NAFDAC Raises Alarm Over Circulation of Fake Breast Cancer Drug in Nigeria

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 suspected fake product, Phesgo 600mg, was detected following complaints received by Roche from the Lagos University Teaching Hospital (LUTH-NSIA).

According to NAFDAC, the complaints involved suspected counterfeit batches with numbers B2346B16 and C3809C5, which were reportedly brought in 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 suspicion about its authenticity.

Phesgo 600mg is used in the treatment of breast cancer, working by killing cancer cells and slowing their growth.

NAFDAC stated that Roche, the legitimate manufacturer of the drug, conducted an assessment based on images provided by complainants, as physical samples were not submitted for analysis.

Despite the limitation, the company reportedly identified several discrepancies confirming the products were falsified, including a non-existent batch number, incorrect text, inconsistent variable data, and a Global Trade Item Number (GTIN) barcode that did not match any genuine product.

It also highlighted the absence of a tamper-evident label and noticeable differences in packaging compared to authentic versions of the drug.

“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 and compared to genuine retained samples, revealing significant differences that confirmed the falsified status of the suspected batches,” the agency stated.

Further findings showed that batch number B2346B16 has been linked to at least four confirmed counterfeit cases reported in multiple countries, including Turkey, Nigeria and the Philippines, all bearing identical fake batch 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 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,” the agency added.

It also pointed out inconsistencies in manufacturing details, noting that while the genuine product is produced by F. Hoffmann-La Roche Limited in Kaiseraugst, Switzerland, the fake versions did not clearly identify a valid production site.

In response, NAFDAC directed its zonal directors and state coordinators to intensify surveillance and ensure the removal of the counterfeit products from circulation nationwide.

The agency advised importers, distributors, healthcare providers and caregivers to exercise caution within the supply chain and avoid dealing in unverified products.

“All medical products must be obtained from authorised and licensed suppliers. The products’ authenticity and physical condition should be carefully checked,” NAFDAC stressed.

It also urged healthcare professionals and members of the public to report any suspected sale of fake or substandard medicines to the nearest NAFDAC office or through its official reporting channels.

Patients and healthcare workers were further encouraged to report any adverse reactions or side effects linked to the use of medical products via the agency’s designated platforms, including its online systems and mobile application.