Hepatotoxicity associated with statins: Reports of idiosyncratic liver injury post-marketing

Einar Björnsson*, Elin I. Jacobsen, Evangelos Kalaitzakis

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

200 Citations (Scopus)


Background & Aims: Limited data exist on drug-induced liver injury (DILI) associated with statins. Methods: Reports on adverse reactions suspected to be due to statins received by the Swedish Adverse Drug Reactions Advisory Committe 1988-2010 were analyzed. Only cases with >5 × upper limit of normal (ULN) in aminotransferases and/or alkaline phosphatase >2 × ULN were included. Results: The most common types of ADRs suspected were DILI in 124/217 (57%) cases. A total of 73/124 (59%) cases had at least possible relationship, median age 64 years (57-73), 55% males, whereas 25/124 cases (20%) were excluded due to mild elevations of liver tests and 26 due to unlikely relationship and/or lack of data. A statin-related DILI episode was reported in 1.2/100,000 users. Atorvastatin was implicated in 30/73 (41%) cases, simvastatin in 28 (38%), fluvastatin (15%), and others. Two patients died of acute liver failure, one underwent liver transplantation and 25 (34%) had jaundice. Three patients were rechallenged with the same statin producing similar patterns of liver injury. The median duration of therapy was 90 days (30-120), 120 (39-248) for atorvastatin, and 75 (30-150) for simvastatin (NS). Cholestatic/mixed injury was more common with atorvastatin, 17/30 (56%) than with simvastatin, 7/28 (24%) (p = 0.018). Conclusions: Idiosyncratic liver injury associated with statins is rare but can be severe. After recovery, a similar pattern of liver injury can be reproduced on re-exposure. Most patients experience liver injury 3-4 months after start of therapy. Atorvastatin is mostly associated with cholestatic liver injury whereas hepatocellular injury is more common with simvastatin.

Original languageEnglish
Pages (from-to)374-380
Number of pages7
JournalJournal of Hepatology
Issue number2
Publication statusPublished - Feb 2012

Other keywords

  • Drug-induced liver injury
  • Hepatoxicity
  • Statins


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