Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

Abstract

Background: Skin is the most common organ involved in adverse reactions due to drugs. With newer drugs released into market every year, there is changing pattern of the reported cutaneous adverse drug reactions (ADRs). In order to ensure safer use of medicines in patients, there is need for continuous monitoring of ADRs. This is a retrospective study to analyse spontaneously reported cutaneous ADRs.Methods: All the cutaneous ADRs reported between January 2017 and September 2018 were analysed for clinical patterns, suspected medications, causality, severity and preventability.Results: Of the 1035 reports received during the study period, 232 (22.41%) included cutaneous reactions. 113 (48.7%) were male and 119 (51.29%) were female. Maculopapular rash 70 (30.17%), pruritus 31 (13.36%), palmar plantar erythrodysesthesia 30 (12.93%), acne 19 (8.19%), urticaria 16 (6.89%) and fixed drug eruptions (FDE) 13 (5.6%) were the common clinical patterns. Antimicrobial agents followed by anticancer drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), hormones and related drugs, and antiepileptic drugs were the common suspected group of drugs. Causality assessment as done by WHO-UMC scale showed that 3 (1.29%) were certainly related, 174 (75%) were probably related and 55 (23.7%) were possibly related to the suspected medication.Conclusions: Cutaneous ADRs are most frequently reported ADRs in the present study. With newer drugs released into market, there is a need for continuous monitoring of use of drugs to promote safer use of medicines in patients.

Spectrum of cutaneous adverse drug reactions reported at a tertiary health care center

“…(11) Most of maculopapular eruptions in our study were caused by antimicrobial agents followed by NSAIDS and antiepileptic and sedative drugs, study by Konda et al was similar to our study. (2) However in few studies by Noel et al & Chatterjee et al antiepileptic agents were responsible for majority of maculopapular eruptions reported. (12,13)There were 15(13.88%) cases of acne reported in our current study ,most of the cases were attributed to corticosteroids followed by antitubercular drugs and antimicrobials (especially tetracyclines),Antipsychotic drugs, antitubercular drugs and corticosteroids are responsible for acneiform eruptions in majority of reported adverse drug reactions.…”

“…Cutaneous adverse drug reactions are any non desirable alteration in skin integrity, structure and function of the skin or its mucous membrane or its appendages comprising of drugs causing it. (2) Cutaneous adverse drug reactions are known by the name toxidermia (skin manifestations arising from different drug administration)(3) Cutaneous adverse drug reactions can have wide morphological and clinical presentations ranging from maculopapular rash to severe epidermal necrolysis involving multiple organs. (4) Common cutaneous ADR's oftenly reported in opd are skin rash, angioedema, fixed drug eruption, contact dermatitis etc.…”