Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
There are limited safety data from the use of cholic acid in pregnant women. Pregnancies with normal outcomes have been reported in women taking cholic acid.
The limited data from animal studies do not indicate direct reproductive toxicity (see section 5.3). The use of cholic acid may be considered during pregnancy if the doctor considers that the benefits to the patient outweigh the possible risk.

Limited published case reports discuss pregnancies in women taking cholic acid for 3β-HSD deficiency resulting in healthy infants. These reports may not adequately inform the presence or absence of drug-associated risk with the use of CHOLBAM during pregnancy. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Breast-feeding
There is insufficient information on the excretion of cholic acid and its metabolites in human milk.
Available data in animals have shown excretion of cholic acid in milk (see section 5.3). At therapeutic doses, no effects on the breast-fed newborn infant are anticipated since the systemic exposure of the breast -feeding mother to cholic acid is negligible (see section 5.2). Cholic acid can be used during breast-feeding if the doctor considers that the benefits to the patient outweigh the possible risk.

Fertility
There are no data on the effects of cholic acid on fertility. At therapeutic doses, no effect on fertility is anticipated.