The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning to Nigerians, including healthcare professionals, about a counterfeit cancer treatment drug, Phesgo 600mg/600mg/10ml, bearing batch number C5290S20.
This alert, detailed in Public Alert No. 051/2024 on NAFDAC’s website, follows a complaint from a doctor at Lagos University Teaching Hospital (LUTH-NSIA) to the drug’s Marketing Authorisation Holder (MAH), Roche. The suspected counterfeit drug, brought in by a patient for administration, was identified before use.
NAFDAC noted that the drug matches the characteristics of an earlier counterfeit batch, C3809C51, previously reported.
“Although no physical sample was returned to Roche for investigation, images of parts of the product specifically, a Phesgo 600mg/600mg vial and a 10ml folding box were examined.
“The suspected product’s images were compared to genuine samples retained by Roche.
“Roche’s investigation identified several significant differences between the complaint sample and genuine materials, confirming the counterfeit status of the batch.
“These included: no batch number in the MAH database, discrepancies in language, missing basilisk, incorrect bollino date, and tamper evidence labels that did not match genuine Roche materials.
“Since no physical sample was available for chemical analysis, the investigation was limited to visual comparisons,” it said.
NAFDAC stated that Phesgo 600mg/600mg Solution for Injection is used in breast cancer treatment, targeting cancer cells to stop their growth. The agency warned that counterfeit medicines pose significant health risks, as they often fail to meet regulatory standards, compromising safety, quality, and effectiveness.
To combat this threat, NAFDAC directed its zonal directors and state coordinators to conduct surveillance and remove counterfeit products from their regions.
The agency urged importers, distributors, retailers, healthcare professionals, and caregivers to remain vigilant throughout the supply chain, avoiding the importation, distribution, or sale of counterfeit products.
NAFDAC further stressed the importance of sourcing medical products exclusively from authorised and licensed suppliers while carefully verifying their authenticity and physical condition.
“Healthcare professionals and consumers are urged to report any suspicions of substandard or falsified medicines or medical devices to the nearest NAFDAC office.
“Reports can also be made through NAFDAC’s contact number (0800-162-3322) or via email at sf.alert@nafdac.gov.ng.
“Additionally, healthcare professionals and patients are encouraged to report any adverse events or side effects related to the use of medicinal products or devices.
“NAFDAC provides e-reporting platforms on its website (www.nafdac.gov.ng) and through the Med-Safety app, available for download on Android and iOS devices.”
The agency said adverse effects could also be reported via email at pharmacovigilance@nafdac.gov.ng.
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