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Clomiphene Pregnancy and Breastfeeding Warnings

Clomiphene is also known as: Clomid, Milophene, Serophene

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.

See references

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.

See references

References for pregnancy information

  1. Ford WD, Little KE "Fetal ovarian dysplasia possibly associated with clomiphene." Lancet 2 (1981): 1107
  2. Marchbanks PA, Coulam CB, Annegers JF "An association between clomiphene citrate and ectopic pregnancy: a preliminary report." Fertil Steril 44 (1985): 268-70
  3. Ahlgren M, Kallen B, Rannevik G "Outcome of pregnancy after clomiphene therapy." Acta Obstet Gynecol Scand 55 (1976): 371-5
  4. Elwood JM "Letter: Clomiphene and anencephalic births." Lancet 1 (1974): 31
  5. Berman P "Letter: Congenital abnormalities associated with maternal clomiphene ingestion." Lancet 2 (1975): 878
  6. Harlap S "Ovulation induction and congenital malformations." Lancet 2 (1976): 961
  7. Biale Y, Leventhal H, Altaras M, Ben-Aderet N "Anencephaly and clomiphene-induced pregnancy." Acta Obstet Gynecol Scand 57 (1978): 483-4
  8. Burke M "Letter: Ectopic pregnancy, hydatidiform mole and clomiphene." Lancet 1 (1976): 41-2
  9. "Product Information. Clomid (clomiphene)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  10. Kurachi K, Aono T, Minagawa J, Miyake A "Congenital malformations of newborn infants after clomiphene-induced ovulation." Fertil Steril 40 (1983): 187-9
  11. Wajntraub G, Kamar R, Pardo Y "Hydatidiform mole after treatment with clomiphene." Fertil Steril 25 (1974): 904-5
  12. Laing IA, Steer CR, Dudgeon J, Brown JK "Clomiphene and congenital retinopathy." Lancet 2 (1981): 1107-8

References for breastfeeding information

  1. Loraine JA, Bell ET, Harkness RA, Harrison MT "The effect of clomiphene on hormone excretion in patients with galactorrhoea." Acta Endocrinol (Copenh) 52 (1966): 527-34
  2. "Product Information. Clomid (clomiphene)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  3. Weir JH "Postthoracotomy galactorrhea successfully treated with clomiphene citrate." Am J Obstet Gynecol 111 (1971): 106-7
  4. Kalir R, David MP, Kraicer PF "Clomiphene citrate in suppression of puerperal lactation." Am J Obstet Gynecol 122 (1975): 570-2

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