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Follicle stimulating hormone Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Feb 6, 2023.

Follicle stimulating hormone is also known as: Follistim, Follistim AQ, Follistim AQ Cartridge, Gonal-F Pen, Gonal-f, Gonal-f RFF, Gonal-f RFF Pen, Gonal-f RFF Redi-ject, Puregon

Follicle stimulating hormone Pregnancy Warnings

Use is contraindicated. (AU, US)
Use during pregnancy is not indicated. (UK)

Follitropin alpha:
AU TGA pregnancy category: D
US FDA pregnancy category: X

Follitropin beta:
AU TGA pregnancy category: B2
US FDA pregnancy category: X

In animal studies, no teratogenicity was seen with follitropin alpha or beta. Animal studies of follitropin alpha showed embryotoxicity, fetotoxicity, dystocia, and post-implantation loss. There are no adequate or well-controlled studies in pregnant women. Clinical data are not sufficient to exclude a teratogenic effect. Limited data on human pregnancy indicate no malformative toxicity.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US 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.

See references

Follicle stimulating hormone Breastfeeding Warnings

In animal studies, follitropin alpha was measured in the milk in early lactation; doses up to 40 international units/kg did not affect lactation, postnatal growth, or development of the offspring. There is no information available from clinical or animal studies on the excretion of follitropin beta in milk.

Use is contraindicated. (AU)
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (UK, US)

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: There is potential for serious adverse reactions in the nursing infant.

See references

References for pregnancy information

  1. "Product Information. Follistim (follicle stimulating hormone)." Organon (2002):
  2. "Product Information. Gonal-F (follicle stimulating hormone)." Serono Laboratories Inc (2002):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Multum Information Services, Inc. Expert Review Panel"
  2. "Product Information. Follistim (follicle stimulating hormone)." Organon (2002):
  3. "Product Information. Gonal-F (follicle stimulating hormone)." Serono Laboratories Inc (2002):
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online." (2006):
  6. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.