Clomiphene Pregnancy and Breastfeeding Warnings

Brand names: Clomid, Milophene, Serophene

Clomiphene Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: B3
US FDA pregnancy category: X

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-To avoid inadvertent administration during early pregnancy, appropriate tests should be performed during each treatment cycle to determine whether ovulation and/or pregnancy occurs.
-Evaluate patients carefully to exclude ovarian enlargement or ovarian cyst formation between each cycle; the next course of therapy should be delayed until these conditions have been excluded.

Animal reproductive toxicology studies have demonstrated increased embryofetal loss and structural malformations in offspring. Available human data does not suggest increased risk for congenital anomalies above the background population risk when used as indicated. Due to the small number of cases of congenital anomalies in women treated with this drug, epidemiologic studies were only able to rule out large differences in risk. Additionally, available data do not suggest an increased rate of spontaneous abortion among subfertile women treated with this drug. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Clomiphene Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-May suppress lactation by lowering serum prolactin and would likely interfere with lactation in a nursing mother.

See references

Further information

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