NAFDAC Warns Against Falsified Dostinex Tablets in Nigeria

By Naija Enquirer Staff

The National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned the public, particularly healthcare providers, over the circulation of falsified and parallel imported batches of Dostinex 0.5mg Tablets in Nigeria.

According to the agency, Pfizer Nigeria Ltd, the Marketing Authorisation Holder (MAH) of the product, confirmed the presence of falsified and unregistered imported versions of the medication within the country.

Pfizer Nigeria Ltd further clarified that although the legitimate product has been registered, it has not yet been officially imported into Nigeria.

Medical Use and Public Health Risk

Dostinex 0.5mg is prescribed to treat conditions caused by excessive prolactin secretion by lowering prolactin levels in the body.

NAFDAC warned that the potency and safety of medicines depend heavily on strict compliance with regulatory requirements.

“Falsified, unlicensed, and unregistered medicines present significant risks to public health because these products have not been evaluated by NAFDAC. Therefore, the quality, safety, and efficacy of these products cannot be guaranteed,” the agency stated.

The agency reaffirmed its commitment to protecting public health through sustained surveillance and regulatory enforcement across the country.

Regulatory Directives

NAFDAC has directed all zonal directors and state coordinators to immediately intensify monitoring activities and remove any identified unregistered products from circulation within their jurisdictions.

Distributors, retailers, healthcare professionals, and caregivers have also been urged to exercise heightened vigilance across the supply chain to prevent the distribution, sale, or use of suspect products.

The agency emphasized that all medical products should only be sourced from authorized and licensed suppliers, with proper verification of authenticity and physical condition.

Call for Reporting

Healthcare professionals have been specifically advised to conduct immediate reviews of medicine stocks in hospitals, clinics, and pharmacies. Any suspected falsified medicines should be reported to the nearest NAFDAC office without delay.

Healthcare providers and patients are also encouraged to report adverse events through NAFDAC’s e-reporting platforms at www.nafdac.gov.ng, via the Med-Safety App, or by email at [email protected].