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Chlordiazepoxide Pregnancy and Breastfeeding Warnings

Chlordiazepoxide is also known as: Libritabs, Librium, Mitran, Poxi

Medically reviewed on September 28, 2016

Chlordiazepoxide Pregnancy Warnings

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 outcomes of pregnant women exposed to other psychiatric medications (e.g., anxiolytics, stimulants, and other drugs), the National Pregnancy Registry for Other Psychiatric Medications has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/

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.

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.
-Some experts recommend: Use is contraindicated in female patients planning a pregnancy or during pregnancy unless there are compelling reasons.

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

See references

Chlordiazepoxide Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.
-Some experts recommend: Use should be avoided.

Excreted into human milk: Yes

Comment: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Librium (chlordiazepoxide)." Roche Laboratories, Nutley, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  4. "Product Information. Librium (chlordiazepoxide)." Roche Laboratories, Nutley, NJ.

Further information

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

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