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Misoprostol Pregnancy and Breastfeeding Warnings

Misoprostol is also known as: Cytotec

Misoprostol Pregnancy Warnings

Misoprostol has been assigned to pregnancy category X by the FDA. Animal studies have failed to reveal evidence of fetotoxicity and teratogenicity. In studies of women undergoing elective first trimester abortion, the administration of misoprostol 400 mcg for two doses caused increased uterine contractions and bleeding in 41% of cases, and partial or complete expulsion of uterine contents in 11% of cases. In addition, frontotemporal congenital malformations in infants born of women who took misoprostol in an attempt to abort pregnancy have been reported. The use of misoprostol during pregnancy is considered contraindicated unless being used as single dose therapy following mifepristone administration for termination of early pregnancy.

Five cases of a congenital malformation, described as an "asymmetrical defect of the cranium and overlying scalp, with exposed dura mater through which the cerebrum can be seen", have been reported. The infants were all delivered of women who took 400 to 600 mcg misoprostol in the first trimester in an attempt to abort the pregnancy. A more recent evaluation of 29 pregnant women who also unsuccessfully used misoprostol in the first trimester in an attempt to abort pregnancy, failed to reveal evidence of teratogenicity. However, the use of misoprostol endangers pregnancy due to its ability to induce uterine contractions, uterine bleeding, and expulsion of uterine contents. Whether or not misoprostol is a human teratogen remains controversial. The Latin American Collaborative Study of Congenital Malformations reports an increased frequency of the following malformations in infants exposed to misoprostol in utero: arthrogryposis, hydrocephalus, holoprosencephaly, transverse limb defects, ring-shaped constrictions of the extremities, and exstrophy of the bladder.

Misoprostol Breastfeeding Warnings

Misoprostol is rapidly metabolized in the mother to misoprostol acid which is biologically active and is excreted in human breast milk. There are no published reports of adverse effects of misoprostol in breast-feeding infants of mothers taking misoprostol. The manufacturer recommends that caution should be exercised when misoprostol is administered to a nursing woman.

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