Controversy surrounding the safety of cerivastatin

Expert Opin Drug Saf. 2002 Sep;1(3):207-12. doi: 10.1517/14740338.1.3.207.


The noted myotoxicity and subsequent withdrawal of cerivastatin from the worldwide market in August 2001 has demonstrated that the safety of statins is not a class effect. The total rhabdomyolysis rate for cerivastatin was 16 - 80 times more frequent than with other statins without providing additional efficacy. Cerivastatin has a pharmacokinetic profile (high potency, bioavailability, lipophilicity and renal excretion) that is different from other statins, which may explain the high myotoxicity rate. The cerivastatin experience has also provided insights into high-risk populations (i.e., the elderly, women, those with renal impairment, co-administration of interacting drugs) that are more prone to statin-induced myopathy. Ultimately, the lessons learned from this experience may significantly improve the safety of statin use in the future.

Publication types

  • Editorial
  • Review

MeSH terms

  • Aged
  • Area Under Curve
  • Biological Availability
  • Drug Interactions
  • Female
  • Half-Life
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / adverse effects
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / pharmacokinetics
  • Metabolic Clearance Rate
  • Pyridines* / adverse effects
  • Pyridines* / pharmacokinetics
  • Rhabdomyolysis* / chemically induced
  • Rhabdomyolysis* / mortality
  • Safety


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pyridines
  • cerivastatin