ABSTRACT
Background:Usage of cosmetic products has been increased significantly in last few decades. Their usage has increased beyond the purpose of beautification. The definition of cosmetic product varies widely amidst different countries. Increased concern of physical appearance in population throughout the globe has been taken as an advantage by the cosmetic industries. Increased usage of different personal care products for prolonged period of time leads to exposure of the human body to wide variety of chemicals which maylead to adverse effects. Heavy metals have been found in certain cosmetic products which not only lead to dermatological but systemic adverse effects too. Further to this, pharmacologically active agents have been found in anti aging products. These cosmeceutical agents may possess chemical agents which are toxic to human body. Western countries have laid certain regulatory guidelines for manufacturing, labelling and marketing of cosmetic products. Cosmetovigilance ensures appropriate and safe use of cosmetic products. In India, Drugs and Cosmetic Act governs the regulations for the cosmetic products. Need of formal adverse event reporting system as well as strict regulatory guidelines for cosmetic products are required to curtail the adverse health outcomes due to cosmetic products.
ABSTRACT
Background: Adverse reactions (ARs) are one of the most important causes of morbidity, hospitalization and increased healthcare cost. ARs to cosmetics are often underreported. The aim of our study was to assess the incidence, nature, causality and the outcome of ARs to cosmetics.Methods: This was a prospective observational study conducted in a dermatology outpatient clinic of a secondary care hospital of UAE. All the patients with suspected AR to cosmetics and reporting to dermatology clinic were included. The required data were collected from patient case files, patients and their caretakers. The Colipa causality scale was used to assess the causality of reported ARs.Results: The incidence of cutaneous ARs to cosmetics was 1.58%. Shampoo was the most common [7 (16.6%)] type of cosmetic suspected to cause AR, followed by face cream [6 (14.2%)]. The most common cutaneous AR to cosmetics observed in our study was rash and pruritus [13 (30.9%)] followed by itching [10 (23.8%)]. The majority of the cutaneous ARs in our study were on scalp, face and lower limbs each contributing about 21.4%. Causality assessment reveals that 16 (38%) of the cutaneous ARs were very likely type, while 25 (60%) of ARs were of not clearly attributable to use of cosmetic/s.Conclusions: Good number of the adverse reactions documented were mild in nature. Majority of the adverse reactions were not clearly attributable type. The results of this study can form a basis for creating awareness regarding the most common cosmetics associated with ARs. The study fosters the role of initiating cosmetovigilance activities.
ABSTRACT
Los cosméticos son productos de venta libre y de uso diario para los consumidores, quienes restan importancia a las implicaciones de salud que pueden experimentar a causa de los mismos. Es necesario monitorear la postcomercialización de estos productos, ya que en los años recientes se han visto asociados a reacciones adversas; de esta manera nace el concepto de cosmetovigilancia y la necesidad de implementar sistemas para llevarla a cabo. Esta revisión sistemática encontró un limitado número de publicaciones que informen del estado actual y de las tendencias de la cosmetovigilancia, aunque fue posible definir el concepto e identificar los países que lo han desarrollado e implementado, siendo la Unión Europea quien lidera estos aspectos, contando con la participación de distribuidores, industrias, profesionales de la salud y consumidores. La cosmetovigilancia es un campo de la vigilancia sanitaria que se encuentra aún en desarrollo y por lo tanto, es importante continuar con la indagación al respecto, hasta lograr un mecanismo de vigilancia eficiente y útil tanto para los países miembros de la Unión Europea, como para aquellos que aún se encuentran en vías de desarrollo, como Colombia.
Cosmetics are free sale products that are used daily by consumers who usually not concerned about the possible health implications by the use of these products. It is necessary to perform a post-sale monitoring for these products, since in recent years they have been associated with adverse reactions. For this reason was built the cosmetovigilance concept as well as the need to implement a system to perform this task. This systematic review found a limited number of publications about the current cosmetovigilance status and tendencies at world level. Nevertheless, it was possible to define the concept and identify the countries that have developed and implemented this system. European Union is the leader in this topic, with investigations, regulations, development and implementation of an harmonized cosmetovigilance system. These activities include the participation of distributors, manufacturing industries, health professionals and consumers. Cosmetovigilance is a sanitary vigilance area that is still under development and therefore it is important to keep on investigating about this topic until achieve an efficient and useful system, for both European Union members and developing countries such as Colombia.