Atropine Pregnancy and Breastfeeding Warnings

Brand names: Atreza, AtroPen, Sal-Tropine

Medically reviewed by Drugs.com. Last updated on Sep 24, 2024.

Atropine Pregnancy Warnings

Safety has not been established during pregnancy; use is recommended only if clearly needed and the benefit outweighs the risk.

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

Risk summary: Inadequate data available on the use of this drug in pregnant women to inform of a drug-related risk.

Animal studies are insufficient regarding reproductive toxicity; one study showed no evidence of fetal harm, another high dose study showed a teratogenic effect in one animal species. This drug crosses the placenta and may cause tachycardia in the fetus. There are no controlled data in human pregnancy, however it has been used by a large number of pregnant women without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus being observed.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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

Atropine Breastfeeding Warnings

This drug should be used only if absolutely necessary.

Excreted into human milk: Yes

Comments:
-Small amounts appear in breast milk and may have antimuscarinic effects in the infant.
-Lactation may be inhibited.
-Infants are usually very sensitive to the effects of this drug.

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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