The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning to Nigerians, including healthcare providers, about a counterfeit cancer treatment drug, Phesgo 600mg/600mg/10ml, with batch number C5290S20.
The alert, contained in Public Alert No. 051/2024 on the agency’s website, followed a complaint from a doctor at the Lagos University Teaching Hospital (LUTH-NSIA).
The doctor reported a suspected counterfeit Phesgo product brought in by a patient for administration.
According to NAFDAC, the drug had not been administered at the time of the report. However, it matched the characteristics of a previously reported counterfeit batch, C3809C51, which was flagged for discrepancies.
Findings from Roche Investigation
The Marketing Authorization Holder (MAH), Roche, conducted an investigation based on images of the suspected counterfeit product, including the vial and folding box.
The findings revealed significant differences between the counterfeit and genuine materials:
- No batch number was found in the MAH database.
- Language discrepancies on the packaging.
- Missing basilisk watermark.
- Incorrect Bollino date.
- Tamper evidence labels inconsistent with authentic Roche materials.
Roche confirmed the batch as counterfeit but noted that a physical sample was unavailable for chemical analysis, limiting the investigation to visual comparisons.
Risk to Public Health
NAFDAC warned that counterfeit medicines pose severe health risks due to non-compliance with regulatory standards.
These fake products may undermine the safety, quality, and effectiveness of treatments. Phesgo 600mg/600mg Solution for Injection is used in breast cancer treatment, working to kill cancer cells and prevent their growth.
Surveillance and Safety Measures
NAFDAC has directed its zonal directors and state coordinators to intensify surveillance and remove counterfeit products from circulation. Importers, distributors, retailers, healthcare professionals, and caregivers are advised to:
- Source medical products only from authorized and licensed suppliers.
- Check the authenticity and physical condition of products.
- Avoid the importation, distribution, and sale of counterfeit products.
Reporting and Monitoring
Healthcare professionals and consumers are urged to report suspicions of substandard or counterfeit medicines to NAFDAC via:
- Toll-free number: 0800-162-3322
- Email: sf.alert@nafdac.gov.ng
- NAFDAC’s e-reporting platforms on its website or through the Med-Safety app, available for Android and iOS devices.
Reports of adverse drug reactions can also be sent to pharmacovigilance@nafdac.gov.ng. NAFDAC stated that this alert has been shared with the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS).
The agency reiterated its commitment to safeguarding public health by ensuring that counterfeit medicines are eliminated from the supply chain.
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