BACKGROUND AND AIMS: Many currently used drugs are implicated in liver disorders ranging from asymptomatic abnormal liver function tests to fatal liver failure, and drug-induced hepatic reactions are the most frequent cause of the withdrawal of drugs from the market in the United States, United Kingdom and Spain. The aim of this study was to review the drug-induced hepatic reactions notified to the spontaneous surveillance system of two Italian regions (Lombardy and the Veneto) up to 31 December 1998. PATIENTS AND METHODS: The reports of hepatic adverse drug reactions were extracted from an inter-regional database of spontaneous adverse drug reaction reports and analysed by reporter category, patient age and sex, the underlying 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, Hepatox, Micromedex and WHO databases. RESULTS: Between 1988 and 1998, there were 310 reports of hepatic lesions associated with single drugs or fixed combinations, the most frequently involved patient categories being females and the elderly. Sixty percent of the reactions were classified as serious, with three fatal cases. Thirteen drugs 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 associated with hepatic reactions. CONCLUSIONS: In this study, spontaneous reports have suggested previously unknown hepatotoxicty of six drugs, and have improved drug safety profiles as shown in an Italian inter-regional health service.
BACKGROUND AND AIMS: Many currently used drugs are implicated in liver disorders ranging from asymptomatic abnormal liver function tests to fatal liver failure, and drug-induced hepatic reactions are the most frequent cause of the withdrawal of drugs from the market in the United States, United Kingdom and Spain. The aim of this study was to review the drug-induced hepatic reactions notified to the spontaneous surveillance system of two Italian regions (Lombardy and the Veneto) up to 31 December 1998. PATIENTS AND METHODS: The reports of hepatic adverse drug reactions were extracted from an inter-regional database of spontaneous adverse drug reaction reports and analysed by reporter category, patient age and sex, the underlying 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, Hepatox, Micromedex and WHO databases. RESULTS: Between 1988 and 1998, there were 310 reports of hepatic lesions associated with single drugs or fixed combinations, the most frequently involved patient categories being females and the elderly. Sixty percent of the reactions were classified as serious, with three fatal cases. Thirteen drugs 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 associated with hepatic reactions. CONCLUSIONS: In this study, spontaneous reports have suggested previously unknown hepatotoxicty of six drugs, and have improved drug safety profiles as shown in an Italian inter-regional health service.