An observational study on adverse reactions of cosmetics: The need of practice the Cosmetovigilance system

Abstract

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.