Prevalence of Cutaneous Adverse Drug Reactions According to Iraqi Pharmacovigilance Center; A retrospective study for 11 years (2010-2021)

Abstract

Background: Cutaneous Adverse Drug Reactions (CADRs) are among the leading causes of morbidity and mortality. Insufficient data exists on cutaneous adverse reactions, as many of these reactions are not reported due to their constantly changing patterns and the interaction of multiple risk factors. Aim: This study aims to evaluate the prevalence of cutaneous reactions in Iraq and find the most commonly involved active ingredients with the commonest skin manifestations. Method: A retrospective study based on the safety reports of patients having cutaneous reactions that were collected and submitted to VigiBase by the Iraqi Pharmacovigilance Center between 2010 and 2021. The study involved the analysis of gender, age, medicines, type of CADR, and seriousness of more than 4,300 reports. Results: Skin rash was the most commonly reported CADR, and antibiotics were the leading drug class; ceftriaxone and vancomycin were responsible for 40.3% and 16.2% of the cases caused by antibiotics only, respectively. The mean age of the patients was 28 years, and the male-to-female ratio was 0.78:1. Out of the total number of cases, more than 1300 were deemed serious, and 15 patients have passed away. Conclusion: Iraq comes in the 51st place among other countries in the number of skin and skin-related ADR cases. Older adults are at higher risk of developing serious CADRs. Ceftriaxone and rash were the leading drug and cutaneous manifestations, respectively.

Keywords

• cutaneous adverse drug reactions
• Iraqi pharmacovigilance center
• VigiBase
• VigiLyze