Librax 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
Librax 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
