…the fake Herceptin 600mg is labelled with F. Hoffmann-La Roche Ltd.
Lagos, Nigeria — The iNews Times reports that the National Agency for Food and Drug Administration and Control (NAFDAC) has issued a nationwide alert over the circulation of a confirmed Fake Herceptin 600mg batch in Nigeria. The warning follows an official communication from Roche Nigeria, confirming that a fake batch of the life-saving cancer drug, Herceptin 600mg, with batch number A8519B34, has been detected in Lagos State.
In a statement released on Monday, NAFDAC highlighted that the alert is aimed at both healthcare professionals and the general public to prevent exposure to the dangerous fake product. Herceptin, also known by its generic name trastuzumab, is a prescription medicine commonly used in treating specific types of breast and stomach cancers. It functions by slowing or stopping the growth of cancer cells and is usually administered through injection or infusion, often alongside chemotherapy.
The issue came to light after a concerned customer reported that a pharmacist in Lagos offered Herceptin 600mg at an unusually low price of N50,000, significantly below the standard market rate. According to NAFDAC, this prompted further investigation by Roche Nigeria, the Marketing Authorization Holder (MAH).
“According to the Marketing Authorization Holder, the report of a fake Herceptin 600mg batch was received as a complaint from a customer. The counterfeited batch of the product was said to have been offered to a customer by a pharmacist in Lagos at a significantly lower price of N50,000 compared to the standard rate,” the agency stated.
Upon investigation, Roche Nigeria compared images of the suspected fake Herceptin 600mg with genuine packaging. The results revealed major discrepancies, including incorrect artwork, a wrong expiry date, and an inaccurate 2D matrix code, clear indicators that the batch was fake.
“The MAH (Roche Nigeria) compared the pictures of the fake Herceptin 600mg provided by the complainant to the genuine packaging material of Herceptin 600 mg. The comparison revealed significant differences from genuine packaging material,” NAFDAC added.
Efforts to trace the batch proved futile, as the batch number A8519B34 does not exist in the official records of the manufacturer. The agency also confirmed that chemical analysis could not be conducted since the physical sample was not available.
NAFDAC warned that counterfeit oncology drugs pose serious health risks to patients. These risks include treatment failure, disease progression, severe adverse events, and even death. “Counterfeit oncology medicines may contain incorrect or no active ingredients, harmful contaminants, or incorrect dosage strength. This may result in treatment failure, disease progression, serious adverse events, or death,” the statement said.
The agency provided specific details to aid identification of the counterfeit product. The fake Herceptin 600mg is labelled with F. Hoffmann-La Roche Ltd, Kaiseraugst, Switzerland, as the manufacturer, carries batch number A8519B34, a manufacturing date of January 2024, and an expiry date of November 2026. NAFDAC clarified that the genuine Herceptin 600mg is produced at Roche’s Basel-Kaiseraugst facility in Switzerland.
Following the discovery, NAFDAC has directed all zonal directors and state coordinators to intensify surveillance and remove any counterfeit stock from circulation.
“All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the counterfeit product within the zones and states,” the agency said.
Healthcare providers, importers, distributors, retailers, and caregivers have also been urged to exercise extreme caution. Only medical products from licensed and authorised suppliers should be used, with careful inspection for authenticity and proper packaging.
The public and healthcare professionals are encouraged to report any suspected counterfeit or substandard medicines to the nearest NAFDAC office or via official communication channels. The agency also stressed the importance of reporting adverse events or side effects related to medical products through its e-reporting platforms or Reforms Unit.
Additionally, the alert will be shared on the World Health Organization’s Global Surveillance and Monitoring System (GSMS) to strengthen international monitoring and prevent wider circulation of the counterfeit drug.
NAFDAC’s warning serves as a crucial reminder for all Nigerians to remain vigilant against counterfeit medicines, which can have fatal consequences, especially in the treatment of cancer.
