NIGERIA: NAFDAC Warns Against Sales Of ‘Counterfeit’ Antimalarial Drugs

By Ameenat Hamzat, Lagos, Nigeria 

The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians to stay away from an anti-malarial drug called, Paludex tablets, which has been circulating, describing it as “counterfeit”.

The agency said the drugs, labeled as Paludex (Artemether/Lumefantrine), are manufactured by Impact Pharmaceutical Ltd, and Eco-med Pharma Ltd, Enugu, and marketed by MD Life Sciences Ltd, Enugu, and had been suspended due to their dangerous side effects.

The statement stated that the laboratory tests conducted by a World Health Organization pre-qualified laboratory in Germany and NAFDAC showed that the products contain zero percent active pharmaceutical ingredients (API), rendering them ineffective and potentially harmful.

NAFDAC also noted that the products are not on its registered database and all NAFDAC registration numbers found on the product are fake.

The statement reads: “Genuine Artemether/Lumefantrine tablets or suspension is a combination of the two medications Artemether and Lumefantrine used to treat acute, uncomplicated malaria in adults and children.

“The illegal marketing of medicines or counterfeit medicines poses a great risk to the health of people; by not complying with the regulatory provisions, the safety, quality, and efficacy of the products are not guaranteed.

“Also, poor-quality pediatric formulations or medicines in general have the potential of causing treatment failure when the API content is below the prescribed dose.

“All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the falsified products within their zones and states.”

The agency, however, urged distributors, healthcare providers, and patients to exercise caution and be alert within the supply chain to avoid the distribution, administration, and use of fake products.

“All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.”, NAFDAC noted.