Mifepristone Pregnancy and Breastfeeding Warnings
Mifepristone Pregnancy Warnings
Mifepristone for abortion: Because mifepristone is indicated for use during early pregnancy, it has not been formally assigned to a pregnancy category by the FDA. Fetal deformities have been reported in animal studies but were most likely the result of mechanical effects of uterine contractions caused by decreased progesterone levels. Controlled data in human pregnancy have illustrated mifepristone's labeled efficacy. The manufacturer recommends mifepristone only be administered for termination of early pregnancy (through 49 days) after the treatment procedure, and its effects, have been discussed with the patient. Mifepristone for hyperglycemia: Mifepristone has been assigned to pregnancy category X by the FDA. Mifepristone can cause fetal harm when administered to a pregnant woman because the use of mifepristone results in pregnancy loss. The inhibition of both endogenous and exogenous progesterone by mifepristone at the progesterone receptor results in pregnancy loss. If mifepristone is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Mifepristone use is considered contraindicated in pregnancy.
Mifepristone Breastfeeding Warnings
There are no data on the excretion of mifepristone into human milk. Because many drugs are excreted into human milk and because of the risk of adverse effects in the nursing infant, a decision should be made whether to discontinue the drug or discontinue nursing, taking into account the importance of the drug to the mother.
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