This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk, especially during the first trimester of pregnancy.

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

Risk Summary: Use may be associated with an increased risk of congenital malformations. There are no adequate studies of this drug in pregnant women to inform a drug-related risk.

Comments:
-The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms.
-Benzodiazepines may cause fetal harm when administered during pregnancy.
-The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.
-A pregnancy exposure registry is available.

Several studies have suggested an increased risk of congenital malformations associated with the use of minor tranquilizers (i.e., chlordiazepoxide, diazepam, meprobamate) during the first trimester of pregnancy. There are no controlled data in human pregnancy.

To monitor maternal-fetal outcome of pregnant women exposed to antiepileptic drugs, the North American Antiepileptic Drug (NAAED) Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: http://www.aedpregnancyregistry.org/

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.

See references

Use is not recommended.
-Some experts recommend: 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:
-The American Academy of Pediatrics considers this agent a drug for which the effect on nursing infants is unknown but may be of concern.
-Chronic administration of diazepam to nursing mothers has been reported to cause their infants to become lethargic and to lose weight.

See references