Quality assessment of Diflucan(®) tablets distributed online: Diflucan(®) distributed online

BACKGROUND: Falsified medical products have been reported worldwide. Falsified medicines with poor quality are a potential health hazard. Some Internet sites advertise fluconazole (Diflucan(®)), an antifungal medicine used to treat deep mycoses, as “female Viagra(®).” AIM: The aim of this study was to investigate the authenticity and quality of Diflucan(®) tablets distributed on the Internet. METHODS: We ordered Diflucan(®) tablets via the Internet and evaluated them by visual observation, authenticity investigation, quality evaluation (quantity of the active pharmaceutical ingredient, content uniformity, and dissolution), and near-infrared and Raman scattering spectroscopy. RESULTS: We obtained 11 samples of Diflucan(®) tablets from all 11 Japanese Internet sites identified in our search. Of 11 sites, 7 advertised fluconazole as having effects on female sexual function. Ten of the Diflucan(®) samples were confirmed as genuine and one sample was falsified. The genuine Diflucan(®) samples met the specifications of all quality evaluations. The packaging, size, and color of the falsified Diflucan(®) sample obtained in this study differed from the authentic Diflucan(®) tablet. The falsified Diflucan(®) sample obtained in this study did not contain fluconazole and instead contained what appeared to be sildenafil citrate. The spectra of the falsified Diflucan(®) tablet obtained in this study differed from the authentic Diflucan(®) tablet in near-infrared and Raman scattering spectroscopy. CONCLUSION: We confirmed that one falsified Diflucan(®) tablet was distributed online. Thus, continued measures against falsified medicines are required.