Descriptive analysis of notifications of adverse events of cosmetic products registered in Notivisa, from 2006 to 2018

• Autor(a) principal: Penna Teixeira, Ana Paula Coelho
• Data de Publicação: 2019
• Outros Autores: de Almeida, Andreia Carla, Melo, Danilo Feitoza, Leitão, Leonardo Oliveira, Silva, Luis Henrique Calazans
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1384
• topic: Brazilian Health Surveillance Agency; Brazil; Cosmetics; Adverse Effect; Health Surveillance; Cosmetovigilance; Agência Nacional de Vigilância Sanitária; Brasil; Cosméticos; Efeitos Adversos; Vigilância Sanitária; Cosmetovigilância

Introduction: The National Health Surveillance Agency (Anvisa) defines cosmetovigilance as the set of measures that allows assessing the risk of occurrence of undesirable events attributed to the use of cosmetic products, including the capture of adverse events (AE). From 2006 Anvisa began to receive EA notifications involving cosmetic products, with the implementation of the Sanitary Surveillance Notification System (Notivisa). Objective: This study analyzed the notifications of adverse effects related to the use of cosmetic products, registered in Notivisa, from 2006 to 2018. Method: This is a quantitative, descriptive and retrospective study whose database was extracted from the Notivisa system, nationwide, from November 2006 to December 2018. Results: We identified 367 adverse effects involving cosmetic products with an average of 31 notifications per year. Reports of adverse effects came mainly from the Southeast (48.1%; 176) and South (25.1%; 92) regions of the country with a predominance of females (66.2%; 243). It was observed that the citizen is the on ewho most reports adverse effects (58.0%; 213) related to cosmetic products, with more complaints about infant and geriatric diapers (15.0%; 26), facial / body creams (14.1%; 24), hair straighteners (17.8%; 35) and sunscreens (14.8%; 29). The most common adverse effects were irritation (46.0%; 17), allergy (30.5%; 11) and burning (30.5%; 11). The reported effects are mostly performed by female citizens from the richest regions of the country, attributed to products of daily use and characterized by the presence of irritation, allergy and burning. Conclusions: These results have demonstrated the need to improve Anvisa’s Cosmetovigilance System, defining strategies for adherence to adverse effect reports, as well as the adoption of a causal assessment method appropriate to the specificities of cosmetic products.