Duavee Pregnancy Warnings
Use is contraindicated
AU TGA pregnancy category: D
US FDA pregnancy category: X
Comments:
-This drug is indicated for use only in postmenopausal women.
-If pregnancy occurs during treatment, this drug should be withdrawn immediately.
Bazedoxifene administered to rats at doses estimated to be 0.3 times the AUC obtained with the 20 mg dose resulted in reduced number of live fetuses and/or reductions in fetal body weights; no fetal developmental anomalies were observed. In rabbits, abortion and an increased incidence of heart and skeletal system fetal anomalies were observed at 2 times the AUC of the 20 mg dose. In both species, maternally toxicity was present. Epidemiologic studies looking at inadvertent fetal exposure to estrogen have not revealed teratogenic or fetotoxic effects. 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 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
