What question did this study set out to answer?

To evaluate the general, reproductive, mutagenic, and oncogenic toxicological profile of the gastric acid inhibitor omeprazole across multiple animal models.

January 1, 1985Scandinavian Journal of Gastroenterology

Texicological studies on omeprazole

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Authors

LEL. EkmanUniversity of Tasmania EHEmma HanssonVrinnevisjukhuset i Norrköping NHNiilo HavuSödertälje Sjukhus

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Implication

Preclinical toxicology study demonstrates low acute toxicity but gastrin-mediated ECL-cell carcinoid development in rats, indicating secondary oncogenesis from sustained acid suppression.

Key Points

To evaluate the general, reproductive, mutagenic, and oncogenic toxicological profile of the gastric acid inhibitor omeprazole across multiple animal models.
Assessed acute oral toxicity (LD50) and repeat-dose toxicity in rodents and dogs, evaluating hematology and gastric histology.
Conducted long-term oncogenicity studies in rats and mice, reproduction studies in rats and rabbits, and mutagenicity assays including Ames, micronucleus, and mouse lymphoma tests.
Acute oral toxicity was low with an LD50 above 4 g/kg, and mutagenicity and teratogenicity assays showed no adverse effects.
Repeat dosing at 125 mumol/kg/day or higher produced reversible hyperplasia of oxyntic mucosal cells across species, alongside mild reductions in erythrocyte count, hematocrit, and hemoglobin.
Gastric carcinoids composed of ECL-cells developed in rats but not mice, driven by profound hypergastrinemia secondary to prolonged acid suppression and prevented by antrectomy.

Cite This Study

Ekman et al. (1985) studied this question.

synapsesocial.com/papers/697a6d19db261a4fbed9b6f2 https://doi.org/10.3109/00365528509095819

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Implication

Preclinical toxicology study demonstrates low acute toxicity but gastrin-mediated ECL-cell carcinoid development in rats, indicating secondary oncogenesis from sustained acid suppression.

Texicological studies on omeprazole

Discussion

Member takes

Implication

Key Points

Cite This Study

Texicological studies on omeprazole

Discussion

Member takes

Implication

Key Points

Cite This Study

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