Administration to pregnant rats during organogenesis produced an increase in post-implantation loss (resorptions) and decreases in fetal body weight and number of live fetuses at exposures estimated to be 1.2 times the human exposure. In pregnant rabbits, skeletal malformations were observed at exposures lower than the expected human exposure. There are no controlled data in human pregnancy.

Animal studies have shown impaired female fertility at doses 1.2 times the estimated human dose. In male animals, impaired fertility and testicular toxicity were observed in rats at 1.5 times the expected human dose, and toxicity in the monkey reproductive tract was observed at doses lower than the expected human dose. Impact on pubertal development and the potential for impaired fertility in humans have not been adequately evaluated.

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.

Pregnancy should be avoided

US FDA pregnancy category: Not assigned

Risk Summary: There are no data in pregnant women to inform a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal studies have shown embryo-fetal toxicity at plasma drug exposures approximately equal to the recommended human dose.

Comments:
-Women should be advised of risk to their fetus and advised to avoid becoming pregnant.
-Women of reproductive potential should be advised to use appropriate effective contraception during treatment.

See references

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

Following oral administration in lactating rats, this drug is excreted in milk with a mean milk to plasma concentration ratio of 1.5 at 12 hours.

See references