Ethical and legal aspects of the use of fake drugs for orofacial aesthetics ­ a case report

ABSTRACT

Introduction: Over the last decade, Botulinum Toxin (BT) gained space in the armamentarium of drugs used for orofacial aesthetics. The contemporary scenario of Dentistry led to new horizons within aesthetic treatments founded on the application of BT. Objective: This study aimed to report a case of fake type-A BT sold to a dentist on training for orofacial aesthetics. Material and methods: During a 16-hour training course, a dentist bought form a reference seller a "so-called" quality drug allegedly consisting of type-A BT. After suspecting of fake drug based on uncommon label and flask, the dentist sent images of the product to the laboratory responsible for registering the drug at the National Health Surveillance Agency (ANVISA). Results: The laboratory confirmed the fake drug. ANVISA blocked the commercialization, use and distribution of the product as well as made efforts to remove the available products from the market. Parallel police investigations were carried out and forensic expertise for drug profiling was accomplished ­ confirming the fake drug. Conclusion: This study drives attention to the possibility of existing fake drug commercialization to dentists dedicated to orofacial aesthetics, and the potential impact of this drugs if used in patients. Consequences might extend to penalties in the consumer relation interface, as well as in the criminal field as offense against public health.