Cutaneous Adverse Drug Reactions: Analysis of Reports at the Drugs, Poison Information, and Pharmacovigilance Center (2002 To 2022) at the University of Benin Teaching Hospital
Main Article Content
Abstract
Background: Cutaneous adverse drug reactions are undesirable changes to the skin and subcutaneous tissue. The reporting pattern of these reactions in Nigeria, had hitherto focused on serious reactions, despite the varied presentation. This preliminary report is intended to describe the profile of cutaneous adverse reactions in an established local pharmacovigilance centre.
Methods: The study reviewed all the individual case safety reports of cutaneous adverse drug reactions submitted to the University of Benin Teaching Hospital’s Drugs, Poison Information, and Pharmacovigilance Centre from 2002 to 2022. All reports were analyzed for age, sex, suspected medications, and details of the reaction and dates of the event and medication use. Causality assessment was conducted using the WHO assessment scale. Culprit medicines were classified using the WHO/ATC classification Level II and V.
Results: There were 408(39.1%) cutaneous adverse drug reactions reports found in the database with a mean age of 34.0(21.9%), a female preponderance 260(63.7%). Majority of the reporters were doctors 215(52.7%). These reactions comprised urticaria 68(16.7%), Steven Johnson Syndrome 62(15.2%), rashes 46(11.3%), angioedema 37(9.1%). Serious cutaneous adverse reactions, were reported more 196(48.0%) with 13 fatalities. Culprit medicines classes identified in the study were antimicrobials 222(54.4%), antineoplastics 27(6.6%). The main culprit medicinal products were Nevirapine 46(11.3%), sulphadoxine-pyrimethamine 41(10.0%), sulphamethoxazole-trimethoprim 20(4.9%), Lisinopril 17(4.2%) and artemether-lumenfatrine 16(3.9%).
Conclusion: Cutaneous adverse drug reactions are prevalent and constitute a notable health burden. Prominent drugs causing CADR were antimicrobials, antineoplastic and drugs acting on the renin-angiotensin system. Serious cutaneous ADR, such as SJS, erythema multiforme, and angioedema were significantly reported.