Introduction

Cosmetovigilance is public health surveillance on cosmetic products with a public health objective. Since the radical development in beautifying products in Saudi Arabia, the Saudi Food and Drug Authority takes the responsibility of regulating cosmetic products and issuing guidelines to ensure its safety. Despite this, there exists a lacuna of Re published reports on cosmetics-related adverse reactions in the Saudi population. We aimed to assess self-reported adverse reactions in the general public of the Eastern Province, Saudi Arabia.

Materials and Method

A cross-sectional study was conducted for three months. The questionnaire for data collection was adopted and modified from previous studies for the cosmetic utilization behaviors and adverse reactions.

Results

Among the 425 participants, 50.6% reported that they had at least one adverse reaction in the past two years. Redness of the skin (19%), pimples (15%), and itching (13%) were the commonly reported adverse reactions. The majority of the adverse reactions were reported with hair care (29%) and skincare products (25%). The majority [n = 181 (84.2%)] of the participants with managed the ARs by the cessation of the product use. The univariate analysis found that gender, age, allergic to medications and food, family history of allergy, mixing cosmetics, and frequent switching of cosmetic brands were associated with adverse events. However, the adjusted analysis found that allergic to medication (adjusted OR: 3.9), family history of allergy (adjusted OR: 1.91), and mixing cosmetics (adjusted OR: 1.70) were significantly associated with cosmetics-related adverse reactions.

Conclusion

Cosmetovigilance is a model of safety monitoring of cosmetics. It can be considered as a one of the element in public health activities. Pharmacists should be more vigil on this issue in the near future. To strengthen the findings further, a national wide prevalence study can be conducted prospectively and analyses causality and report to the pharmacovigilanvce system of the country.

中文翻译：

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化妆品不良反应的观察研究：实践美容警戒系统的需要。

介绍

Cosmetovigilance 是针对具有公共卫生目标的化妆品的公共卫生监测。自从沙特阿拉伯美容产品的激进发展以来，沙特食品和药物管理局负责监管化妆品并发布指南以确保其安全。尽管如此，Re 发表的关于沙特人群化妆品相关不良反应的报告仍然存在空白。我们旨在评估沙特阿拉伯东部省公众自我报告的不良反应。

材料和方法

进行了为期三个月的横断面研究。数据收集问卷采用并修改了以往关于化妆品使用行为和不良反应的研究。

结果

在 425 名参与者中，50.6% 的人报告说他们在过去两年中至少有一次不良反应。皮肤发红（19%）、丘疹（15%）和瘙痒（13%）是常见的不良反应。据报道，大多数不良反应与护发（29%）和护肤品（25%）有关。大多数 [n = 181 (84.2%)] 的参与者通过停止使用产品来管理 ARs。单因素分析发现，性别、年龄、对药物和食物过敏、家族过敏史、混合化妆品、频繁更换化妆品品牌与不良事件相关。但调整后分析发现对药物过敏（调整后OR：3.9）、过敏家族史（调整后OR：1.91）、混合化妆品（调整后OR：1.

结论

Cosmetovigilance是化妆品安全监测的一种模式。它可以被认为是公共卫生活动中的一个要素。在不久的将来，药剂师应该对这个问题更加警惕。为了进一步加强调查结果，可以前瞻性地进行全国范围的流行研究并分析因果关系并向该国的药物警戒系统报告。