The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public health warning regarding a counterfeit version of the cancer medication Herceptin® 600mg/5ml (Trastuzumab Solution for Injection), reportedly discovered in Ghana and allegedly sourced from Nigeria.
The warning, published on NAFDAC’s official website on Thursday, alerts the public and healthcare providers to the presence of the falsified product bearing batch number A8519. NAFDAC confirmed that this batch number does not match any legitimate product manufactured or distributed by Roche, the original producer of Herceptin.
“This counterfeit was reportedly presented by a patient at a hospital in Kumasi, who claimed to have purchased it in Nigeria,” NAFDAC stated.
Herceptin® 600mg/5ml injection is used to treat breast cancer in cases where the tumour tests positive for HER2.
“It may be administered alone or alongside other treatments for breast cancer, such as an aromatase inhibitor for hormone receptor-positive breast cancer or a taxane, like paclitaxel or docetaxel,” the agency explained.
How to identify the counterfeit Herceptin
NAFDAC stated that the fake Herceptin can be identified through several packaging and labelling inconsistencies, including an invalid batch number: A8519, not recognised by Roche.
Packaging flaws, such as Inconsistent font types, misplaced label text, variable data, and tamper-evident seals that differ from those used on authentic Roche products.
Risks of counterfeit medicines
NAFDAC highlighted that the counterfeit product may contain substandard, falsified, or no active pharmaceutical ingredient (trastuzumab), rendering treatment ineffective.
“Unknown chemical contents pose a risk of adverse drug reactions, including allergic reactions, systemic toxicity, or other severe health outcomes.
“Use of falsified oncology products compromises the integrity of therapeutic regimens, potentially leading to disease progression or mortality,” the agency stated.
The agency directed all its zonal directors and state coordinators to carry out surveillance and mop up the counterfeit Herceptin® 600mg/5ml solution for injection if found within the zones and states.
“Distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the distribution, sale, and use of counterfeit products.
“All medical products must be obtained from authorised/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
“Healthcare professionals and consumers are advised to report any suspicion of sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, ” the agency advised.
NAFDAC also urged healthcare professionals and patients to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on: website www.nafdac.gov.ng.
