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Letrozole Pregnancy and Breastfeeding Warnings

Letrozole is also known as: Femara

Letrozole Pregnancy Warnings

Animal studies have revealed embryotoxicity, fetotoxicity, and teratogenicity with doses much smaller than the daily maximum recommended human dose on a mg/m2 basis. Adverse effects included increased embryo and fetal toxicity, pre- and post-implantation pregnancy loss and resorptions, fewer live fetuses, congenital malformations affecting the renal and skeletal systems, and decreased fertility including sexual inactivity in females, reproductive tract atrophy in males and females, and reductions in successful mating and 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.

Use is contraindicated in women who are or may become pregnant. AU TGA pregnancy category: D US FDA pregnancy category: X Comments: -Isolated cases of birth defects (labial fusion, ambiguous genitalia) have been reported in pregnant women exposed to this drug. -Apprise pregnant patients or those who become pregnant during treatment that this drug may cause fetal harm. -Discuss the need for adequate contraception with patients who have the potential to become pregnant, including those who are perimenopausal or recently menopausal, until their postmenopausal status is fully established.

See references

Letrozole Breastfeeding Warnings

AU and UK: Use is contraindicated during breastfeeding. US: A decision should be made to discontinue breastfeeding or to discontinue the drug, taking into account the importance of this drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Femara (letrozole)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Femara (letrozole)." Novartis Pharmaceuticals, East Hanover, NJ.

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