Analysis and Reporting of Adverse Drug Reactions of Cosmetics at a Tertiary Care Hospital

Abstract

Background and objectives Cosmetovigilance is a term used for the activities related to the collection, evaluation, and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. It is now considered a part of the public health system to determine the toxicity of cosmetic products. India has a pharmacovigilance system that monitors adverse drug reactions. Adverse effects due to the use of cosmetic products are undernumbered and a rigorous vigilant system is necessary to check the unmet needs of our country. Hence keeping the above in view, the study was conducted. Material and methods Patients of any gender, aged above 18 years, reporting adverse reactions to cosmetics at the study site were included in the study. The adverse reactions to cosmetics were noted. The causality of the observed adverse cosmetic reactions (ACRs) was done by the European Cosmetic, Toiletry and Perfumery Association (COLIPA) and Product Lifecycle Management (PLM) methods. Results A total of 120 patients were included in the study. The cosmetic products used by the patients were mainly face care products (n=144) followed by make-up care products (n=126). A total of 121 types of ACRs were reported. The majority of the ACRs were caused by products involved in facial care (62; 51.2%) followed by personal care products (20; 16.5%). In the causality assessment of the ACRs using the COLIPA method, 49.4% of patients were categorized as likely, and using the PLM method, 59% of the events were categorized as probable. Conclusion Most of the ACRs were caused by face care products and acne was reported as the most frequently occurring ACR. Awareness programs regarding the reporting of ACRs should be encouraged among cosmetic users and stakeholders.