Spontaneous reporting of drug-related hepatic reactions from two Italian Regions [Lombardy and Veneto]

Background and aims. Many currently used drugs are implicated in liver diso rders ranging from asymptomatic abnormal liver function tests to fatal live r failure, and drug-induced hepatic reactions are the most frequent cause o f the withdrawal of drugs from the market in the United States, United King dom and Spain. The aim of this study was to review the drug-induced hepatic reactions notified to the spontaneous surveillance system of two Italian r egions (Lombardy and the Veneto) up to 31 December 1998. Patients and methods. The reports of hepatic adverse drug reactions were ex tracted from an inter-regional database of spontaneous adverse drug reactio n reports and analysed by reporter category, patient age and sex, the under lying disease, the adverse reaction and drug exposure. In the case of drugs involved in more than four reports, a search was made of the Medline, Hepa tox, Micromedex and WHO databases. Results. Between 1988 and 1998, there were 310 reports of hepatic lesions a ssociated with single drugs or fixed combinations, the most frequently invo lved patient categories being females and the elderly Sixty percent of the reactions were classified as serious, with three fatal cases. Thirteen drug s were associated with more than four reports and accounted for 35% of all of the hepatic reactions. Six drugs not known as hepatotoxic agents were as sociated with hepatic reactions. Conclusions. In this study spontaneous reports have suggested previously un known hepatotoxicty of six drugs, and have improved drug safety profiles as shown in an Italian inter-regional health service.