NAFDAC Issues Alert on Counterfeit Breast Cancer Drug Phesgo in Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) has warned the public and healthcare providers about suspected counterfeit batches of Phesgo 600mg, a medication used in breast cancer treatment. The alert follows complaints received by the drug’s Marketing Authorisation Holder, Roche.

The initial reports came from patients at the Lagos University Teaching Hospital (LUTH-NSIA) who brought in suspected products for treatment. Two batches, B2346B16 and C3809C5, were flagged. In one case, batch C3809C5 vials contained about 20 millilitres instead of the standard 10 millilitres. Roche reviewed photographs of the vials and identified multiple discrepancies compared with genuine samples, including non-existent batch numbers, incorrect text and variable data, mismatched GTIN codes, missing tamper-evident seals, and differences in packaging materials. No chemical testing could be conducted due to the absence of physical samples. Roche confirmed that batch B2346B16 has been linked to at least four verified counterfeit cases across Nigeria, Turkey, and the Philippines.

Phesgo contains pertuzumab and trastuzumab, which inhibit the growth of breast cancer cells. NAFDAC emphasized that counterfeit medicines carry significant health risks, as they do not meet required safety, quality, or efficacy standards. The agency has instructed all zonal directors and state coordinators to conduct surveillance and remove counterfeit products within their regions.

Importers, distributors, retailers, healthcare professionals, and caregivers are urged to remain vigilant, source medicines only from licensed suppliers, and verify product authenticity. Suspected cases of substandard or falsified drugs should be reported to the nearest NAFDAC office, via the agency’s toll-free line, website, or pharmacovigilance platforms. Adverse reactions or side effects should also be reported through NAFDAC’s official channels, including the Med Safety app.

This alert comes amid ongoing regulatory enforcement by NAFDAC. Earlier this week, the agency recalled all batches of MR.7 Super 700000 capsules after tests revealed undeclared active ingredients, including sildenafil and tadalafil, which pose potential health risks.