Remimazolam Pregnancy and Breastfeeding Warnings

Brand names: Byfavo

Medically reviewed by Drugs.com. Last updated on Feb 1, 2023.

Remimazolam Pregnancy Warnings

According to some authorities: As a precaution, use should be avoided.

US FDA pregnancy category: Not assigned.

Risk summary: No data are available on use of this drug in pregnant women; available data on use of other benzodiazepines in pregnant women have not established a drug-related risk.

Comments:
-Benzodiazepines cross the placenta and may cause respiratory depression and sedation in neonates; symptoms of sedation have occurred in infants born to mothers using benzodiazepines during later stages of pregnancy.
-Neonates exposed to benzodiazepines during pregnancy or labor should be monitored for signs of sedation and respiratory depression and should be managed accordingly.

Animal studies have failed to reveal evidence of malformations or embryofetal lethality; however, in the presence of maternal toxicity, reduced fetal weights were observed when pregnant rabbits were treated IV during organogenesis with doses about 4 times the maximum recommended human dose. Published studies in pregnant primates demonstrate administration of anesthetic and sedation drugs that block NMDA (N-methyl-D-aspartate) receptors and/or potentiate GABA (gamma-aminobutyric acid) activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours; no data are available on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans. There are no controlled data in human pregnancy; no or limited data (less than 300 pregnancy outcomes) are available from use of this drug in pregnant women.

Published data from observational studies on use of benzodiazepines during pregnancy do not report a clear link with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, no consistent pattern was noted. In addition, most of the more recent studies of benzodiazepine use during pregnancy (case-control and cohort; adjusted for confounding exposures to alcohol, tobacco, and other medications) have not confirmed these findings. No data are available on the specific effects of this drug on pregnancy. Infants exposed to benzodiazepines during the late third trimester of pregnancy or during labor have shown sedation and neonatal withdrawal symptoms.

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.

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Remimazolam Breastfeeding Warnings

An alternate agent may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-No information is available on the use of this drug during breastfeeding; because it is very short acting, nursing mothers should pump and discard breast milk for 5 hours after a dose (to minimize drug exposure to a nursing infant).
---According to some authorities: Use should be avoid, but if necessary, breastfeeding should be discontinued for 24 hours after administration.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-Sedation has been reported in infants exposed to benzodiazepines through breast milk; infants exposed to this drug through breast milk should be monitored for feeding problems, respiratory depression, and sedation.

See references

Further information

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