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Clomiphene citrate is a drug of considerable pharmacologic potency. With careful selection and proper management of the patient, Clomiphene citrate has been demonstrated to be a useful therapy for the anovulatory patient desiring pregnancy.
Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning Clomiphene citrate therapy.
Precautions
Clomiphene citrate should not be administered during pregnancy. Clomiphene citrate may cause fetal harm in animals. Although no causative evidence of a deleterious effect of Clomiphene citrate therapy on the human fetus has been established, there have been reports of birth anomalies which, during clinical studies, occurred at an incidence within the range reported for the general population.
To avoid inadvertent Clomiphene citrate administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation occurs. The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle. The next course of Clomiphene citrate therapy should be delayed until these conditions have been excluded.
Fetal/Neonatal Anomalies and Mortality
The following fetal abnormalities have been reported subsequent to pregnancies following ovulation induction therapy with Clomiphene citrate during clinical trials. Each of the following fetal abnormalities were reported at a rate of <1% (experiences are listed in order of decreasing frequency): Congenital heart lesions, Down syndrome, club foot, congenital gut lesions, hypospadias, microcephaly, harelip and cleft palate, congenital hip, hemangioma, undescended testicles, polydactyly, conjoined twins and teratomatous malformation, patent ductus arteriosus, amaurosis, arteriovenous fistula, inguinal hernia, umbilical hernia, syndactyly, pectus excavatum, myopathy, dermoid cyst of scalp, omphalocele, spina bifida occulta, ichthyosis, and persistent lingual frenulum. Neonatal death and fetal death/stillbirth in infants with birth defects have also been reported at a rate of <1%. The overall incidence of reported birth anomalies from pregnancies associated with maternal Clomiphene citrate ingestion during clinical studies was within the range of that reported for the general population.
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