Use is not recommended unless clearly needed

US FDA pregnancy category: C

Comment:
-Monitor for barbiturate withdrawal in neonates

Animal reproduction studies have not been conducted with this combination product. Barbiturates have been reported to readily cross the placental barrier. A 2-day old infant whose mother had taken a butalbital-containing product during the last two months of pregnancy experienced withdrawal seizures; butalbital was found in the infant's serum. Aspirin has not been associated with an increased risk of abnormalities when taken during the first trimester of pregnancy; therapeutic doses of aspirin close to term may cause bleeding in mother, fetus, or neonate. There are no controlled data on this combination product in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Aspirin, butalbital, and caffeine are excreted into human milk in small concentrations. The significance of the effects on nursing infants has not been reported, but due to the potential for serious adverse reactions in nursing infants, other agents may be preferred.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes (aspirin); Yes (barbiturates); Yes (caffeine)

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