The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a critical alert concerning a suspected counterfeit batch of Phesgo® 600mg/600mg injection in Nigeria.
The alert specifically identifies the problematic batch as C3809C51.
PLATFORM TIMES reports that Phesgo® is a combination drug used for the treatment of HER2-positive breast cancer. It combines two active ingredients, pertuzumab and trastuzumab, along with hyaluronidase. This medication is typically used in combination with chemotherapy.
This alert follows a report from Roche, the Marketing Authorisation Holder of Phesgo®, which highlighted a complaint received from a pharmacist. The complaint pointed to the suspected counterfeit nature of the batch, although no physical sample was returned for verification. However, photographic evidence provided crucial insights into the discrepancies between the counterfeit and genuine products.
Key differences identified include mismatched batch numbers, incorrect tamper evidence labels, and inconsistencies in the dimensions and labeling of the vials. Notably, the counterfeit product was found to be a solid form, unlike the genuine liquid form of Phesgo®. This solid counterfeit closely resembles other known counterfeit cases reported in Libya, particularly in terms of batch numbers and the use of Bollino labels.
In response, NAFDAC has instructed its regional coordinators to intensify surveillance and swiftly remove any counterfeit products from the market. The agency has also urged importers, distributors, and healthcare providers to diligently verify the authenticity of Phesgo® products. They are encouraged to report any suspicions of counterfeit products to NAFDAC immediately.
Healthcare professionals and consumers are also advised to report any suspected counterfeit products or adverse effects directly to NAFDAC. Reports can be made via phone, email, or online platforms, ensuring that the public is well-informed and protected from potentially harmful counterfeit drugs.
NAFDAC’s alert will be shared with the World Health Organization (WHO) Global Surveillance and Monitoring System, further underscoring the seriousness of the situation and the importance of international cooperation in combating counterfeit pharmaceuticals.
This alert is a crucial reminder of the need for vigilance in the pharmaceutical supply chain and the importance of ensuring that all medications distributed in Nigeria meet the required safety and efficacy standards. The public is urged to stay informed and cautious, particularly with high-value and life-saving medications like Phesgo®.
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