Use is recommended only if clearly needed and the benefit outweighs the risk

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Limited data is available to inform a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; in animal models, adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity.

Animal studies have not shown teratogenic effects; embryotoxic effects have been shown at doses that have been maternally toxic. In rats, increased fetal skeletal malformations were observed with exposure corresponding to 12 times the maximum recommended human dose (MRHD) in the presence of maternal toxicity (decreased maternal weight gain). In rabbits, aborted litters were observed at exposures corresponding to 10 times or greater the MRHD, a dose that also suppressed maternal weight gain. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

Contraindicated

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

Comments:
-Due to the potential for serious adverse events in nursing infants and concern over disruption of infant lipid metabolism, mothers should avoid breastfeeding during use; some manufacturers additionally recommend avoiding breastfeeding for 5 days after the final dose.

See references