Atenolol Pregnancy and Breastfeeding Warnings

Brand names: Tenormin

Atenolol Pregnancy Warnings

Use during pregnancy only if the benefit outweighs risk

US FDA pregnancy category: D
AU TGA pregnancy category: C

Comments:
-Apprise women of potential risk to fetus if pregnant or become pregnant while taking this drug.
-After birth, monitor infants for the signs of beta blockade, generally expected in first 3 days.

Atenolol crosses the placental barrier and appears in cord blood. Administration of this drug during the second trimester of pregnancy has been associated with small for gestational age births; this may be for related to duration of use. There are no studies for use in the first trimester, however, infant risk cannot be ruled out. Beta-blocker use has been associated with decreased placental perfusion which may lead to intra-uterine deaths, immature and premature deliveries. Neonates exposed to this drug during the third trimester are at risk for adverse reactions due to beta-blockade. There are no adequate and well-controlled studies in pregnant women.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite risks.

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.

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Atenolol Breastfeeding Warnings

Use with caution

Excreted into human milk: Yes

Comments:
-Clinically significant bradycardia has occurred; monitor breastfed infants, especially newborns and with high maternal doses, for signs of beta blockade.

This drug is excreted into human breast milk at a ratio of 1.5 to 6.8 when compared to the plasma concentration. Signs of beta blockade, such as bradycardia, hypotension, and hypoglycemia, have been observed in breastfed infants. Neonates younger than 3 months of age, infants with impaired renal function, and high maternal doses, are at increased risk due to high renal excretion of this drug and its potential for accumulation in the breastmilk. The risk in older infants appears to be lower.

See references

Further information

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