A strategy to improve the detection of drug-induced hepatotoxicity
Ruiz Montero, A.; Durán Quintana, J.A.; Jiménez Sáenz, M.; Abadín Delgado, J.A.
Revista Espanola de Enfermedades Digestivas Organo Oficial de la Sociedad Espanola de Patologia Digestiva 97(3): 155-160
2005
ISSN/ISBN: 1130-0108 PMID: 15839810 Document Number: 590682
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.