Dexlansoprazole has been assigned to pregnancy category B by the FDA. Animal studies at high human doses have revealed no evidence of impaired fertility or fetotoxicity. There are no controlled data in human pregnancy. Dexlansoprazole should only be given during pregnancy when benefit outweighs risk.
There are no data on the excretion of dexlansoprazole into human milk. Dexlansoprazole and its metabolites are excreted into the milk of rats. The manufacturer suggests that, because of the risk of tumorigenicity in animals, and due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
dexlansoprazole pregnancy risk
Since the full risks of using dexlansoprazole during pregnancy are not known, you should also tell your healthcare provider if you are pregnant.
What should I know before taking dexlansoprazole oral?
If you are:
Possibly Safe: NO ADEQUATE CONTROLLED HUMAN STUDIES;NO ADVERSE REPRODUCTIVE EFFECTS IN ANIMALS
Precaution: CAUTION ADVISED;SIMILAR DRUG LANSOPRAZOLE EXCRETED IN RAT;TUMORIGENIC IN RATS
An adult over 60:
Precaution: FRACTURE RISK W/ HIGH DOSE OR PROLONG. USE >1 YEAR. C.DIFFICILE RISK
Giving dexlansoprazole oral to a child under 12:
Warning: SAFETY AND EFFICACY NOT ESTABLISHED.