Abstract
Drug-induced liver injury (DILI) is the leading cause of liver failure in the United States and the most common cause of drug recall. As opposed to the recognized direct toxicity of super-therapeutic acetaminophen or chemotherapeutic agents in children, limited data exists for pediatric populations on the incidence of idiosyncratic DILI (iDILI) that may develop independently of drug dose or duration of administration. To improve the detection of adverse drug reactions at our hospital, we utilized electronic medical records-based automated trigger tools to alert providers of potential iDILI. Clinical criteria concerning for iDILI were defined as serum ALT > 5x or serum bilirubin > 1.5x upper limit of normal in the setting of medication exposure. Over a two year period, 12 patients were identified as having possible or probable iDILI. Out of the identified patients, three were males, and the mean age was 10.8 years. Implicated agents included eight antibiotics, two anti-epileptics, one anti-psychotic, and one anti-inflammatory medication. Roussel-Uclaf Causality Assessment Methods identified one “possible” case, 11 “probable” cases, and one “highly probable” case of iDILI. Improved awareness and more vigilant programming can generate better data on iDILI and improve our understanding of the condition and its incidence in children.
Highlights
Drug-induced liver injury (DILI) is the leading cause of liver failure in the United States and the most common cause of drug recall
When chemotherapy ALT triggers were excluded, possible or probable idiosyncratic DILI (iDILI) rose to 3.4%
No cases of iDILI were associated with an isolated bilirubin trigger as all patients had an elevated ALT
Summary
Drug-induced liver injury (DILI) is the leading cause of liver failure in the United States and the most common cause of drug recall. As opposed to the recognized direct toxicity of super-therapeutic acetaminophen or chemotherapeutic agents in children, limited data exists for pediatric populations on the incidence of idiosyncratic DILI (iDILI) that may develop independently of drug dose or duration of administration. Drug-induced liver injury (DILI) is the leading cause of acute liver failure in the United States[1] and the most common cause of drug recall from the market[2]. In an analysis by Mindikoglu and colleagues of 73,977 patients (adults and children) that underwent transplant from October of 1987 to December of 2006, they identified 661 cases of drug-induced acute liver failure. The goal of the program is to identify and improve documentation of potential adverse drug reaction cases, and in turn, better understand medications associated with toxicity and possible preventive strategies. We assess two years of cases associated with pediatric iDILI and report on the implicated agents as well as associated clinical and laboratory characteristics in our population
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