The Basics

What is Lubiprostone?

Used to treat chronic constipation, constipation caused by opioids, or IBS.

Brand names for Lubiprostone

N/A

How Lubiprostone is classified

Chloride Channel Agonists, Gastrointestinal Agents, Membrane Transport Modulators, Laxatives

Lubiprostone During Pregnancy

Lubiprostone pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Lubiprostone while pregnant

Teratology studies with lubiprostone have been conducted in rats at oral doses up to 2000 mcg/kg/day (approximately 332 times the recommended human dose, based on body surface area), and in rabbits at oral doses of up to 100 mcg/kg/day (approximately 33 times the recommended human dose, based on body surface area). Lubiprostone was not teratogenic in rats or rabbits. In guinea pigs, lubiprostone caused fetal loss at repeated doses of 10 and 25 mcg/kg/day (approximately 2 and 6 times the highest recommended human dose, respectively, based on body surface area) administered on days 40 to 53 of gestation.There are no adequate and well-controlled studies in pregnant women. However, during clinical testing of Amitiza, six women became pregnant. Per protocol, Amitiza was discontinued upon pregnancy detection. Four of the six women delivered healthy babies. The fifth woman was monitored for 1 month following discontinuation of study drug, at which time the pregnancy was progressing as expected; the patient was subsequently lost to follow-up. The sixth pregnancy was electively terminated.Amitiza should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. If a woman is or becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to the fetus.

Taking Lubiprostone While Breastfeeding

What are recommendations for lactation if you're taking Lubiprostone?

No information is available on the use of lubiprostone during breastfeeding. The manufacturer reports that the drug and its metabolite are undetectable in rat milk and would not be expected to cause any adverse effects in a breastfed infant. Monitor the breastfed infant for diarrhea.

Maternal / infant drug levels

No information is available on the use of lubiprostone during breastfeeding. The manufacturer reports that the drug and its metabolite are undetectable in rat milk and would not be expected to cause any adverse effects in a breastfed infant. Monitor the breastfed infant for diarrhea.

Possible effects of Lubiprostone on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Lubiprostone

Linaclotide, Plecanatide, Prucalopride, Psyllium.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/None listed

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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