Mota Daniel Marques, Leitão Leonardo Oliveira, Silva Ronald Santos, Fernandes Cássia de Fátima Rangel, Silva Marcus Tolentino
Agência Nacional de Vigilância Sanitária, Brasília, DF, Brazil.
Instituto Nacional de Controle de Qualidade em Saúde, Rio de Janeiro, RJ, Brazil.
Epidemiol Serv Saude. 2025 May 2;34:e20240449. doi: 10.1590/S2237-96222024v34e20240449.en. eCollection 2025.
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.
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).
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).
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.
描述巴西卫生监管局（ANVISA）为减少巴西境内与美发霜相关的眼部不良事件病例而采取的健康监测行动，并验证报告病例与这些行动之间的相关性。
这是一项描述性和相关性研究，基于对2022年3月至2024年3月期间的文件和ANVISA病例报告数据库的分析。采用Spearman相关系数检验ANVISA行动与不良事件病例之间的相关性（p值<0.05）。
与ANVISA行动（n = 172）和报告病例（n = 636）相关的情况可分为三个不同时期。第二个时期（2022年12月至2023年6月）采取的行动数量最多（n = 125；72.7%），与病例报告高峰期（n = 550）相符。在此期间，发布了两次安全警报，并下令对巴西销售的所有美发霜实施预防性禁令，该禁令持续了38天。在第三个时期（2023年7月至2024年3月），美发霜销售取消数量最多（n = 3122；79.3%），毒理学分析表明，六个（30.0%）样本被归类为严重刺激/腐蚀性。行动与报告病例之间存在正相关且很强的相关性，范围从0.53（p值0.006）到0.74（p值<0.001）。
强正相关表明ANVISA的行动对病例报告的增加具有反应性，强化了主动监测和快速干预对控制公共卫生风险的重要性。
