Clomiphene Pregnancy and Breastfeeding Warnings
Clomiphene Pregnancy Warnings
Human data does not suggest an increased congenital anomaly risk above that observed in the normal population when used as indicated. Animal studies have shown increased embryo-fetal loss and structural malformations. 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. 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. 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. 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.
FDA pregnancy category: X Use of DRUG is contraindicated. Comments: If pregnancy occurs during therapy, the patient should be informed of potential fetal risks.
Clomiphene Breastfeeding Warnings
Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.
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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