatory structures while unlocking opportunities within the pharmaceutical and food industries.
- A key priority will be improving access to high-quality, well-regulated products by strengthening industry compliance, fostering innovation, and enhancing oversight mechanisms.
By reinforcing the value chain and ensuring stringent regulatory enforcement, NAFDAC aims to build a more robust healthcare and consumer safety ecosystem, one that guarantees the availability of safe and effective products for Nigerians.
