Clinical studies have been completed for Clomid. Under these studies 7,578 patients with fertility impediments were evaluated. During the studies pregnancy occurred in approximately 30% of these patients. Fetal abnormalities were reported for less than 1% of the babies.
Abnormalities, according to information provided by the FDA, included “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.” At the completion of these studies researchers concluded the number of deformities and issues were “within the range of that reported for the general population.”
The FDA does acknowledge, however, that there have been reports of fetal and neonatal anomalies since Clomid has been approved including “abnormal bone development, skeletal malformations of the skull, skeletal malformations of the face, nasal passages and jaw, malformations of the hands, clubfoot, malformations of the spine and joints, cardiac abnormalities, septal heart defects, muscular ventricular septal defects, coarctation of the aorta, chromosomal disorders such as Downs syndrome, ear abnormalities and deafness, gastrointestinal tract abnormalities including cleft lip and palate, imperforate anus,diaphragmatic hernia, and omphalocele.”