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Amitriptyline / chlordiazepoxide Pregnancy and Breastfeeding Warnings

Amitriptyline / chlordiazepoxide is also known as: Limbitrol, Limbitrol DS

Medically reviewed on January 29, 2018

Amitriptyline / chlordiazepoxide Pregnancy Warnings

Safety has not been established during pregnancy; use should be avoided.

US FDA pregnancy category: Not Assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.
-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.
-Neonatal withdrawal and depression of the newborn may occur in neonates exposed to this drug.

Animal studies with the combination amitriptyline-chlordiazepoxide have not been reported. Animal studies with chlordiazepoxide have revealed evidence of decreased viability and body weight at maternally toxic doses. There are no controlled data in human pregnancy.

Amitriptyline use during the first trimester has resulted in case reports of limb reduction anomalies and other malformations. Use of chlordiazepoxide during gestation resulted in reports of major skeletal anomalies, neonatal withdrawal; when used close to birth, depression of the newborn was reported.

To monitor the outcomes of pregnant women exposed to antidepressants, a National Pregnancy Registry for Antidepressants has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

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.

See references

Amitriptyline / chlordiazepoxide Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Yes (amitriptyline); Unknown (chlordiazepoxide)
Excreted into animal milk: Data not available (chlordiazepoxide)

Comments:
-Amitriptyline is considered a drug whose effect on the nursing infant is unknown but may be of concern by the American Academy of Pediatrics.
-The WHO considers amitriptyline compatible with breastfeeding with daily doses up to 150 mg.
-Chlordiazepoxide and its metabolites may accumulate in breastfed infants.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  2. "Product Information. Amitriptyline-Chlordiazepoxide (amitriptyline-chlordiazepoxide)." Mylan Pharmaceuticals Inc, Morgantown, WV.

References for breastfeeding information

  1. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]):
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  3. 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 -]):
  4. "Product Information. Amitriptyline-Chlordiazepoxide (amitriptyline-chlordiazepoxide)." Mylan Pharmaceuticals Inc, Morgantown, WV.

Further information

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

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