The National Agency for Food and Drug Administration and Control has raised the alarm over the circulation of a counterfeit breast cancer drug in Nigeria, warning that the development poses serious health risks to patients.
The agency disclosed that the suspected fake product, Phesgo 600mg, was detected following complaints received by Roche from the Lagos University Teaching Hospital.
According to NAFDAC, the complaints involved suspected counterfeit batches identified as B2346B16 and C3809C5, which were reportedly presented by patients for treatment.
The agency noted that one of the batches, C3809C5, had a vial volume of about 20ml instead of the expected 10ml, raising concerns about its authenticity.
Phesgo is a medicine used in the treatment of breast cancer, designed to kill cancer cells and slow their growth.
Roche, the original manufacturer of the drug, said its investigation was limited to images of the suspected samples, as physical products were not made available.
However, it stated that the images were carefully compared with genuine samples.
The company identified discrepancies including a non-existent batch number, incorrect labelling, wrong variable data, and a Global Trade Item Number barcode inconsistent with any authentic product.
It also observed the absence of a tamper-evident seal and noticeable differences in packaging.
NAFDAC quoted Roche as saying, “Only pictures of the complaint samples were sent for investigation. Although a complete investigation was not possible, the images were scrutinised and compared with genuine retained samples, confirming the falsified status of the suspected batches.”
Further findings revealed that batch number B2346B16 has been linked to at least four confirmed counterfeit cases reported across countries including Turkey, Nigeria and the Philippines.
The agency warned that the illegal production and distribution of counterfeit medicines remain a major threat to public health, as such products do not meet required standards of safety, quality and efficacy.
It added, “The illegal marketing and distribution of counterfeit medicines risks people’s health, as they do not guarantee safety, quality and effectiveness due to non-compliance with regulatory standards.”
NAFDAC said details on the packaging of the suspected products also showed inconsistencies in manufacturing information, noting that the genuine product is produced by Roche in Switzerland.
The agency has, therefore, directed its zonal directors and state coordinators to intensify surveillance and ensure the removal of the counterfeit products from circulation nationwide.
It also urged importers, distributors, healthcare providers and caregivers to remain vigilant and source medical products only from authorised suppliers, while verifying their authenticity before use.
NAFDAC further called on healthcare professionals and the public to report any suspected cases of fake or substandard medicines through its official channels, including its toll-free lines and online platforms.
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