title: Cutaneous reactions to drugs. An analysis of spontaneous reports in four Italian regions.
abstract: OBJECTIVE
  Cutaneous manifestations are frequently reported in association with drug use. The aim of this study was to analyse the skin reactions reported to the spontaneous surveillance systems of four Italian regions (Friuli Venezia Giulia, Lombardy, Sicily and the Veneto), and correlate the reports with estimated drug consumption during the same period, paying particular attention to the reactions to antimicrobial agents and nonsteroidal anti-inflammatory drugs (NSAIDs).
  
  
  METHODS
  All of the adverse drug reactions (ADRs) reported spontaneously between January 1996 and December 1997 to the surveillance systems of four Italian regions (a total population of about 20 million people) were analysed by a panel of experts including dermatologists. On the basis of the Critical Term List of the World Health Organization (WHO), the reactions were classified as either serious or nonserious events. Drug consumption was expressed as a daily defined dose (DDD)/1000 inhabitants/day.
  
  
  RESULTS
  A total of 2224 adverse skin reaction reports (44.7% of all of the reported ADRs) were identified, making a reporting rate of about 5.5 per 100 000 inhabitants/year. The female/male ratio was 1.58, and the reporting rate progressively increased with age. The drug categories with the highest number of cutaneous reactions were antimicrobials, followed by NSAIDs, analgesics and radiology contrast media. There was a total of 372 (16.9%) serious reaction reports, the most frequent being angioedema (171 cases), erythema multiforme (68 cases) and photosensitivity (37 cases). Co-trimoxazole, followed by the cephalosporins and fluoroquinolones, were associated with the highest consumption-related reporting rate among the antimicrobials, and aspirin and dipyrone among the NSAIDs and analgesics.
  
  
  CONCLUSIONS
  Spontaneous reports from four Italian regions revealed that the skin was the organ most frequently affected by ADRs. The paper shows the validity of a regional decentralized system in Italy.
authors.affiliation: Department of Dermatology University of Milan, Ospedali Riuniti di Bergamo, Bergamo, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Naldi
authors.forename: A
authors.initials: A
authors.lastname: Conforti
authors.forename: M
authors.initials: M
authors.lastname: Venegoni
authors.forename: M G
authors.initials: MG
authors.lastname: Troncon
authors.forename: A
authors.initials: A
authors.lastname: Caputi
authors.forename: E
authors.initials: E
authors.lastname: Ghiotto
authors.forename: A
authors.initials: A
authors.lastname: Cocci
authors.forename: U
authors.initials: U
authors.lastname: Moretti
authors.forename: G
authors.initials: G
authors.lastname: Velo
authors.forename: R
authors.initials: R
authors.lastname: Leone
mesh_terms: D000900:Anti-Bacterial Agents / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D003875:Drug Eruptions / Q000453:epidemiology*; D004363:Drug Utilization; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D011159:Population Surveillance
chemical_list: D000900:Anti-Bacterial Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal