Clomiphene Pregnancy and Breast Feeding Warnings
Clomiphene is also known as: Clomid, Serophene
Overview
Do not use Clomiphene 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 Clomiphene is found in breast milk. Do not breast-feed while taking Clomiphene .
Clomiphene Pregnancy Warnings
Clomiphene has been assigned to pregnancy category X by the FDA. Animal studies have revealed evidence of fetotoxicity. There are no controlled studies in human pregnancy. The incidence of clomiphene-associated birth abnormalities noted during clinical trials was similar to that observed in the normal population. Postmarketing surveillance has revealed fetal and neonatal anomalies. Clomiphene use is contraindicated during pregnancy.
A number of cases of anencephaly have been reported in clomiphene-induced pregnancy. It is not known if this effect is drug-related or due to the underlying infertility. Fetal abnormalities reported during clinical trials include congenital heart lesions, Down's syndrome, hydatidiform mole, club foot, congenital gut lesions, hypospadias, microcephaly, harelip, cleft palate, congenital hip, hemangioma, undescended testicles, polydactyly, conjoined twins and teratomatous malformation, patent ductus arteriosus, syndactyly, pectus excavatum myopathy, dermoid cyst of the scalp, arteriovenous fistula, inguinal hernia, umbilical hernia, omphalocele, spina bifida occulta, ichthyosis, persistent lingual frenulum, and still births. Postmarketing surveillance reporting has revealed the following fetal/neonatal abnormalities: delayed development, mental retardation, abnormal bone development, tissue malformation, abnormal organ development, dwarfism, chromosomal disorders, and neural tube defects. The rate of spontaneous abortions is 20.4% and the stillborn rate is approximately 1%.
Clomiphene Lactation Warnings
There are no data on the excretion of clomiphene into human milk. The manufacturer recommends that caution be used when administering clomiphene to nursing women.
Dosages of 100 mg/day for 5 days have suppressed puerperal lactation. In a small study of women with galactorrhea, administration of clomiphene was associated with a rapid cessation of galactorrhea.
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