Use is considered acceptable.

US FDA pregnancy category: Not assigned.

Risk Summary: Malformative risk with any of the drugs, alone or in combination, in pregnant women is unlikely based on epidemiological studies.

Comment: This drug is intended for use in pregnant patients who do not respond to conservative treatment.

Epidemiological meta-analyses have failed to reveal evidence of fetal abnormalities, malformations, or teratogenicity using doxylamine and pyridoxine alone and in combination. There are no controlled data using any of the drugs, alone or in combination, in human pregnancy.

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

Infants with apnea and/or other respiratory syndromes may be more susceptible to the effects of sedation, which could worsen their conditions.

Use is not recommended, and 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 (pyridoxine); Unknown (doxylamine)
Excreted into animal milk: Data not available (doxylamine)

Comments:
-Some experts state that use of the combination product should not be used in patients who are breastfeeding.
-Pyridoxine is considered compatible with breastfeeding by the WHO.
-Excitement, irritability, and sedation have been reported in nursing infants exposed to doxylamine.

See references