A prospective study of clinical spectrum of cutaneous adverse drug reactions and their incidence in Indian population

Abstract

Making the diagnosis of a drug-induced reaction requires familiarity with the clinical patterns as the current understanding of the disease processes is not enough to explain about apparently similar pathological mechanisms generating different clinical patterns. Therefore, it remains useful and relevant to overlay a pathological understanding with a clinical classification. This study concentrated on observing and documenting the clinical presentation of cutaneous adverse drug reactions (CADR) encountered in patients. The purpose of the study was to evaluate causality, severity and preventability of Dermatological ADRs.: To study morphological types of CADR and their incidence in Indian population Method: A prospective, observational study was carried out over a period of one year at Out Patient Department of Dermatology, Government Medical College, Amritsar with diagnosed CADRs. The suspected ADRs were evaluated for causality by Naranjo’s Probability scale and severity by Hartwig and Siegel scale.Total 54 patients were enrolled. The incidence of CADR was 0.09%. Most commonly manifested ADR was fixed drug eruption (FDE) i.e. 35.2%. Maximum incidence of dermatological ADRs were observed with antimicrobial agents (39%) followed by non-steroidal anti-inflammatory drugs (NSAIDS) (24%). Naranjo’s Probabilty scale showed most cases of probable (68.5%) ADRs were of moderate severity (90.7%).Awareness about CADR is essential for early detection, management of patients and drug safety. The healthcare system can promote the spontaneous reporting of dermatological ADR to Pharmacovigilance centers for ensuring safe drug usage and patient care.