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基于沙特食品药品管理局的化妆品警戒数据评估沙特阿拉伯化妆品的报告趋势及不良反应。

Evaluating reporting trends and adverse effects of cosmetic products in Saudi Arabia based on SFDA cosmovigilance data.

作者信息

Aljallal Mohammed A, Alhumaid Mishal I, Alkathiri Fai A

机构信息

Saudi Food and Drug Authority, Riyadh, Saudi Arabia.

Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.

出版信息

Sci Rep. 2025 Jul 22;15(1):26605. doi: 10.1038/s41598-025-08739-z.

Abstract

This retrospective observational study aimed to assess category-specific side effect reporting trends for cosmetic products in the Saudi Arabian market. A total of 1714 reports were analyzed from the Saudi Food and Drug Authority's (SFDA) Cosmovigilance Database over a four-year period (2020-2023). The analysis showed that 53.32% of reports were submitted by males consumer. Phone-based reporting was the most common method (51.16%), followed by submissions through the official vigilance system (45.80%). Reporting activity increased steadily over the years, reflecting enhanced consumer awareness and engagement. Skincare products were the most frequently implicated category, with sensitivity (12.00%) and redness (4.00%) being the top reported adverse effects. Violations were primarily associated with heavy metals and bacterial contamination. The study emphasizes the vital role of the SFDA's cosmovigilance system in maintaining public health and supports continued efforts to promote safe cosmetic.

摘要

这项回顾性观察研究旨在评估沙特阿拉伯市场上化妆品特定类别的副作用报告趋势。在四年期间(2020 - 2023年),对沙特食品药品管理局(SFDA)的化妆品警戒数据库中的1714份报告进行了分析。分析表明,53.32%的报告由男性消费者提交。基于电话的报告是最常见的方式(51.16%),其次是通过官方警戒系统提交(45.80%)。多年来报告活动稳步增加,反映出消费者意识和参与度的提高。护肤品是最常涉及的类别,敏感性(12.00%)和发红(4.00%)是报告最多的不良反应。违规行为主要与重金属和细菌污染有关。该研究强调了SFDA化妆品警戒系统在维护公众健康方面的重要作用,并支持为促进安全化妆品而持续做出的努力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2083/12284188/000fba589830/41598_2025_8739_Fig1_HTML.jpg

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