Science to Practice
Latest highlights on drug safety and efficacy

26.9.2025

Idiosyncratic drug-induced liver injury (DILI), though uncommon, remains the leading cause of drug withdrawals from the market and the second most common cause of acute liver failure (following paracetamol overdose). Despite its clinical significance, DILI risk is still frequently overlooked at the time of drug initiation and is rarely evaluated on a compound-specific level. 

The U.S. DILI Network (DILIN) has helped to quantify individual drug risk by estimating real-world DILI incidences (1). In their prospective cohort study, azathioprine showed the highest estimated incidence – approximately 1 in 350 prescriptions – underscoring the need for improved safety stratification in commonly used drugs (1). Other well-documented agents include amoxicillin-clavulanate, isoniazid, diclofenac, and flucloxacillin, all of which demonstrate variability in both injury pattern and clinical presentation. Additionally, older antiepileptic drugs were a major contributor to hepatotoxicity risk. Notably valproic acid, phenytoin, carbamazepine, lamotrigine and phenobarbital (1).  

Not all drugs carry the same liver risk. Drug-induced liver injury (DILI) is the leading cause of drug withdrawals – yet safety assessments still generalise across classes. A tailored, compound-specific approach is essential for safer prescribing and regulatory alignment.

Despite clear evidence of inter-compound differences, many prescribing practices and safety communications still generalize DILI risk across drug classes. A more tailored approach – one that incorporates relevant pharmacologic properties, and real-world incidence – is essential for safer prescribing and better regulatory alignment. 

For more comprehensive information, explore Heparbase, our specialised database providing detailed insights on drug safety and efficacy when treating patients with hepatic impairment.

News produced by Medbase Medical Team

References

1. Chen VL, Rockey DC, Bjornsson ES, Barnhart H, Hoofnagle JH, for the Drug-Induced Liver Injury Network Investigators. Incidence of Idiosyncratic DrugInduced Liver Injury Caused by Prescription Drugs. Drug Saf. 2025;48(2):151–160. PMID: 39317916. doi:10.1007/s40264-024-01486-6