Lubiprostone Pregnancy and Breastfeeding Warnings

Brand names: Amitiza

Medically reviewed by Drugs.com. Last updated on Oct 9, 2023.

Lubiprostone Pregnancy Warnings

UK: Use is not recommended during pregnancy and in women of childbearing potential not using contraception.
US: Potential benefit should outweigh possible risk to the fetus.

US FDA pregnancy category: C

Some animal studies revealed a dose-dependent increase in fetal loss but no increase in structural malformations. Other animal data showed increased incidences of early resorptions and soft tissue malformations, but those effects were likely secondary to maternal toxicity. Animal studies also demonstrated significant reduction of implantation sites and live embryos, but no effect on male and female fertility and reproductive function at oral doses up to 1000 mcg/kg/day. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Lubiprostone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: No

Comments:
-A risk to the nursing infant cannot be excluded.
-Breastfed infants should be monitored for diarrhea because this drug increases intestinal fluid secretion and motility.

See references

Further information

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