Administration of this drug to pregnant rats and rabbits, at exposures up to 10 times and 0.7 times, respectively, the human exposure at the recommended daily dose (AUC at the clinical dose of 150 mg BID), caused embryo-fetal death and altered fetal growth. An increase in fetal supernumerary rib was observed at the highest tested dose and post implantation loss was also reported. 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

Risk summary:
No data available on use of this drug in pregnant women to inform a drug-related risk. Based on animal studies, this drug has a potential to cause fetal abnormalities when administered to a pregnant woman.

Comment:
Women should be apprised of potential risk to a fetus if this drug is administered during pregnancy.

See references

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Data not available
Excreted into animal milk: Unknown

Comments:
-The effects in the nursing infant are unknown.
-Because of its potential to cause adverse reactions in a breastfed child, breastfeeding is not recommended during treatment and for 2 weeks after the last dose of this drug.

See references