Counterfeit Breast Cancer Drug Sparks Global Health Alert
Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public warning about counterfeit batches of Phesgo 600mg, a critical medication used in treating breast cancer. The alert, published on Tuesday, follows investigations into suspected fake versions of the drug linked to multiple countries, including Nigeria, Turkey, and the Philippines.
The counterfeit cases first came to light after complaints were lodged by patients at the Lagos University Teaching Hospital (LUTH-NSIA), who brought in suspected fake Phesgo for administration. Two specific batch numbers, B2346B16 and C3809C5, were flagged during the investigation. One alarming discovery was that the vial volume for batch C3809C5 was approximately 20 millilitres, double the expected 10 millilitres.
Roche, the pharmaceutical company behind Phesgo and its Marketing Authorisation Holder, was notified of the issue. However, the investigation was hampered as only photographs of the samples were provided, limiting the scope of physical or chemical analysis. Despite this, Roche conducted a thorough visual comparison with genuine samples and confirmed that the products were falsified. Key discrepancies included non-existent batch numbers, incorrect text, mismatched Global Trade Item Numbers (GTIN), and missing tamper-evident labels.
The company further revealed that batch B2346B16 has been tied to at least four confirmed counterfeit cases across multiple countries. The fakes bear identical false information, raising concerns about a coordinated international counterfeit operation.
Health Risks and Regulatory Action
Phesgo 600mg, a combination of pertuzumab and trastuzumab, is a life-saving medication designed to target and inhibit the growth of HER2-positive breast cancer cells. Counterfeit versions, however, pose grave risks to patients. NAFDAC emphasized that such products fail to meet safety, quality, and efficacy standards, potentially endangering lives.
In response, NAFDAC has directed its zonal directors and state coordinators to conduct nationwide surveillance and remove counterfeit products from circulation. The agency urged importers, distributors, retailers, healthcare professionals, and caregivers to remain vigilant and ensure that all medical products are sourced from authorised and licensed suppliers.
“Healthcare providers and the public are advised to carefully inspect the authenticity and physical condition of medications before use,” NAFDAC stated. The agency also encouraged reporting suspected cases of substandard or falsified medicines through its toll-free line, website, or pharmacovigilance platforms.
Broader Regulatory Efforts
This warning is part of NAFDAC’s ongoing efforts to combat unsafe and unapproved medical products in Nigeria. Earlier this week, the agency announced the recall of all batches of MR.7 Super 700000 capsules after the US Food and Drug Administration (FDA) found undeclared ingredients, including sildenafil and tadalafil—substances commonly used in erectile dysfunction treatments.
NAFDAC cautioned that the inclusion of these undisclosed phosphodiesterase (PDE-5) inhibitors renders the capsules unapproved and potentially harmful. The recall underscores the agency’s commitment to protecting public health amid a surge in counterfeit and unregulated medical products.
What Patients and Providers Can Do
Patients relying on Phesgo or other critical medications are urged to verify the authenticity of their prescriptions. Healthcare providers must double-check batch numbers and packaging details, reporting any irregularities to NAFDAC immediately.
“The circulation of counterfeit medicines is not just a Nigerian problem—it’s a global threat to public health,” said Dr. Adeolu Olowokere, a Lagos-based oncologist. “Patients battling breast cancer depend on effective treatments, and fake drugs can severely compromise their recovery.”
As NAFDAC intensifies its crackdown on counterfeit medicines, the agency remains a key player in safeguarding Nigeria’s healthcare system. Its proactive measures highlight the urgent need for global collaboration to combat the proliferation of fake medical products.
— Reported by Nexio News
