NAFDAC issues health alert over counterfeit cancer drug allegedly sourced from Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a high-priority public health alert following the discovery of a counterfeit batch of Herceptin® 600mg/5ml (Trastuzumab Solution for Injection) circulating in Ghana, allegedly procured from Nigeria.

The alert, published on Thursday via NAFDAC’s official website, warns health professionals and the general public of the risks associated with the falsified cancer medication, particularly in the treatment of HER2-positive breast cancer.

According to the statement, the counterfeit batch, identified by batch number A8519, was flagged by authorities in Ghana after a patient presented the drug at a hospital in Kumasi, claiming to have purchased it from Nigeria.

“The batch number A8519 does not correspond to any legitimate product manufactured or distributed by Roche, the original producer of Herceptin®,” NAFDAC confirmed.

Herceptin® (trastuzumab) is a critical monoclonal antibody used in the treatment of HER2-positive breast cancer, either as a standalone therapy or in combination with other medications such as aromatase inhibitors or taxanes (e.g., paclitaxel or docetaxel). Its efficacy depends on the presence of the active pharmaceutical ingredient, trastuzumab.

“Unknown chemical contents in falsified drugs can cause life-threatening reactions,” the agency stated, emphasizing the grave consequences of using counterfeit oncology drugs.

NAFDAC highlighted several telltale signs that can help distinguish the fake product from the authentic Roche version:

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Packaging Irregularities: Including inconsistent fonts, misaligned label text, and altered variable data.

Tamper-evident Seal Discrepancies: The counterfeit version features seals that do not match those used in Roche’s official packaging.

NAFDAC has directed all its zonal directors and state coordinators across the country to intensify pharmaceutical surveillance and initiate mop-up operations to identify and remove any counterfeit Herceptin® 600mg/5ml vials found in the market or healthcare facilities.

“Distributors, retailers, and healthcare providers must remain alert and verify the authenticity of all cancer medications through approved supply channels,” the statement read.

Use NAFDAC’s E-reporting platform to submit details of any suspected counterfeit or substandard medical product.

“Healthcare providers and patients should also report adverse events or side effects related to medicinal products to NAFDAC’s pharmacovigilance channels,” the agency added.

The agency reaffirmed its commitment to protecting public health and called for increased vigilance within the pharmaceutical supply chain, especially concerning oncology treatments, which are vital and often life-saving.

This latest development adds to growing concerns over counterfeit medicines in West Africa, particularly high-value and high-demand drugs used in critical care settings.

NAFDAC has pledged to work closely with international partners, border control agencies, and pharmaceutical stakeholders to track the source of the falsified product and prevent future incidents.