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Bazedoxifene / conjugated estrogens Pregnancy and Breastfeeding Warnings

Brand names: Duavee

Medically reviewed by Drugs.com. Last updated on Feb 6, 2024.

Bazedoxifene / conjugated estrogens 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-If pregnancy occurs during treatment, this drug should be withdrawn immediately.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

Bazedoxifene / conjugated estrogens Breastfeeding Warnings

Use is contraindicated

Excreted into human milk: Unknown (bazedoxifene); Yes (estrogen)
Excreted into animal milk: Data not available

Comments:
-Estrogen administered to nursing women decreases the quantity and quality of the milk.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2013) "Product Information. Duavee (bazedoxifene-conjugated estrogens)." Pfizer U.S. Pharmaceuticals Group

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. Ducreux M, Ychou M, Seitz JF, et al. (1999) "Irinotecan combined with bolus fluorouracil, continuous infusion fluorouracil, and high-dose leucovorin every two weeks (LV5FU2 regimen): a clinical dose-finding and pharmacokinetic study in patients with pretreated metastatic colorectal cancer." J Clin Oncol, 17, p. 2901-8
  4. (2013) "Product Information. Duavee (bazedoxifene-conjugated estrogens)." Pfizer U.S. Pharmaceuticals Group

Further information

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