Buspirone Pregnancy and Breastfeeding Warnings
Buspirone Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: B1
US FDA pregnancy category: B
Animal studies have not revealed any fetal damage or fertility impairment. There are no controlled data in human pregnancy.
AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Buspirone Breastfeeding Warnings
This drug should not be used during breastfeeding unless clinically necessary.
Excreted into human milk: Yes
Comments:
-Limited information indicates maternal doses up to 45 mg daily of this drug produce low levels in milk.
-This drug increases serum prolactin; however, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.
-There is no information available on the long-term use of this drug during breastfeeding.
An exclusively breastfed 11-week-old infant whose mother took 10 mg of this drug and 300 mg of venlafaxine daily showed no adverse reactions.
See also
References for pregnancy information
- (2002) "Product Information. Buspar (buspirone)." Bristol-Myers Squibb
References for breastfeeding information
- (2002) "Product Information. Buspar (buspirone)." Bristol-Myers Squibb
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.