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Chlordiazepoxide / clidinium Pregnancy and Breastfeeding Warnings

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

Medically reviewed on September 28, 2016

Chlordiazepoxide / clidinium Pregnancy Warnings

Animal studies did not show congenital abnormalities or adverse effects on newborns or dams at chlordiazepoxide doses of 80 mg/kg or less, but at 100 mg/kg/day there was a significant decrease in the fertilization rate and a marked decrease in the viability and body weight of the offspring, which might be attributed to sedative activity decreasing the interest in mating and nursing and care of the young. Animal studies of clidinium showed no adverse effect on fertilization, gestation, viability of offspring, and no increase in congenital abnormalities compared to placebo. An animal study of chlordiazepoxide/clidinium combination had a slight decrease in animals surviving during lactation, possibly because inhibition of lactation; a second study showed a slight decrease in pregnant females at 25 mg/kg chlordiazepoxide with 12.5 mg/kg clidinium and animals surviving until weaning, otherwise there were no differences from the control groups, and no signs of congenital abnormalities. There are no controlled data 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.

US FDA pregnancy category: Not assigned

Comments:
-An increased risk of congenital malformations associated with minor tranquilizers (chlordiazepoxide, diazepam, meprobamate) during the first trimester has been suggested in several studies.
-Use during the first and last trimesters should be avoided.
-If patients become pregnant or intend to become pregnant, discuss discontinuing this drug.

See references

Chlordiazepoxide / clidinium Breastfeeding Warnings

Use is not recommended. (US)
Contraindicated (UK)

Excreted into human milk: Yes

Comments:
-This drug may inhibit lactation.
-Clidinium in milk may cause atropinic effects in the child.

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.

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