Animal studies have shown occasional anomalies (reduction of tarsals, tibia, metatarsals, malrotated limbs, gastroschisis, malformed skull, and microphthalmia). There are no adequate studies in pregnant women.

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.

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.

Use should be avoided.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: This drug may increase the risk of fetal malformations and/or withdrawal symptoms.

Comments:
-The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.
-Neonates who are exposed to chronic benzodiazepine use may be at risk for withdrawal symptoms.
-There have been reports of floppy infant syndrome (e.g., apnea, feeding difficulties, hypothermia, hypotonia/neonatal flaccidity, impaired metabolic response to cold stress, moderate respiratory depression) in children born to mothers who have taken high doses of this drug late in pregnancy or during labor; some infants may require treatment with a ventilator at birth.
-Glucuronidation of this drug may competitively inhibit the conjugation of bilirubin, leading to hyperbilirubinemia in neonates.

See references

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

Comments:
-Sedation and inability to suckle have occurred in neonates of lactating mothers taking benzodiazepines.
-Infants of lactating mothers should be observed for pharmacological effects (including sedation and irritability).
-The American Academy of Pediatrics considers this agent a drug for which the effect on nursing infants is unknown but may be of concern if exposure is prolonged.

See references