Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative

Eric B. Cohen (), Meenal Patwardhan, Ritu Raheja, David H. Alpers, Raul J. Andrade, Mark I. Avigan, James H. Lewis, Don C. Rockey, Francis Chui, Alexandru M. Iacob, Camila C. Linardi, Arie Regev, Jesse Shick and M Isabel Lucena
Additional contact information
Eric B. Cohen: AbbVie Inc.
Meenal Patwardhan: AbbVie Inc.
Ritu Raheja: AbbVie Inc.
David H. Alpers: Washington University School of Medicine
Raul J. Andrade: IBIMA_Plataforma Bionand, University of Malaga
Mark I. Avigan: Food and Drug Administration, Center for Drug Evaluation and Research
James H. Lewis: Georgetown University
Don C. Rockey: Medical University of South Carolina
Francis Chui: Gilead Sciences Inc.
Alexandru M. Iacob: AbbVie Inc.
Camila C. Linardi: Bayer HealthCare Pharmaceuticals LLC
Arie Regev: Eli Lilly and Company
Jesse Shick: Gilead Sciences Inc.
M Isabel Lucena: IBIMA_Plataforma Bionand, University of Malaga

Drug Safety, 2024, vol. 47, issue 4, No 2, 319 pages

Abstract: Abstract The elderly demographic is the fastest-growing segment of the world’s population and is projected to exceed 1.5 billion people by 2050. With multimorbidity, polypharmacy, susceptibility to drug–drug interactions, and frailty as distinct risk factors, elderly patients are especially vulnerable to developing potentially life-threatening safety events such as serious forms of drug-induced liver injury (DILI). It has been a longstanding shortcoming that elderly individuals are often a vulnerable population underrepresented in clinical trials. As such, an improved understanding of DILI in the elderly is a high-priority, unmet need. This challenge is underscored by recent documents put forward by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) that encourage data collection in the elderly and recommend improved practices that will facilitate a more inclusive approach. To establish what is already known about DILI in the elderly and pinpoint key gaps of knowledge in this arena, a working definition of “elderly” is required that accounts for both chronologic and biologic ages and varying states of frailty. In addition, it is critical to characterize the biological role of aging on liver function, as well as the different epidemiological factors such as polypharmacy and inappropriate prescribing that are common practices. While data may not show that elderly people are more susceptible to DILI, DILI due to specific drugs might be more common in this population. Improved characterization of DILI in the elderly may enhance diagnostic and prognostic capabilities and improve the way in which liver safety is monitored during clinical trials. This summary of the published literature provides a framework to understand and evaluate the risk of DILI in the elderly. Consensus statements and recommendations can help to optimize medical care and catalyze collaborations between academic clinicians, drug manufacturers, and regulatory scientists to enable the generation of high-quality research data relevant to the elderly population.

Date: 2024
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DOI: 10.1007/s40264-023-01390-5

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