Acciones para mitigar los eventos adversos oculares relacionados con los cosméticos para el cabello en Brasil: estudio descriptivo y correlacional (2022-2024)

Mota, Daniel Marques; Leitão, Leonardo Oliveira; Silva, Ronald Santos; Fernandes, Cássia de Fátima Rangel; Silva, Marcus Tolentino

doi:10.1590/S2237-96222024v34e20240449.en

Sumário Anterior Atual Seguinte

Sumário

ORIGINAL ARTICLE • Epidemiol. Serv. Saúde 34 • 2025 • https://doi.org/10.1590/S2237-96222024v34e20240449.en linkcopiar

Este documento está relacionado con:

10.1590/S2237-96222024v34e20240449.a

Este documento está relacionado con:

10.1590/S2237-96222024v34e20240449.b

Este documento está relacionado con:

10.1590/S2237-96222024v34e20240449.c

Acciones para mitigar los eventos adversos oculares relacionados con los cosméticos para el cabello en Brasil: estudio descriptivo y correlacional (2022-2024)

Autoría SCIMAGO INSTITUTIONS RANKINGS

Objetivo Describir las acciones de vigilancia en salud implementadas por la Agencia Nacional de Vigilancia Sanitaria (ANVISA) para mitigar los casos de eventos adversos oculares relacionados con cremas para peinar el cabello en Brasil y verificar la correlación entre los casos notificados y esas acciones.

Métodos Estudio descriptivo y correlacional, basado en el análisis de documentos y de la base de datos de notificaciones de ANVISA, entre marzo de 2022 y marzo de 2024. Se utilizó el coeficiente de correlación de Spearman para examinar la correlación entre las acciones de ANVISA y los casos de eventos adversos (valor p<0,05).

Resultados Se identificaron tres períodos distintos en relación a las acciones de ANVISA (n=172) y a los casos notificados (n=636). El segundo período (diciembre de 2022 a junio de 2023) presentó el mayor número de acciones (n=125; 72,7%), coincidiendo con el pico de notificaciones de casos (n=550). Durante este período se publicaron dos alertas de seguridad y se ordenó una prohibición cautelar de todas las cremas para peinar el cabello comercializadas en el país, la cual duró 38 días. En el tercer período (julio de 2023 a marzo de 2024), se produjo el mayor número de cancelaciones de comercialización de cremas (n=3.122; 79,3%), y los análisis toxicológicos indicaron que seis (30,0%) muestras fueron clasificadas como irritantes/corrosivas severas. Hubo una correlación positiva y fuerte entre las acciones y los casos reportados, que oscilaron entre 0,53 (valor p 0,006) y 0,74 (valor p<0,001).

Conclusión La fuerte correlación positiva demuestra que las acciones de ANVISA fueron reactivas al aumento de las notificaciones de casos, reforzando la importancia de la vigilancia activa y de las intervenciones rápidas para controlar los riesgos para la salud pública.

Palabras clave
Preparaciones para el Cabello; Lesiones de la Cornea; Vigilancia de Productos Comercializados; Análisis de Documentos; Correlación de Datos

Data source	Type of document	Keywords	Selection filters	Internet URL
Official Gazette of the Union	Normative acts	Cera fixadora Cera modeladora Gel cera Gel cola Intoxicação ocular Pasta fixadora Pasta modeladora Pomada capilar Pomada fixadora Pomada modeladora Pomade Pomadas para trançar	Search type: exact result Where to search: in content Search method: act by act Gazette: Section 1 and Extra and supplementary edition	https://www.in.gov.br/leiturajornal
Internet portal of the Brazilian Health Regulatory Agency Portal (Agência Nacional de Vigilância Sanitária - ANVISA)	Alerts	Not applicable	Cosmetic subjects	https://antigo.anvisa.gov.br/alertas
	Data spreadsheet	Not applicable	Not applicable	https://www.gov.br/anvisa/pt-br/assuntos/cosmeticos/pomadas/pomadas-autorizadas
	News	Pomad Modela Trança	Category: Health and Sanitary Surveillance	https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa
ANVISA electronic information system	Reports, bulletins, technical notes, letters, dispatches, memos and emails	Not applicable	Not applicable	Not applicable

Data	Sanitary surveillance action	Thematic category
December 13, 2022 to January 19, 2023	ANVISA published two safety alerts: Alert No. 07/2022, about temporary blindness and other undesirable effects, supposedly caused by hair styling creams; and Alert No. 01/2023, which updated this information.	Cosmetovigilance action
December 14, 2022 to June 19, 2023	Seventeen news articles published on ANVISA’s internet portal, corresponding to 65.4% of the total news items published in the 25-month period (n=26).	Marketing authorization, cosmetovigilância, market inspection and laboratory analysis action
January 6 to June 27, 2023	ANVISA published 66 normative acts, representing 68.7% of the total during the study period (n=96). Of these, 36 were inspection measures, with the majority (69.4%) involving the suspension and recall of hair styling creams, and 30 marketing authorizations, with 86.7% referring to the cancellation of these products. Between December 2022 and June 2023, 809 styling creams had their authorizations canceled.	Inspection and marketing authorization action
January 18, 2023	Consultation restricted to the ANVISA Sentinel Hospital Network. The objective of the action was to capture records of care provided to patients with eye problems related to the use of hair styling creams in health units throughout 2022.	Cosmetovigilance action
February 4 to March 27, 2023	Field investigation carried out at the Souza Aguiar Municipal Hospital in Rio de Janeiro, with preliminary data from the second week of research conducted by the Training Program on Epidemiology Applied to the Services of the Brazilian Ministry of Health National Health System. A total of 451 patients had been treated at the health unit with ocular adverse events related to styling creams, between December 19, 2022 and January 31, 2023. Other field investigations took place in the municipality of Humaitá (Amazonas) and in the state of Pernambuco.	Cosmetovigilance action
February 10, 2023	ANVISA banned all hair styling creams, prohibiting their marketing in Brazil, through Resolution No. 475, dated February 9, 2023, due to reports of serious adverse events. This standard is part of the 66 normative acts mentioned above.	Market inspection action
February 10 to October 27, 2023	Six laboratory analysis reports were produced, including results of nuclear magnetic resonance, infrared spectrometry, physical-chemical analyses, chemical analyses, microbiological analyses and toxicological assessment of ocular irritation and corrosion due to hair styling creams. These reports were prepared by public institutions that work in partnership with ANVISA.	Laboratory analysis action
February 8 to March 23, 2023	Consultations and responses from international health authorities from ten countries plus the European Union on the occurrence of ocular adverse events related to hair styling creams. All those health authorities replied that they had had no similar cases.	Cosmetovigilance action
March 16 to April 26, 2023	Two cosmetovigilance bulletins were made available for internal consultation by ANVISA. The two documents presented, in particular, an epidemiological analysis of cases of ocular adverse events related to styling creams, in terms of time, place and person.	Cosmetovigilance action
March 20, 2023	ANVISA authorized marketing of a restricted list of hair styling creams. In the last update of this list, carried out on February 9, 2024, there were 490 hair styling creams that could be sold in Brazil.	Market inspection action and marketing authorization action

Variables	Spearman’s coefficient	p-value
Actions as a whole and number of reports of ocular adverse events	0.74	<0.001
Marketing authorization actions and number of reports of ocular adverse events	0.64	<0.001
Market inspection actions and number of reports of ocular adverse events	0.59	0.002
Cosmetovigilance actions and number of reports of ocular adverse events	0.57	0.003
Laboratory analysis actions and number of reports of ocular adverse events	0.53	0.006

location_on

Secretaria de Vigilância em Saúde e Ambiente - Ministério da Saúde do Brasil SRTVN Quadra 701, Via W5 Norte, Lote D, Edifício P0700, CEP: 70719-040, +55 (61) 3315-3464 - Brasília - DF - Brazil
E-mail: ress.svs@gmail.com

rss_feed Acompanhe os números deste periódico no seu leitor de RSS