Zoladex Pregnancy Warnings
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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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.
Use is contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: D in patients with advanced breast cancer; X in patients with endometriosis and endometrial thinning
Comments:
-This drug is contraindicated during pregnancy unless it is being used for palliative treatment of advanced breast cancer.
-This drug can harm a developing fetus.
-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.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
See references
