Patch testing with own cosmetics—a prospective study of testing and reporting of adverse effects to the Swedish Medical Products Agency

Tammela, Monica; Lindberg, Magnus; Isaksson, Marléne; Inerot, Annica; Rudel, Jana; Berne, Berit

doi:10.1111/j.1600-0536.2012.02058.x

Cited by 13 publications

(5 citation statements)

References 15 publications

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“…The reported adverse events in a study conducted in Ethiopia were allergic reactions (36%), acne (16%), and skin thinning (9.6%) [ 14 ]. Another study reported events such as itching (68.9%), redness (61%), acne (14.2%), and scaling of hair (19.3%) by frequent use of products classified as cosmetics [ 25 ]. Factors such as seasonal variations, hormonal imbalance, bacterial, parasite, and fungal infection, and psychological issues such as stress and unhygienic practices can be responsible for ACRs [ 26 ].…”

Section: Discussionmentioning

confidence: 99%

Analysis and Reporting of Adverse Drug Reactions of Cosmetics at a Tertiary Care Hospital

Paikray,

Bisoyi,

Rout

et al. 2024

Cureus

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Background and objectives Cosmetovigilance is a term used for the activities related to the collection, evaluation, and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. It is now considered a part of the public health system to determine the toxicity of cosmetic products. India has a pharmacovigilance system that monitors adverse drug reactions. Adverse effects due to the use of cosmetic products are undernumbered and a rigorous vigilant system is necessary to check the unmet needs of our country. Hence keeping the above in view, the study was conducted. Material and methods Patients of any gender, aged above 18 years, reporting adverse reactions to cosmetics at the study site were included in the study. The adverse reactions to cosmetics were noted. The causality of the observed adverse cosmetic reactions (ACRs) was done by the European Cosmetic, Toiletry and Perfumery Association (COLIPA) and Product Lifecycle Management (PLM) methods. Results A total of 120 patients were included in the study. The cosmetic products used by the patients were mainly face care products (n=144) followed by make-up care products (n=126). A total of 121 types of ACRs were reported. The majority of the ACRs were caused by products involved in facial care (62; 51.2%) followed by personal care products (20; 16.5%). In the causality assessment of the ACRs using the COLIPA method, 49.4% of patients were categorized as likely, and using the PLM method, 59% of the events were categorized as probable. Conclusion Most of the ACRs were caused by face care products and acne was reported as the most frequently occurring ACR. Awareness programs regarding the reporting of ACRs should be encouraged among cosmetic users and stakeholders.

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Section: Discussionmentioning

confidence: 99%

Analysis and Reporting of Adverse Drug Reactions of Cosmetics at a Tertiary Care Hospital

Paikray,

Bisoyi,

Rout

et al. 2024

Cureus

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“…National platforms dedicated to the reporting of adverse reactions are essential to better collect vigilance data [4]. Further efforts should be made to facilitate the report of reactions related to the use of dermo-cosmetic products by physicians and consumers [27,32,33]. Pierre Fabre Laboratories regularly hold sessions of information for health care professionals (e.g.…”

Section: Discussionmentioning

confidence: 99%

Surveillance of dermo-cosmetic products: a global cosmetovigilance system to optimise product development and consumer safety

Ribet¹,

Claudin²,

Brinio³

et al. 2021

European Journal of Dermatology

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Background: In the absence of formal marketing authorisation, the manufacturers of cosmetic products are responsible for their compliance with the cosmetic regulations. Objectives: To present the key features of a structured, reactive, and rigorous global cosmetovigilance system through practical examples. Materials & Methods: During clinical development, adverse reactions are collected formally and analysed by cosmetovigilance experts. After commercialisation, information on reported adverse reactions is sought directly from the consumers. The results of allergological investigations are systematically requested. Preand post-marketing cases are analysed along with other sources of information (e.g. monitoring of the literature) to detect safety signals per product and per ingredient. A cosmetovigilance index (CVI) is calculated for each formula, based on the number of cases, causality level and number of commercialised units. Updated periodically, it is used to detect signals and select the best tolerated formulas to help formulating new products. Results: Examples of safety issues raised during development or after commercialisation, and corresponding corrective actions, are presented. These actions include (but are not limited to) a safety watch to closely monitor adverse reactions, the modification of the formula or a change in the packaging. Cosmetovigilance data also impact future product development, as illustrated by the work done on sunscreens. Conclusion: Through the rigorous collection and analysis of adverse reactions during development and after commercialisation, the safety of dermo-cosmetic products can be improved by taking the appropriate corrective actions, monitoring their effectiveness and optimising future product development by focusing on the best tolerated formulas.

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“…Los documentos que se seleccionaron para el estudio fueron clasificados según el tipo de información que contenían como: "normatividad", "artículo científico", "fichas de notificación", "guías o manuales", "trabajos de grado" y otra categoría que incluía "varios", en donde se encuentran por ejemplo, relatorías y simposios acerca de normatividad. ) ha publicado artículos científicos sobre la realización de estudios piloto de un sistema de cosmetovigilancia con el objetivo de monitorear el riesgo de ocurrencia de efectos graves no deseados atribuibles a cosméticos, incluyendo la presentación de informes y el registro sistemático de esos efectos, seguido por el análisis y la evaluación de los datos [7,[55][56][57][58]. Estos estudios demuestran que a pesar que las regulaciones afirman que los productos cosméticos deben ser seguros, estos productos pueden causar efectos graves no deseados y además, que sólo un pequeño porcentaje de los consumidores que presentan un efecto grave no deseado, informan a un profesional de la salud [32,55,56].…”

Section: Descripción De La Documentación Encontradaunclassified

Cosmetovigilancia: un estudio de alcance

Guevara

Lang

Novoa

2016

Rev. Colomb. Cienc. Quim. Farm.

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Los cosméticos son productos de venta libre y de uso diario para los consumidores,quienes restan importancia a las implicaciones de salud que pueden experimentara causa de los mismos. Es necesario monitorear la postcomercialización de estosproductos, 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 implementarsistemas para llevarla a cabo. Esta revisión sistemática encontró un limitado númerode publicaciones que informen del estado actual y de las tendencias de la cosmetovigilancia, aunque fue posible definir el concepto e identificar los paísesque 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.

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Patch testing with own cosmetics—a prospective study of testing and reporting of adverse effects to the Swedish Medical Products Agency

Abstract: For a substantial number of patients, their own cosmetics were suspected of causing adverse reactions and were therefore tested. During the study, the number of reports to the MPA tripled, and the relevant products were easier to identify.

Cited by 13 publications

References 15 publications

Analysis and Reporting of Adverse Drug Reactions of Cosmetics at a Tertiary Care Hospital

Analysis and Reporting of Adverse Drug Reactions of Cosmetics at a Tertiary Care Hospital

Surveillance of dermo-cosmetic products: a global cosmetovigilance system to optimise product development and consumer safety

Cosmetovigilancia: un estudio de alcance

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