NAFDAC Reinforces Prohibition on Multi-Dose Anti-Malaria Suspensions

The National Agency for Food and Drug Administration and Control (NAFDAC) has reaffirmed its regulatory order to halt the registration of multi-dose artemether/lumefantrine dry powder for oral suspension. The agency emphasizes that these formulations can become unstable after reconstitution, leading to a potential reduction in effectiveness over time.

In a Public Alert released on Friday, NAFDAC reminded all stakeholders that this directive, first introduced in March of the previous year, is still active. It applies to every locally produced and imported multi-dose artemether/lumefantrine dry powder intended for oral usage.

Previously, NAFDAC announced the suspension of product registration following results from stability assessments.

At that time, the agency indicated that it would not accept new, renewal, or alteration applications for any form of multi-dose artemether/lumefantrine dry powder for oral suspension.

This suspension encompasses all brands and manufacturers of the product.

Risk Statement

NAFDAC reported that studies indicated that reconstituted artemether/lumefantrine oral suspension is prone to instability once mixed, thus compromising its efficacy.

The agency noted that when medication effectiveness wanes, it could worsen the treated condition, raise the risk of complications, delay necessary treatments, and in extreme situations, result in death.

In its updated advisory, NAFDAC reiterated that reconstituted anti-malarial suspensions exhibit instability and may no longer achieve the expected therapeutic effect.

Formulation Alternatives

Reconfirming its earlier stance, NAFDAC stated that it would not entertain new, renewal, or variation requests for the affected formulations. Manufacturers aiming to continue producing artemether/lumefantrine formulations are advised to consider more reliable and stable alternatives, such as dispersible tablets or single-dose powders packaged in sachets.

According to NAFDAC, single-dose forms can significantly mitigate the instability concerns that arise with multi-dose suspensions once reconstituted.

Surveillance and Reporting

The established directive governs all brands of multi-dose artemether/lumefantrine dry powders for oral suspension and is applicable to all manufacturers and importers.

Healthcare professionals and the public are advised to report any suspected distribution of the banned products, as well as any substandard or counterfeit medications and medical devices, to the nearest NAFDAC office. Reports can also be made through the agency's toll-free helpline at 0800-162-3322 or via email at [email protected].