Skip to Content

Lubiprostone Pregnancy and Breastfeeding Warnings

Lubiprostone is also known as: Amitiza

Lubiprostone Pregnancy Warnings

There are no controlled data in human pregnancy. A dose dependent increase in fetal loss was observed in pregnant animals that received lubiprostone doses equivalent to 0.2 to 6 times the maximum recommended human dose (MRHD) based on body surface area (mg/m2). Animal studies did not show an increase in structural malformations. 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.

FDA pregnancy category: C Use lubiprostone only if clearly needed and benefit outweighs potential risk. Use of adequate methods of contraception should be encouraged.

See references

Lubiprostone Breastfeeding Warnings

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

Lubiprostone increases fluid secretion in the intestine and intestinal motility; therefore, breast-fed infants of mothers taking lubiprostone should be monitored for diarrhea.

See references

References for pregnancy information

  1. "Product Information. Amitiza (lubiprostone)." Sucampo Pharmaceuticals Inc, Bethesda, MD.

References for breastfeeding information

  1. "Product Information. Amitiza (lubiprostone)." Sucampo Pharmaceuticals Inc, Bethesda, MD.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.