NAFDAC Alerts Public To Fake Dostinex Tablets

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an urgent warning to healthcare providers, patients, and the public over falsified and parallel imported batches of Dostinex 0.5mg Tablets.

Pfizer Nigeria Ltd, the Marketing Authorisation Holder (MAH) of the products, has confirmed the presence of falsified and parallel unregistered imported versions of these products. According to Pfizer Nigeria Ltd, the legitimate product has been registered but has not yet been imported into Nigeria.

Dostinex 0.5mg treats conditions caused by excess prolactin secretion by reducing prolactin levels in the body.

The agency said potency of the products is highly dependent on complying with regulatory requirements. Falsified, unlicensed, and unregistered medicines present significant risks to public health because these products have not been evaluated by NAFDAC.

It added that the quality, safety, and efficacy of these products cannot be guaranteed.

“NAFDAC remains steadfast in its mandate to protect public health through ongoing surveillance to guarantee the quality, safety, and efficacy of medicines across Nigeria.

“To this end, the agency has instructed all zonal directors and state coordinators to immediately launch intensified monitoring efforts and remove any identified unregistered products from circulation within their jurisdictions.
Meanwhile, distributors, retailers, healthcare professionals, and caregivers are urged to pay close attention to the discrepancies outlined earlier.

“They must exercise utmost caution and vigilance throughout the supply chain to prevent the distribution, sale, or use of these suspect items. Importantly, all medical products should only be sourced from authorized, licensed suppliers, with careful verification of authenticity and physical condition.

“In addition, healthcare professionals are specifically advised to promptly review stocks in hospitals, clinics, and pharmacies. Any suspected falsified medicines should be reported immediately to the nearest NAFDAC office,” it stated.

It, therefore, urged healthcare providers and patients to report adverse events via NAFDAC’s e-reporting platforms on www.nafdac.gov.ng, the Med-safety app, or [email protected].