Buspirone Pregnancy and Breastfeeding Warnings

Brand names: BuSpar, Bucapsol, Vanspar

Buspirone Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Animal studies have failed to reveal evidence of fetal harm or adverse effects on fertility. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

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 references

Further information

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

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