BACKGROUND

Drug-induced liver injury is one of the main reasons for drug withdrawal, but very little is known about drug-induced liver injury in children.

OBJECTIVES

To identify drugs are potentially associated with reports of suspected liver injury in pediatric population using FDA Adverse Event Reporting System (FAERS) Database.

METHODS

We conducted case by non-case disproportionality analysis to detect the suspected liver injury related adverse drug reactions in the population <18 years old. Using FAERS database, we identified the reports of suspected liver injury as cases from January 2004 to December 2019. Proportional reporting ratio (PRR) was calculated to assess the association between drug and suspected hepatic ADRs. A positive signal was defined as PRR at least two, chi-squared of at least four, and three or more cases. Subgroup analyses were performed in the following age categories: 0–1 month, 0–2, 3–11 and 12–17 years.

RESULTS

Overall, 1,423 (0.01%) out of 7,582,465 ADR records pediatric population concerned hepatic injury. Most of the reported liver injuries concerned children aged 12–17 years. 645 Drugs with reports of suspected liver injury were identified. 23 positive drug–liver injury associations were detected, including antituberculosis drugs (pyrazinamide, ethambutol, isoniazid, amikacin, and rifampin), which are already known.

CONCLUSIONS

Drug-induced liver injury is infrequently reported (only 0.01% of total) as a suspected ADR in children and adolescents. The drugs associated with reported hepatotoxicity (paracetamol, antiepileptic and anti-tuberculosis agents) are known to be hepatotoxic in adults as well, but age related changes in associations were observed. FAERS is useful as a start to plan further drug safety studies in children.