The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning to Nigerians, including healthcare professionals, regarding a fake cancer treatment drug, Phesgo 600mg/600mg/10ml, bearing batch number C5290S20. This alert is detailed in public notice No. 051/2024, which is accessible on the agency’s website.
NAFDAC has stressed the importance of acquiring medical products only from authorised and licensed suppliers, with thorough verification of their authenticity and condition. The Phesgo 600mg/600mg, with batch number C5290S20, was reportedly brought in by a patient for treatment.
NAFDAC clarified that Phesgo 600mg/600mg Solution for Injection is used to treat breast cancer by targeting and destroying cancer cells while preventing their growth. The agency has directed all NAFDAC zonal directors and state coordinators to monitor and remove counterfeit products from their respective zones and states.
NAFDAC also urged importers, distributors, retailers, healthcare professionals, and caregivers to exercise caution and remain vigilant across the entire supply chain, ensuring they do not import, distribute, or sell counterfeit products.
NAFDAC has stated that the product notification will be shared with the World Health Organisation (WHO) Global Surveillance and Monitoring System (GSMS) for further awareness and tracking. The agency is urging both healthcare professionals and consumers to report any suspicions of substandard or counterfeit medicines or medical devices to the nearest NAFDAC office.
In addition, healthcare providers and patients are encouraged to report any adverse events or side effects related to the use of any medicinal products or medical devices they encounter. This is a critical step to ensure public safety and the integrity of medical treatments.
Complaints Received by Roche
NAFDAC also reported that Roche, the Marketing Authorisation Holder (MAH) for Phesgo, received a complaint from a doctor at the Lagos University Teaching Hospital (LUTH-NSIA) regarding the possible counterfeit status of the product.
At the time the complaint was made, the product had not yet been administered to any patient, but it resembled the characteristics of a previously identified counterfeit batch, C3809C51. Although no physical sample of the suspected counterfeit was returned to Roche for thorough investigation, images of parts of the product were submitted for review.
These images included a Phesgo 600mg/600mg vial and a 10ml folding box. As no physical sample was available for chemical analysis, the investigation relied on visual comparisons between the suspected product and the genuine samples held by Roche. Roche’s subsequent investigation revealed several notable differences between the suspected counterfeit and the genuine product, confirming that the batch in question was indeed counterfeit.
Some of the key discrepancies included the absence of a batch number in the MAH database, issues with the language used on the packaging, missing basilisk (a feature on the genuine packaging), an incorrect bollino (authentication date), and tamper-evident labels that did not align with those used on authentic Roche products.
These findings strongly supported the conclusion that the product was counterfeit, reinforcing the importance of vigilance in the supply chain to protect public health.
