Daniel Marques Mota, Leonardo Oliveira Leitão, Ronald Santos Silva, Cássia de Fátima Rangel Fernandes, Marcus Tolentino Silva
{"title":"缓解巴西发型化妆品眼部不良事件的措施:一项描述性和相关性研究(2022-2024)。","authors":"Daniel Marques Mota, Leonardo Oliveira Leitão, Ronald Santos Silva, Cássia de Fátima Rangel Fernandes, Marcus Tolentino Silva","doi":"10.1590/S2237-96222024v34e20240449.en","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To describe health surveillance actions implemented by the Brazilian Health Regulatory Agency (ANVISA) to mitigate cases of ocular adverse events related to hair styling creams in Brazil and verify correlation between reported cases and these actions.</p><p><strong>Methods: </strong>This is a descriptive and correlational study based on analysis of documents and the ANVISA case reporting database, between March 2022 and March 2024. Spearman's correlation coefficient was used to examine correlation between ANVISA actions and cases of adverse events (p-value<0.05).</p><p><strong>Results: </strong>Three distinct periods were identified in relation to ANVISA actions (n=172) and reported cases (n=636). The second period (December 2022 to June 2023) presented the highest number of actions (n=125; 72.7%), coinciding with the peak of case reports (n=550). During this period, two safety alerts were published and a precautionary ban was ordered on all hair styling creams sold in Brazil, which lasted 38 days. In the third period (July 2023 to March 2024), the highest number of cream marketing cancellations occurred (n=3,122; 79.3%), and toxicology analyses indicated that six (30.0%) samples were classified as severely irritant/corrosive. There was a positive and strong correlation between the actions and the reported cases, ranging from 0.53 (p-value 0.006) to 0.74 (p-value<0.001).</p><p><strong>Conclusion: </strong>The strong positive correlation demonstrates that ANVISA's actions were reactive to the increase in case reports, reinforcing the importance of active surveillance and rapid interventions to control risks to public health.</p>","PeriodicalId":51473,"journal":{"name":"Epidemiologia e Servicos de Saude","volume":"34 ","pages":"e20240449"},"PeriodicalIF":2.5000,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12052321/pdf/","citationCount":"0","resultStr":"{\"title\":\"Actions to mitigate ocular adverse events related to hair styling cosmetics in Brazil: a descriptive and correlational study (2022-2024).\",\"authors\":\"Daniel Marques Mota, Leonardo Oliveira Leitão, Ronald Santos Silva, Cássia de Fátima Rangel Fernandes, Marcus Tolentino Silva\",\"doi\":\"10.1590/S2237-96222024v34e20240449.en\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To describe health surveillance actions implemented by the Brazilian Health Regulatory Agency (ANVISA) to mitigate cases of ocular adverse events related to hair styling creams in Brazil and verify correlation between reported cases and these actions.</p><p><strong>Methods: </strong>This is a descriptive and correlational study based on analysis of documents and the ANVISA case reporting database, between March 2022 and March 2024. Spearman's correlation coefficient was used to examine correlation between ANVISA actions and cases of adverse events (p-value<0.05).</p><p><strong>Results: </strong>Three distinct periods were identified in relation to ANVISA actions (n=172) and reported cases (n=636). The second period (December 2022 to June 2023) presented the highest number of actions (n=125; 72.7%), coinciding with the peak of case reports (n=550). During this period, two safety alerts were published and a precautionary ban was ordered on all hair styling creams sold in Brazil, which lasted 38 days. In the third period (July 2023 to March 2024), the highest number of cream marketing cancellations occurred (n=3,122; 79.3%), and toxicology analyses indicated that six (30.0%) samples were classified as severely irritant/corrosive. There was a positive and strong correlation between the actions and the reported cases, ranging from 0.53 (p-value 0.006) to 0.74 (p-value<0.001).</p><p><strong>Conclusion: </strong>The strong positive correlation demonstrates that ANVISA's actions were reactive to the increase in case reports, reinforcing the importance of active surveillance and rapid interventions to control risks to public health.</p>\",\"PeriodicalId\":51473,\"journal\":{\"name\":\"Epidemiologia e Servicos de Saude\",\"volume\":\"34 \",\"pages\":\"e20240449\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2025-05-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12052321/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Epidemiologia e Servicos de Saude\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1590/S2237-96222024v34e20240449.en\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"Multidisciplinary\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Epidemiologia e Servicos de Saude","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1590/S2237-96222024v34e20240449.en","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"Multidisciplinary","Score":null,"Total":0}
Actions to mitigate ocular adverse events related to hair styling cosmetics in Brazil: a descriptive and correlational study (2022-2024).
Objective: To describe health surveillance actions implemented by the Brazilian Health Regulatory Agency (ANVISA) to mitigate cases of ocular adverse events related to hair styling creams in Brazil and verify correlation between reported cases and these actions.
Methods: This is a descriptive and correlational study based on analysis of documents and the ANVISA case reporting database, between March 2022 and March 2024. Spearman's correlation coefficient was used to examine correlation between ANVISA actions and cases of adverse events (p-value<0.05).
Results: Three distinct periods were identified in relation to ANVISA actions (n=172) and reported cases (n=636). The second period (December 2022 to June 2023) presented the highest number of actions (n=125; 72.7%), coinciding with the peak of case reports (n=550). During this period, two safety alerts were published and a precautionary ban was ordered on all hair styling creams sold in Brazil, which lasted 38 days. In the third period (July 2023 to March 2024), the highest number of cream marketing cancellations occurred (n=3,122; 79.3%), and toxicology analyses indicated that six (30.0%) samples were classified as severely irritant/corrosive. There was a positive and strong correlation between the actions and the reported cases, ranging from 0.53 (p-value 0.006) to 0.74 (p-value<0.001).
Conclusion: The strong positive correlation demonstrates that ANVISA's actions were reactive to the increase in case reports, reinforcing the importance of active surveillance and rapid interventions to control risks to public health.