NAFDAC Reaffirms Ban on Multi-Dose Anti-Malaria Suspension Over Stability Risks

The National Agency for Food and Drug Administration and Control has repeated its directive stopping registration of multi-dose artemether/lumefantrine dry powder for oral suspension, saying the product can become unstable after it is mixed and may no longer work as expected.

In a public alert issued on Friday, NAFDAC said the decision it first announced in March last year is still in force. The agency said the restriction covers both locally produced and imported multi-dose artemether/lumefantrine oral suspensions.

NAFDAC said earlier stability findings showed that the reconstituted suspension may lose potency over time. Because of that risk, the regulator said it is not accepting any new, renewal or variation applications tied to the affected product line.

According to the agency, once an anti-malarial medicine loses effectiveness, patients may face worsening illness, delayed recovery and a higher chance of complications. It added that severe outcomes, including death, can occur when treatment fails.

NAFDAC said the measure applies across all brands, manufacturers and importers involved in multi-dose artemether/lumefantrine dry powder for oral suspension.

The regulator advised pharmaceutical companies that still want to produce artemether/lumefantrine medicines to move to options it considers more stable. It listed dispersible tablets and powders or granules packed in sachets for single-dose use as preferred alternatives.

The agency said single-dose packaging helps reduce the instability concerns linked to keeping reconstituted suspension over multiple uses.

For implementation, NAFDAC called on health workers, pharmacists and members of the public to stay alert and report any suspected sale of the discontinued product.

It asked Nigerians to report suspected substandard or falsified medicines and devices through nearby NAFDAC offices, the toll-free line 0800-162-3322, or by email at [email protected].

The renewed warning indicates the regulator is continuing surveillance in the anti-malarial market as it pushes manufacturers and importers to comply with the directive. Health-sector stakeholders are expected to align procurement and dispensing practices with the updated enforcement position to avoid continued circulation of formulations the agency considers unsafe after reconstitution.