Hepatitis associated with amoxycillin-clavulanic acid combination report of 15 cases

D Larrey1, T Vial, A Micaleff

  • 1Service des Maladies de l'Appareil Digestif, Hôpital Saint-Eloi, Montpellier, France.

Gut
|March 1, 1992
PubMed

Insights

Hepatitis linked to amoxicillin-clavulanic acid is rare, affecting mostly older men. Symptoms appear weeks after treatment, but recovery is typical within months, suggesting a low overall risk.

Area of Science:

  • Hepatology
  • Clinical Pharmacology
  • Drug-Induced Liver Injury

Background:

  • Amoxicillin-clavulanic acid is a widely used antibiotic combination.
  • Drug-induced liver injury (DILI) is a significant concern in clinical practice.
  • Hepatitis associated with antibiotic use requires careful monitoring and characterization.

Purpose of the Study:

  • To report and characterize cases of hepatitis associated with amoxicillin-clavulanic acid.
  • To investigate the clinical presentation, laboratory findings, and outcomes of this specific drug-induced hepatitis.
  • To estimate the incidence and identify potential risk factors for amoxicillin-clavulanic acid-induced hepatitis.

Main Methods:

  • Retrospective case series analysis of fifteen patients diagnosed with hepatitis.
  • Review of clinical data, including patient demographics, treatment details, symptoms, laboratory results (liver enzymes), and liver histology.
  • Estimation of the incidence of hepatitis based on reported cases and estimated drug usage.

Main Results:

  • Fifteen cases of hepatitis were identified, predominantly in men over 60 years old.
  • Hepatitis symptoms, including jaundice and pruritus, often appeared 1-4 weeks after treatment cessation.
  • Elevated aminotransferases and alkaline phosphatase were consistent findings; liver histology showed cholestasis. Recovery was generally complete within 4-16 weeks.
  • The estimated risk of hepatitis was very low (below 1/100,000), but potentially higher in elderly men with prolonged treatment.

Conclusions:

  • Amoxicillin-clavulanic acid can cause hepatitis, characterized by cholestasis and a generally good prognosis.
  • Elderly men receiving prolonged treatment may be at increased risk.
  • The findings suggest a possible immunoallergic mechanism in some cases of drug-induced hepatitis.

Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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...
Combined Effects of Drugs: Synergism01:27

Combined Effects of Drugs: Synergism

Synergism is a useful mechanism where combining two or more drugs is more effective than each constituent used alone. Such combinations are also called supra-additive interactions. The drugs collectively enhance the final therapeutic effect by acting on different targets. Another advantage is that the low dose of each constituent drug is sufficient to achieve the desired effect. This helps reduce the duration of therapy and lower the adverse effects of these drugs.
Such synergistic combinations...
Acute Pharyngitis01:30

Acute Pharyngitis

Introduction
Acute pharyngitis is the inflammation of the back of the throat (pharynx), commonly resulting in a sore throat. It is a frequently encountered condition that prompts individuals to seek medical advice.
Classification
Acute pharyngitis can be categorized based on its underlying cause:
Drug Toxicity: Allergic Reactions01:30

Drug Toxicity: Allergic Reactions

Drug-related allergies are immune-mediated responses triggered by the administration of pharmacological agents. These hypersensitivity reactions are classified based on the immune mechanisms involved. The four primary types—Type I, II, III, and IV—are mediated by different immunological pathways and exhibit distinct clinical manifestations.Type I Hypersensitivity/ IgE-Mediated Reactions: Immunoglobulin E (IgE) immediately mediates Type I hypersensitivity reactions. Upon initial exposure to a...
Hepatitis01:25

Hepatitis

Hepatitis is an inflammatory condition of the liver most commonly caused by hepatotropic viruses (A–E), though non-infectious causes such as alcohol and drugs also exist.Hepatitis AHepatitis A virus (HAV) is a non-enveloped RNA virus of the Picornaviridae family. It is primarily transmitted via the fecal-oral route, typically through ingestion of contaminated food or water. After ingestion, HAV enters the bloodstream through the oropharynx or intestinal epithelium and reaches the liver. The...
Cholecystitis01:20

Cholecystitis

Cholecystitis is inflammation of the gallbladder, most commonly caused by obstruction of the cystic duct. This blockage prevents bile from draining, leading to gallbladder distension, inflammation, and potentially serious complications. This condition may present acutely or chronically and can happen with or without gallstones.EtiologyAbout 95% of cholecystitis cases are calculous, caused by gallstones blocking the cystic duct, leading to bile accumulation and inflammation of the gallbladder...