Animal studies have shown evidence of maternal toxicity (decreased body weight gain and food consumption, and abortions) and developmental toxicity (decreased fetal body weight and delayed skeletal ossification) with oral doses of 150 mg/kg/day or greater, which corresponds to 3 or more times the human estimated exposure, and IV doses of 7.2 mg/kg/day or greater, which is 8-fold higher than the estimated human systemic exposure. 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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Benefit should outweigh risk

AU TGA pregnancy category: B3
US FDA pregnancy category: B

See references

Safety has not been established

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

Comments: The effects in the nursing infant are unknown, however, exposure to the breastfeeding infant is likely to be negligible since minimal systemic exposure is observed in adults.

See references