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Voriconazole Pregnancy and Breastfeeding Warnings

Voriconazole is also known as: Vfend

Medically reviewed on Sep 6, 2018

Voriconazole Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit clearly outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: D

Comments:
-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 risk to the fetus.
-Women of childbearing potential should use effective contraception during therapy.

Animal studies have revealed evidence of teratogenicity (e.g., cleft palates, hydronephrosis/hydroureter), embryotoxicity, increased gestational length, dystocia, and embryolethality at doses ranging from 0.3 to 6 times (when adjusted for body surface area) the recommended maintenance dose. There are no controlled data in human pregnancy. Voriconazole can cause fetal harm when administered to a pregnant woman.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

See references

Voriconazole Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother; breastfeeding must be stopped on initiation of therapy.

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

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  4. "Product Information. VFEND (voriconazole)." Pfizer U.S. Pharmaceuticals, New York, NY.
  5. Sabo JA, Abdel-Rahman SM "Voriconazole: a new triazole antifungal." Ann Pharmacother 34 (2000): 1032-43

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. VFEND (voriconazole)." Pfizer U.S. Pharmaceuticals, New York, NY.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Sabo JA, Abdel-Rahman SM "Voriconazole: a new triazole antifungal." Ann Pharmacother 34 (2000): 1032-43
  5. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

Further information

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

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