Foscarnet Pregnancy and Breastfeeding Warnings
Brand names: Foscavir
Medically reviewed by Drugs.com. Last updated on Mar 11, 2024.
Foscarnet Pregnancy Warnings
AU, UK: Use is not recommended.
US: This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
Comments:
-Female patients of childbearing potential should use effective contraception during therapy.
-Male patients should not father a child during therapy and for up to 6 months after the last dose.
-Local protocol should be consulted regarding contraception timing.
Animal studies have revealed evidence of teratogenicity (skeletal abnormalities). There are no controlled data in human pregnancy.
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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Foscarnet Breastfeeding Warnings
Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.
This drug was excreted into the milk of rats, resulting in maternal milk levels 3 times greater than maternal blood levels.
See also
References for pregnancy information
- Product Information. Foscavir (foscarnet). Astra-Zeneca Pharmaceuticals. 2002;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp 2006.
- Cerner Multum, Inc. Australian Product Information.
References for breastfeeding information
- Product Information. Foscavir (foscarnet). Astra-Zeneca Pharmaceuticals. 2002;PROD.
- Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. Baltimore, MD: Williams & Wilkins. 1998.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Infant feeding and transmission of human immunodeficiency virus in the United States. Pediatrics. 2013;131:391-6.
- Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institutes of Health. Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. http://aidsinfo.nih.gov/contentfiles/lvguidelines/perinatalgl.pdf 2014.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
