In long-term studies in rats, omeprazole produced a dose-related increase in gastric carcinoid tumours. Biopsy specimen from human stomach has not detected risk from short-term exposure to omeprazole. Further human data on the effect of sustained hypochlorhydria and hypergastrinemia are needed to rule out the possibility of an increased risk for the development of tumors in humans receiving long-term therapy with Omicap (omeprazole).
Use in pregnancy & lactation: The safety of Omicap in human pregnancy has not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether omeprazole is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from omeprazole and because of the potential for tumorigenicity shown for omeprazole in rat carcinogenic studies, a decision should be made whether to discontinue nursing or to discontinue omeprazole, taking into account the importance of the drug to the mother.
Use in children: Safety and effectiveness in children have not been established.