Researchers from the Perelman School of Medicine at the University of Pennsylvania have released new findings that challenge the current way we evaluate the safety of medications on the liver.
Their study, recently published in JAMA Internal Medicine, suggests that the existing method of classifying the liver toxicity of medications might not accurately reflect their true risks.
Traditionally, the potential of a medication to cause liver damage, known as “hepatotoxicity,” is assessed by counting the number of reported cases of acute liver injury (ALI).
However, these counts can be misleading because they do not consider how many people are taking the medication and they often miss unreported cases.
To address these issues, the Penn Medicine researchers turned to real-world healthcare data, examining the rates of liver injury among a population to provide a more accurate picture of a medication’s liver toxicity.
Senior author Vincent Lo Re, MD, MSCE, an associate professor of Medicine and Epidemiology, highlighted the importance of this research.
“Understanding the actual rate of severe liver injury after starting a medication can help us determine which patients need closer monitoring with liver-related lab tests during treatment,” he explained.
The study involved an extensive review of medical records from nearly 8 million people, all patients of the United States Veterans Health Administration from 2000 to 2021.
The records were used to assess the incidence rates of severe liver injury for 194 medications suspected of causing liver damage. The researchers focused on medications that had been linked to liver toxicity in more than four published reports.
Their analysis revealed significant discrepancies in how medications are currently classified for liver risk. For instance, they found 17 medications that had a higher rate of severe liver injury than previously recognized, with more than five incidents per 10,000 person-years.
“Person-years” is a measure that combines the number of people in the study with the amount of time each person is observed. For example, 12 person-years could mean one person studied over 12 years or two people over six years each.
One of the medications identified with underestimated liver risk was metronidazole, an antimicrobial used to treat various infections.
According to traditional assessments, these medications would not have been considered highly toxic to the liver, but the real-world data suggest otherwise.
Conversely, the research also identified medications previously thought to be highly liver-toxic based on case reports that showed very low incidence rates of liver injury in the large population study.
Statin medications, commonly used to treat high cholesterol, fell into this category, showing fewer than one severe liver injury event per 10,000 person-years.
The findings of this study could have significant implications for clinical practice and drug regulation. The more accurate assessment method developed by Lo Re and his team not only provides a clearer picture of medication safety but also supports the need for electronic medical records to include alerts for clinicians.
These alerts would signal when a patient starts on a medication with a known high rate of liver injury, prompting more rigorous monitoring.
Ultimately, this research supports a shift towards a more systematic approach to studying drug-induced liver injury in large populations.
Such an approach could greatly enhance our ability to protect patients from potential harm, ensuring that medications are both safe and effective for their intended use.
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The research findings can be found in JAMA Internal Medicine.
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