Clorazepate Pregnancy and Breastfeeding Warnings

Brand names: Tranxene, Tranxene SD, Tranxene T-Tab

Medically reviewed by Drugs.com. Last updated on Aug 2, 2023.

Clorazepate Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: Use of other benzodiazepines (e.g., chlordiazepoxide, diazepam, meprobamate) during the first trimester of pregnancy 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 malformations and/or withdrawal symptoms.
-Benzodiazepines may cause fetal harm when administered during pregnancy.
-If this drug is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuation if she intends to become pregnant or is pregnant.
-A pregnancy exposure registry is available.

Several studies have suggested that fetal abnormalities and/or increased risk of congenital malformations may be 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/

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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Clorazepate Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Timing breastfeeding with respect to dosing is not predicted to be of benefit in decreasing infant exposure, as this drug and its active metabolite have long half-lives.
-The American Academy of Pediatrics classifies other benzodiazepines as drugs whose effects on the nursing infant are unknown but may be of concern.

See references

Further information

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