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Related Experiment Videos

Omeprazole-induced hepatotoxicity? A case report.

C Christe1, R Stoller, N Vogt

  • 1Gerontopharmacology Unit, Hôpital de Gériatrie, CH-1226 Geneva, Switzerland. christe-caroline@diogenes.hcuge.ch

Pharmacoepidemiology and Drug Safety
|April 10, 2004
PubMed
Summary

Omeprazole, a common medication, can rarely cause severe liver injury (hepatotoxicity). This case report highlights a patient who experienced liver damage after long-term omeprazole use, emphasizing the need for vigilance.

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Area of Science:

  • Hepatology
  • Pharmacovigilance
  • Internal Medicine

Background:

  • Proton pump inhibitors like omeprazole are widely used for acid-related gastrointestinal disorders.
  • While generally safe, rare adverse drug reactions (ADRs) can occur, necessitating ongoing monitoring.
  • Hepatotoxicity is a potential, albeit uncommon, side effect associated with various medications.

Purpose of the Study:

  • To report a case of severe symptomatic hepatocellular liver injury potentially induced by long-term omeprazole use.
  • To contribute to the understanding of rare adverse drug reactions associated with omeprazole.
  • To underscore the importance of considering drug-induced liver injury in patients presenting with unexplained hepatitis.

Main Methods:

  • A case report of an 85-year-old male patient with a history of ischemic heart disease.

Related Experiment Videos

  • Detailed observation of liver enzyme levels (AST, ALT, AP) before, during, and after omeprazole treatment and re-challenge.
  • Review of existing literature and drug regulatory agency databases for reported cases of omeprazole-induced liver injury.

    • Main Results:

    • The patient developed severe symptomatic hepatocellular liver injury with significantly elevated liver enzymes during long-term omeprazole therapy.
    • Discontinuation of omeprazole led to normalization of liver enzymes within 12 days.
    • Re-exposure to omeprazole resulted in a recurrence of elevated liver enzymes, further supporting a causal link.
    • While clinical studies report minimal liver enzyme elevations in 1-5% of cases, this case demonstrates severe hepatotoxicity.

    Conclusions:

    • Hepatitis is a rare but possible complication of omeprazole treatment, as suggested by this case and international reports.
    • The Swiss Drug Regulatory Agency and WHO Data Base have documented cases of omeprazole-associated liver injury, including cholestatic hepatitis and hepatic failure.
    • This case emphasizes the importance of considering omeprazole as a potential cause of severe liver injury, especially with prolonged use or in susceptible individuals.