Diclofenac/misoprostol Pregnancy and Breast Feeding Warnings
Diclofenac/misoprostol is also known as: Arthrotec
Overview
Do not use Diclofenac/Misoprostol if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Diclofenac/Misoprostol is found in breast milk. Do not breast-feed while taking Diclofenac/Misoprostol .
Diclofenac/misoprostol Pregnancy Warnings
Diclofenac-misoprostol has been assigned to pregnancy category X by the FDA. Animal studies have failed to reveal evidence of fetotoxicity and teratogenicity for either drug. While there were no literature reports located linking the use of diclofenac in pregnancy with birth defects, use late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. 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 diclofenac-misoprostol during pregnancy is considered contraindicated.
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.
Diclofenac/misoprostol Lactation Warnings
There are no data on the excretion of misoprostol or misoprostol acid into human milk, however, diclofenac is excreted into human milk. The manufacturer recommends diclofenac-misoprostol not be used during lactation.
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