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Chlordiazepoxide / clidinium Pregnancy and Breastfeeding Warnings

Chlordiazepoxide / clidinium is also known as: Chlordinium, Clindex, Librax

Medically reviewed by Drugs.com. Last updated on Sep 18, 2020.

Chlordiazepoxide / clidinium Pregnancy Warnings

Animal studies have failed to reveal evidence of congenital abnormalities, effects on fertility, effects on gestation, and effects on offspring viability. In a clinical study, some animal models have revealed evidence of a decrease in fertilization rate, which may result from a lack of interest in mating. There are no controlled data using any of the drugs, alone or in combination, in human pregnancy.

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.

Use should be avoided during the early stages of pregnancy, and this drug should be used during pregnancy only if the benefit outweighs the risk to the fetus thereafter.

US FDA pregnancy category: Not assigned.

Risk Summary: An increase in congenital malformations has been suggested with minor tranquilizer use (e.g., chlordiazepoxide, diazepam, meprobamate), especially during the first trimester.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-If used during pregnancy, monitor the newborn for acute withdrawal syndrome symptoms during the postnatal period.

See references

Chlordiazepoxide / clidinium Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes (chlordiazepoxide); Unknown (chlordiazepoxide-clidinium; clidinium)
Excreted into animal milk: Yes (chlordiazepoxide-clidinium; clidinium)

Comments:
-Use may inhibit lactation.
-Some experts state that chlordiazepoxide and its metabolites may accumulate in breastfed infants, especially in preterm or newborn infants; an alternative drug (e.g., lorazepam, midazolam, oxazepam) may be considered in this patient population.
-Chlordiazepoxide should be avoided during breastfeeding by the American Academy of Pediatrics (AAP).

See references

References for pregnancy information

  1. "Product Information. Librax (chlordiazepoxide-clidinium)." Valeant Pharmaceuticals, Costa Mesa, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 7th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2005):

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 7th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2005):
  3. "Product Information. Librax (chlordiazepoxide-clidinium)." Valeant Pharmaceuticals, Costa Mesa, CA.

Further information

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