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Tests for genotoxicity: principles and findings in relation to omeprazole

H J Evans1

  • 1Medical Research Council Human Genetics Unit, Western General Hospital, Edinburgh, UK.

Digestion
|January 1, 1990
PubMed

Insights

Omeprazole underwent numerous genotoxicity tests, including bacterial mutation assays and in vivo/in vitro mammalian cell tests. All studies consistently showed no evidence of genetic damage from omeprazole exposure.

Area of Science:

  • Pharmacology
  • Toxicology
  • Genetics

Background:

  • Omeprazole is a widely used proton pump inhibitor.
  • Understanding its genotoxic potential is crucial for drug safety assessment.

Purpose of the Study:

  • To comprehensively review the genotoxicity profile of omeprazole.
  • To evaluate the risk of omeprazole-induced DNA damage and mutations.

Main Methods:

  • Review of extensive genotoxicity studies.
  • Inclusion of bacterial reverse mutation assays (Ames test).
  • Analysis of in vitro and in vivo mammalian cell assays for mutations and chromosomal damage.
  • Assessment of DNA damage in rat liver cells.

Main Results:

  • Uniformly negative results across all tested genotoxicity assays.
  • No evidence of mutagenicity or clastogenicity was detected.
  • No DNA damage was observed in vivo.

Conclusions:

  • Omeprazole does not exhibit genotoxic activity.
  • The extensive testing supports a favorable safety profile regarding genetic toxicity.
  • This review consolidates evidence on omeprazole's lack of genotoxicity.

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