Repeated or Continuous Medically Supervised Ketamine Administration Associated with Hepatobiliary Adverse Events:...

Area of Science:

• Pharmacology
• Hepatology
• Clinical Medicine

Background:

• Off-label ketamine use for chronic conditions like depression and pain necessitates repeated administration.
• International reports suggest potential risks, including hepatobiliary damage, with long-term ketamine exposure.

Purpose of the Study:

• To investigate the association between repeated ketamine administration and hepatobiliary events.
• To analyze trends in ketamine utilization across various clinical settings.

Main Methods:

• Retrospective case series analysis using FDA Adverse Event Reporting System and medical literature.
• Included cases of repeated ketamine exposure and hepatobiliary events (excluding abuse); analyzed patient demographics, administration route, dose, onset, event type, and risk factors.
• Assessed ketamine sales trends (2013-2017) using IQVIA National Sales Perspectives™.

Main Results:

• Identified 14 cases with 21 hepatobiliary adverse events, including universal liver enzyme elevation, and specific instances of liver cirrhosis, cholangitis, and fibrosis.
• Most cases involved ketamine for complex regional pain syndrome or chronic pain; events often occurred within 4 days.
• Nationally, ketamine vial sales increased from 1.2 million (2013) to 2.1 million (2017).

Conclusions:

• A link exists between repeated ketamine administration and hepatobiliary adverse events.
• Enhanced clinician awareness is recommended to mitigate risks associated with increasing ketamine sales and use.