Administration to rats during late gestation at a dose 7 times the maximum human dose (MHD) had no adverse effects on the mothers or offspring. There is no information on teratogenicity. Weight loss is not recommended during pregnancy due to the potential for fetal harm. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Not recommended

AU TGA pregnancy category: B2
US FDA pregnancy category: X

Risk Summary: Maternal weight loss may result in fetal harm.

Comments:
-Weight loss offers no potential benefit to a pregnant woman; a minimum weight gain, and no weight loss, is currently
recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy.
-If a women becomes pregnant during therapy, she should be apprised of the potential harm to a fetus.

See references

Use should be avoided during breastfeeding

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

Comments: Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

See references