Goserelin Pregnancy and Breastfeeding Warnings

Brand names: Zoladex, Zoladex 3-Month

Goserelin Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk summary: This drug can cause fetal harm when administered to a pregnant patient; it has been shown to be abortifacient and teratogenic in animal studies.

Comments:
-This drug is contraindicated during pregnancy unless it is being used for palliative treatment of advanced breast cancer.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-There is an increased risk for pregnancy loss due to hormone changes caused by this drug.
-Some experts recommend verifying negative pregnancy status in female patients of reproductive potential prior to initiating therapy.

Animal studies have revealed that this drug crosses the placenta. Administration during organogenesis resulted in increased preimplantation loss and increased resorptions. There is an increase in umbilical hernia in offspring and decreased fetus and pup survival. There are no controlled data in human pregnancy.

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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Goserelin Breastfeeding Warnings

A decision should be made to either discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother; some experts consider use to be contraindicated.

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

See references

Further information

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

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