Omeprazole-induced hepatotoxicity? A case report

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.
• 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.