Hepatotoxicity Associated with Labetalol Use: A Case Report with Systematic Review and Disproportionality Analysis...

Area of Science:

• Pharmacology
• Hepatology
• Pregnancy Medicine

Background:

• Labetalol is a first-line antihypertensive for pregnant individuals.
• Rare but severe idiosyncratic hepatotoxicity is a known risk.
• Labetalol shows a disproportionately high reporting signal for liver injury compared to other beta-blockers.

Purpose of the Study:

• To investigate the association between labetalol and drug-induced liver injury (DILI).
• To analyze case reports and adverse event data for labetalol-related hepatotoxicity.
• To highlight the importance of early recognition and management of labetalol-induced liver injury.

Main Methods:

• Systematic review of published case reports (PRISMA-guided) from multiple databases.
• Analysis of the FDA Adverse Event Reporting System (FAERS) data (2020Q1-2025Q1).
• Disproportionality analyses (PRR, ROR, IC025) comparing labetalol to other beta-blockers.

Main Results:

• A fatal case of fulminant hepatocellular injury and acute liver failure after labetalol use.
• Systematic review identified 27 case reports; most patients were female, with one-third pregnant/postpartum.
• FAERS data revealed strong disproportionality signals for DILI and autoimmune hepatitis associated with labetalol.

Conclusions:

• Evidence supports a clinically significant association between labetalol and idiosyncratic hepatotoxicity.
• Hepatotoxicity is consistently hepatocellular, sometimes with autoimmune features.
• Heightened clinical awareness and further research into labetalol-induced liver injury are warranted.