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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

1.6K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test01:22

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test

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In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess...
171
Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment01:08

Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment

244
Hepatic impairment, characterized by decreased liver function, does not uniformly mandate adjustments in drug dosage. Whether dosage modifications are necessary depends on various factors related to the drug's metabolism and elimination pathways. If a drug is primarily excreted via the kidneys and bypasses significant hepatic processing, if it undergoes minimal metabolic transformation in the liver, or if it is volatile and primarily expelled through the lungs, dose adjustments may not be...
244
Effect of Hepatic Disease on Pharmacokinetics: Active Drug, Metabolite and Fraction of Metabolized Drug01:14

Effect of Hepatic Disease on Pharmacokinetics: Active Drug, Metabolite and Fraction of Metabolized Drug

202
In pharmacotherapy, monitoring drug concentrations is paramount, especially for drugs whose therapeutic effects hinge on both the active compound and its metabolite. Hepatic impairment profoundly influences drug potency by altering liver function. If the drug is more potent than its metabolite, impaired liver function amplifies drug activity due to elevated drug concentration levels. Conversely, if the metabolite holds greater potency, diminished liver function diminishes drug activity by...
202
Effect of Hepatic Disease on Pharmacokinetics: Drug Dosing and Hepatic Blood Flow01:26

Effect of Hepatic Disease on Pharmacokinetics: Drug Dosing and Hepatic Blood Flow

208
Chronic liver disease significantly impacts drug metabolism due to alterations in hepatic blood flow and enzyme accessibility. This disruption affects the body's pharmacokinetics—the movement and processing of drugs within the system. Key enzymes crucial for metabolizing medications become less accessible, changing how drugs are processed and utilized. Furthermore, liver disease influences the synthesis of plasma proteins, such as albumin and globulins, which play critical roles in drug...
208
Hepatic Drug Excretion: Influencing Factors01:16

Hepatic Drug Excretion: Influencing Factors

512
The biliary system of the liver, crucial for bile secretion and drug excretion, comprises intrahepatic bile ducts that merge to form the common hepatic duct. This duct, carrying hepatic bile, combines with the cystic duct, draining the gallbladder and forming the common bile duct, which empties into the duodenum. Bile, produced by hepatic cells lining the bile canaliculi, is composed primarily of water, bile salts, pigments, electrolytes, and lesser amounts of cholesterol and fatty acids. Bile...
512

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Induction of Drug-Induced, Autoimmune Hepatitis in BALB/c Mice for the Study of Its Pathogenic Mechanisms
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Hepatobiliary Adverse Events Linked to Immune Checkpoint Inhibitors: A Real-World Pharmacovigilance Analysis Using

Yuzhu Chen1,2, Yixin Zeng1, Kaisheng Zhang3

  • 1Department of Oncology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.

Thoracic Cancer
|November 17, 2025
PubMed
Summary

Immune checkpoint inhibitors (ICIs) can cause liver injury. PD-L1 inhibitors are linked to severe liver disease, while PD-1 inhibitors are associated with hepatitis, necessitating drug-specific monitoring for safer cancer treatment.

Keywords:
FAERSdisproportionality analysisdrug‐specific riskhepatobiliary toxicityimmune checkpoint inhibitors

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Area of Science:

  • Oncology
  • Hepatology
  • Pharmacovigilance

Background:

  • Immune checkpoint inhibitors (ICIs) are vital cancer therapies but pose risks of significant hepatobiliary toxicity.
  • Previous research on ICI-induced liver injury was limited by small sample sizes and case reports.
  • Understanding specific toxicity profiles and temporal trends is crucial for safe ICI administration.

Purpose of the Study:

  • To evaluate and compare hepatobiliary toxicity associated with different ICIs using a large adverse event database.
  • To identify variations in toxicity risks and temporal patterns among PD-1 and PD-L1 inhibitors.
  • To provide evidence-based guidance for the safer clinical use of ICIs.

Main Methods:

  • Analysis of over 18.6 million FDA Adverse Event Reporting System (FAERS) reports from 2004-2024.
  • Disproportionality analyses (ROR, PRR, EBGM, BCPNN) to detect safety signals for hepatobiliary toxicity.
  • Weibull modeling for AE onset timing and logistic regression for demographic risk factors.

Main Results:

  • PD-L1 inhibitors (Durvalumab, Atezolizumab) showed stronger associations with immune-mediated liver disease and hepatic failure (ROR 4.28-5.07).
  • PD-1 inhibitors (Nivolumab, Pembrolizumab) were more frequently linked to hepatitis and liver abnormalities (ROR 3.42-3.93).
  • Median AE onset varied: 23 days for Toripalimab liver injury versus 84 days for Tislelizumab autoimmune hepatitis.

Conclusions:

  • PD-L1 inhibitors are more strongly associated with severe immune-mediated liver injury and failure.
  • PD-1 inhibitors are more commonly linked to hepatitis and general liver abnormalities.
  • Drug-specific monitoring, particularly within the first three months of treatment, is essential for managing ICI-related hepatotoxicity.