Carvedilol Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.
Risk Summary: Insufficient data exists regarding use of this drug in pregnant women to determine the risk of adverse developmental outcomes.
Comments: If this drug is used during pregnancy, therapy should be stopped 2 to 3 days before the expected birth; if this is not possible then the newborn should be monitored for the first 2 to 3 days of life.
Animal studies have failed to reveal evidence of adverse developmental outcomes at clinically relevant doses. Use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
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.
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Carvedilol Breastfeeding Warnings
This drug appears to present a low risk to the breastfed infant; however, because there is no published experience during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.
This drug should not be used during breastfeeding unless the benefit outweighs the risk.
Excreted into human milk: Yes
Comment: The effects in the nursing infant are unknown; however, the possibility of the consequences of alpha and beta blockade should be considered.
See references
