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

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The National Agency for Food and Drug Administration and Control (NAFDAC) has warned about the circulation of a counterfeit breast cancer drug in Nigeria, saying the product poses serious health risks to patients.

The agency disclosed that the suspected fake version of Phesgo 600mg was detected after complaints were 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 seeking treatment.

The agency explained that one of the batches, C3809C5, contained about 20mL of liquid instead of the expected 10mL vial volume, raising doubts about its authenticity.

Phesgo 600mg is used in the treatment of breast cancer and works by targeting and slowing the growth of cancer cells.

Roche, the legitimate manufacturer of the drug, said only pictures of the suspected samples were provided for investigation, as physical samples were not made available. Despite the limitation, the images were examined and compared with genuine retained samples.

The company identified several discrepancies confirming 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 noticeable differences in the packaging compared to the authentic product. Chemical testing could not be conducted because the physical samples were not submitted for laboratory analysis.

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.

NAFDAC warned that the illegal production and distribution of counterfeit medicines pose a serious threat to public health because such products may not meet required standards of safety, quality, and effectiveness.

The agency noted that the genuine product is manufactured by F. Hoffmann-La Roche in Kaiseraugst, Switzerland.

In response, NAFDAC has directed its zonal directors and state coordinators to intensify surveillance and remove the counterfeit drugs from circulation across the country.

Importers, distributors, healthcare providers, and caregivers have also been urged to remain vigilant within the supply chain and ensure that medical products are sourced only from licensed and authorised suppliers.

The agency further encouraged healthcare professionals and members of the public to report any suspected sale of counterfeit or substandard medicines to the nearest NAFDAC office or through its official reporting channels.

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