title: Cutaneous adverse drug reaction profile in a tertiary care out patient setting in eastern India.
abstract: BACKGROUND
  Cutaneous adverse drug reactions (CADR) are the most frequent of all manifestations of drug sensitivity and manifest with varied and diverse morphology.
  
  
  OBJECTIVE
  To study the prevalence and clinical spectrum of CADR among patients attending outpatient department (OPD) in a tertiary care hospital.
  
  
  METHODS
  An observational study was undertaken over a 1-year period in dermatology OPD of a tertiary care teaching hospital in Eastern India. Patients presenting with suspected drug-related cutaneous lesions were included if drug identity could be ascertained. Clinical profiling was done. Drug history was recorded in a format specified in Indian National Pharmacovigilance Programme and causality assessment carried out as per World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria.
  
  
  RESULTS
  Commonest CADR in our study was morbilliform eruption (30.18%), followed by fixed drug eruption (24.52%), Stevens-Johnson syndrome (SJS)-Toxic epidermal necrolysis (TEN) and overlap of two (24.50%), exfoliative dermatitis (7.54%), urticaria (5.6%), phototoxic drug reaction (3.8%), pityriasis rosea-like eruptions (1.89%), and severe mucositis (1.80%). Drugs implicated were sulfonamides (17%), fixed-dose combinations of fluoroquinolones with nitroimidazoles (11.30%), analgesics (11.30%), antiepileptics (11.30%), beta-lactam antibiotics (9.40%), fluoroquinolones alone (7.50%), allopurinol (7.50%), and azithromycin (5.70%). Reaction latency varied from 1 to 43 days. Causality assessment was certain and probable for 18.9% and 41.5% of the reactions, respectively, and reactions were serious in 33.96% (95% confidence interval 21.21-46.71%).
  
  
  CONCLUSIONS
  Cutaneous adverse drug reaction profile in this study is similar in many ways to studies conducted earlier in India. Incidence of life-threatening reactions like SJS-TEN was higher compared with studies conducted abroad. Reaction time and lesion patterns are helpful in identifying an offending drug in the setting of multiple drug therapy.
authors.affiliation: Department of Dermatology, Medical College, Kolkata, India.
authors.forename: Abanti
authors.initials: A
authors.lastname: Saha
authors.forename: Nilay Kanti
authors.initials: NK
authors.lastname: Das
authors.forename: Avijit
authors.initials: A
authors.lastname: Hazra
authors.forename: Ramesh Chandra
authors.initials: RC
authors.lastname: Gharami
authors.forename: Satyendra Nath
authors.initials: SN
authors.lastname: Chowdhury
authors.forename: Pijush Kanti
authors.initials: PK
authors.lastname: Datta
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D003875:Drug Eruptions / Q000453:epidemiology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D010045:Outpatients / Q000706:statistics & numerical data; D062606:Tertiary Care Centers / Q000706:statistics & numerical data; D055815:Young Adult