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Lubiprostone Pregnancy and Breastfeeding Warnings

Lubiprostone is also known as: Amitiza

Overview

If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lubiprostone while you are pregnant. It is not known if Lubiprostone is found in breast milk. Do not breast-feed while taking Lubiprostone.

Lubiprostone Pregnancy Warnings

During clinical testing of lubiprostone, six women became pregnant. Lubiprostone was discontinued upon pregnancy detection. Four of the six women delivered healthy babies. The fifth woman was monitored for one 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. In animal studies, the number of implantation sites and live embryos were significantly reduced in the high dosage group as compared to control. The number of dead or resorbed embryos was also higher in the high dose group compared to the control group, but was not statistically significant.

Lubiprostone has been assigned to pregnancy category C by the FDA. Animal studies have demonstrated the potential to cause fetal loss when lubiprostone was administered at repeated doses that were approximately 2 to 6 times the human dose based on body surface area. There are no controlled data in human pregnancy. Lubiprostone should only be used during pregnancy when benefit outweighs risk. Women of childbearing potential should have a negative pregnancy test prior to beginning therapy with lubiprostone and should be capable of complying with effective contraceptive measures. If a woman becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to the fetus.

Lubiprostone Breastfeeding Warnings

There are no data on the excretion of lubiprostone into human milk. The manufacturer recommends that 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.

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