Cutaneous reactions to drugs. An analysis of spontaneous reports in four Italian regions

Aims Cutaneous manifestations are frequently reported in association with d rug use. The aim of this study was to analyse the skin reactions reported t o the spontaneous surveillance systems of four Italian regions (Friuli Vene zia Giulia, Lombardy, Sicily and the Veneto), and correlate the reports wit h estimated drug consumption during the same period, paying particular atte ntion to the reactions to antimicrobial agents and nonsteroidal anti-inflam matory drugs (NSAIDs). Methods All of the adverse drug reactions (ADRs) reported spontaneously bet ween January 1996 and December 1997 to the surveillance systems of four Ita lian regions (a total population of about 20 million people) were analysed by a panel of experts including dermatologists. On the basis of the Critica l Term List of the World Health Organization (WHO), the reactions were clas sified as either serious or nonserious events. Drug consumption was express ed 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 10 0 000 inhabitants/year. The female/male ratio was 1.58, and the reporting r ate progressively increased with age. The drug categories with the highest number of cutaneous reactions were antimicrobials, followed by NSAIDs, anal gesics and radiology contrast media. There was a total of 372 (16.9%) serio us reaction reports, the most frequent being angioedema (171 cases), erythe ma multiforme (68 cases) and photosensitivity (37 cases). Co-trimoxazole, f ollowed by the cephalosporins and fluoroquinolones, were associated with th e 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 v alidity of a regional decentralized system in Italy.