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Toxicological studies on omeprazole.

L Ekman, E Hansson, N Havu

    Scandinavian Journal of Gastroenterology. Supplement
    |January 1, 1985
    PubMed
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    Omeprazole, a gastric acid inhibitor, showed low acute toxicity. High doses in rats caused reversible stomach cell changes and carcinoids, linked to increased gastrin, but no reproductive or mutagenic effects were observed.

    Area of Science:

    • Pharmacology
    • Toxicology
    • Gastroenterology

    Background:

    • Omeprazole is a widely used gastric antisecretory medication.
    • Comprehensive toxicological evaluations are essential for drug safety assessment.

    Purpose of the Study:

    • To evaluate the safety profile of omeprazole through extensive toxicological studies in various animal models.
    • To identify potential adverse effects, including toxicity, carcinogenicity, reproductive effects, and mutagenicity.

    Main Methods:

    • Acute and repeated dose toxicity studies in rodents and dogs.
    • Oncogenicity studies in rats and mice.
    • Reproduction studies in rats and rabbits.
    • Mutagenicity assays (Ames test, micronucleus test, mouse lymphoma test).

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    Main Results:

    • Low acute oral toxicity (LD50 > 4 g/kg) in rodents.
    • Reversible hyperplasia of oxyntic mucosal cells and ECL-cell hyperplasia in rats, dogs, and mice at high doses, linked to hypergastrinemia.
    • Gastric carcinoids observed in rats but not mice, attributed to prolonged acid inhibition.
    • No teratogenic or fetal toxicity in reproduction studies.
    • Negative results in all short-term mutagenicity tests.

    Conclusions:

    • Omeprazole demonstrates a favorable safety profile with low acute toxicity.
    • High-dose effects on gastric mucosa in rats are reversible and linked to secondary hypergastrinemia, not direct genotoxicity.
    • The drug is not mutagenic or teratogenic, supporting its safety in therapeutic use.