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The National Agency for Food and Drug Administration and Control, NAFDAC, has raised concerns 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 fake product, Phesgo® 600mg, was detected following complaints received by Roche from the Lagos University Teaching Hospital (LUTH-NSIA).
The complaints involved suspected counterfeit batches with numbers. B2346B16 and C3809C5, which were reportedly brought in by patients for treatment.
According to the statement by NAFDAC, one of the batches, C3809C5, had a vial volume of about 20mL instead of the expected 10mL, raising suspicion about its authenticity.
Phesgo 600mg is a medicine used in the treatment of breast cancer. It works by killing cancer cells and slowing down their growth.
Roche, the legitimate manufacturer of Phesgo, stated that only pictures of the samples were made available for investigation, as physical samples were not provided. Despite this limitation, the images were carefully examined and compared with genuine retained samples.
The company identified several differences that confirmed the products were falsified, including a batch number that does not exist in its database, incorrect text, wrong variable data, and a Global Trade Item Number (GTIN) barcode that does not match any genuine product.
It also noted the absence of a tamper-evident label and visible differences in packaging when compared to the original product. Chemical testing could not be carried out because the physical samples were not submitted for analysis.
“Only pictures of the complaint samples were sent to Roche by the complainants for investigation. Although a complete investigation was not possible, the pictures provided were scrutinised by Roche and compared to genuine retained samples. The investigation identified the following significant differences between the complaint sample pictures and the genuine materials, which confirmed the falsified status of the suspected counterfeit batches.” NAFDAC said
Further findings revealed that batch number B2346B16 has been linked to at least four confirmed counterfeit cases reported in multiple countries, including Turkey, Nigeria, and the Philippines. Each of the reported cases contained the same fake batch number and misleading details.
NAFDAC warned that the illegal production and distribution of counterfeit medicines pose a major threat to public health, as such products do not meet the required standards of safety, quality, and effectiveness.
”The illegal marketing and distribution of counterfeit medicines risks people’s health, as they do not guarantee the safety, quality, and efficacy of the products due to non-compliance with regulatory standards,” NAFDAC stated
Details of the suspected counterfeit products show inconsistencies in manufacturing information, with the stated production site not clearly identified in the images reviewed. The genuine product, however, is manufactured by F. Hoffmann-La Roche Limited in Kaiseraugst, Switzerland.
In response, NAFDAC has directed all zonal directors and state coordinators to intensify surveillance and remove the counterfeit products from circulation across the country.
Importers, distributors, healthcare providers, and caregivers have been advised to remain cautious within the supply chain and avoid dealing in unverified products. The agency stressed that all medical products should be sourced only from licensed and authorised suppliers, while their authenticity and physical condition must be carefully checked before use.
“All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.” NAFDAC stressed
Healthcare professionals and members of the public are also encouraged to report any suspected sale of fake or substandard medicines to the nearest NAFDAC office. Reports can also be made via the agency’s toll-free line, email, or official reporting platforms.
Similarly, patients and healthcare workers are urged to report any adverse reactions or side effects linked to the use of medical products through NAFDAC’s reporting channels, including its online platforms and mobile application.
NAFDAC raises alarm over fake cancer drug circulating in Nigeria
