NAFDAC warns of counterfeit breast cancer drug Phesgo being circulated in Nigeria

NIGERIA—The National Agency for Food and Drug Administration and Control (NAFDAC) has warned healthcare providers and the public about suspected counterfeit batches of Phesgo 600mg, a medicine used to treat breast cancer.

The agency published this alert after receiving complaints from Roche, the product’s marketing authorization holder.

Roche revealed that batch number B2346B16 has been linked to at least four confirmed counterfeit cases across multiple countries, including Nigeria, Turkey, and the Philippines.

All cases displayed identical false information, indicating a coordinated distribution of falsified products.

Discovery at Lagos Teaching Hospital

The complaints originated from Lagos University Teaching Hospital (LUTH-NSIA), where patients brought in suspected counterfeit products for administration.

Healthcare workers flagged two batch numbers: B2346B16 and C3809C5.

In one instance, the vial volume for batch C3809C5 measured approximately 20 milliliters instead of the expected 10 milliliters, raising immediate concerns.

However, patients provided only photographs of the samples to Roche for investigation, limiting the scope of analysis.

Despite the absence of physical samples, Roche scrutinized the images and compared them with genuine retained samples, identifying several discrepancies that confirmed the products were falsified.

Key indicators of counterfeit products

The investigation revealed multiple red flags that distinguished the fake products from authentic ones.

The batch numbers did not exist in Roche’s database, and the text and variable data contained errors.

The Global Trade Item Number (GTIN) did not match any authentic product in the company’s records.

Additionally, the tamper-evident label was missing, and packaging materials showed notable differences from genuine products.

Roche noted that chemical analysis could not be conducted because no physical samples were submitted for testing.

Phesgo 600mg contains pertuzumab and trastuzumab, which target and inhibit the growth of cancer cells in breast cancer patients.

Regulatory response and safety measures

NAFDAC emphasized that counterfeit medicines pose serious health risks because they do not meet required standards of safety, quality, and efficacy.

The agency directed all zonal directors and state coordinators to conduct surveillance and remove counterfeit products from their jurisdictions.

The agency urged importers, distributors, retailers, healthcare professionals, and caregivers to exercise vigilance throughout the supply chain.

All medical products should be sourced only from authorized and licensed suppliers, with careful verification of authenticity and physical condition.

Healthcare professionals and the public can report suspected cases of substandard or falsified medicines to the nearest NAFDAC office or through its toll-free line.

Reports can also be submitted via the agency’s website, pharmacovigilance platforms, and Med Safety application.

Recent regulatory actions

This warning follows a series of recent regulatory actions by NAFDAC targeting unsafe medical products in Nigeria.

Earlier this week, the agency recalled all batches of MR.7 Super 700000 capsules after discovering undeclared pharmaceutical ingredients that posed safety concerns.