Can I take doxylamine and pyridoxine while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Maternal risks are discussed throughout the labeling. No increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women. In the U.S. general population, the estimated background risks for major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Doxylamine succinate and pyridoxine hydrochloride (oral), Actavis Pharma, Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Small occasional doses of doxylamine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established.

“Summary of Use during Lactation”, LactMed record “Doxylamine” (LM1058), quoted verbatim. Everything LactMed reports about Doxylamine while breastfeeding.

Vitamin B6 (pyridoxine) is an essential nutrient in the human diet and is naturally found in human milk. Maternal supplementation increases milk levels in a dose-dependent manner. The recommended maternal minimum daily pyridoxine intake during pregnancy and lactation is 2 mg. The recommended adequate daily intake for neonates and infants up to 6 months of age is 0.1 mg.[1-3] Intakes of 1 to 2 mg/kg pyridoxine daily are considered safe for neonates and infants receiving isoniazid for treatment or prevention of tuberculosis infection.[4] Mothers taking a supplemental dose of 7.5 to 20 mg daily to prevent or treat B6 deficiency should have milk levels that provide an adequate B6 intake for the exclusively breastfed infant. Lower doses increase milk levels somewhat, but may not be adequate if the mother has underlying B6 deficiency. Higher doses of 100 to 200 mg daily used to prevent or treat some B6-responsive diseases have not been studied during lactation but would not be expected to expose breastfed infants to a harmful amount.

“Summary of Use during Lactation”, LactMed record “Vitamin B 6” (pyridoxine), quoted verbatim. Everything LactMed reports about Vitamin B 6 while breastfeeding.

8.2 Lactation Women should not breastfeed while using doxylamine succinate and pyridoxine hydrochloride delayed-release tablets. The molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected. Excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of doxylamine succinate and pyridoxine hydrochloride delayed-release tablets resulting in worsening of their apnea or respiratory conditions. Pyridoxine hydrochloride is excreted into breast milk. There have been no reports of adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk.

Prescribing label, section “8.2 Lactation”: Doxylamine succinate and pyridoxine hydrochloride (oral), Actavis Pharma, Inc. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.