Diclegis Use In Pregnancy & Lactation

Pregnancy: Diclegis is intended for use in pregnant women.
A large amount of data on pregnant women indicates no malformative nor feto/neonatal toxicity of doxylamine succinate and pyridoxine hydrochloride.
Breast-feeding: 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 apnoea or other respiratory syndromes may be particularly vulnerable to the sedative effects of Diclegis resulting in worsening of their apnoea 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.
A risk to breastfed infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Diclegis therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: Diclegis caused no impairment of fertility or reproductive performance in rats (see Pharmacology: Toxicology: Preclinical safety data under Actions). No human data available.