A strategy to improve the detection of drug-induced hepatotoxicity

Abstract

AIMS: To report a new strategy for the detection of hepatotoxic adverse drug reactions (ADRs) in hospitalized patients improving the results obtained with other methods. DESIGN: The model is based on the identification of a single alert signal in various target clinical departments over a 12-month period. Each patient was later interviewed following a set protocol. The main results analyzed were the drugs suspected of ADR; causal relationship between suspected drugs and ADRs; ADR severity, and incidence of hepatotoxic ADR/100,000 inhabitants. SUBJECTS: Population served by a university-affiliated urban teaching hospital (519,381 inhabitants). RESULTS: The overall ratio of confirmed/suspected ADRs was high (35/80). The most commonly reported drug was amoxicillin-clavulanic acid (4 cases). With regard to causality, 2 suspected cases were classified as definite and 14 as probable. The distribution according to the severity of hepatotoxicity was 6 severe and 29 mild cases. The incidence of hepatotoxic ADRs/100,000 inhabitants as revealed by our method was much higher versus voluntary report (6.74 and 1.79, respectively). CONCLUSIONS: Our method has proven effective for improving the detection of hepatotoxic ADRs, and may be extended to other types of adverse reactions.