Quazepam Pregnancy and Breastfeeding Warnings

Brand names: Doral

Medically reviewed by Drugs.com. Last updated on Oct 10, 2024.

Quazepam Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Neonates may show signs of sedation, hypotonia, and respiratory depression.
-Monitor neonates with prenatal or perinatal exposure to this drug for signs of sedation, respiratory depression, hypotonia, and feeding difficulties.
-Monitor and appropriately treat neonates who were exposed to this drug during pregnancy with signs of withdrawal.

Animal models have failed to reveal evidence of major drug-related malformations. However, minor fetal skeletal variations occurred (delayed ossification of the sternum, vertebrae, distal phalanges and supraoccipital bones) when doses 70 and 400 times the human dose were used. Even though early studies have reported an increased risk of congenital malformations in humans with other benzodiazepines, there was no clear association to major birth defects.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by visiting https://womensmentalhealth.org/research/pregnancyregistry/

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

Quazepam Breastfeeding Warnings

Use with caution.

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, especially when used for long periods.
-This drug and its metabolites are excreted into human milk and both the drug and its metabolites may accumulate in the breastfed infant. Some experts recommend that an alternative drug should be considered, especially for newborn or preterm infants (e.g., zaleplon, zolpidem).

Based on a study in 4 women receiving a single dose of 15 mg, estimated human milk concentrations of 2.3% maternal weight-adjusted dose are achieved. Due to the expected accumulation with repeat dosing, an exclusively breastfed infant may receive 0.19% of the mother's absolute dose or 4% of the maternal weight-adjusted dose.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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