Use is not recommended

Type 2 Diabetes Mellitus:
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Weight Management:
AU TGA pregnancy category: B3
US: Use is contraindicated

Risk Summary: There are no data available to inform a drug associated risk for major birth defects and miscarriage. Based on animal reproduction studies, there may be risks to the fetus during pregnancy.

Comments:
-If pregnancy occurs, or a patient wishes to become pregnant, this drug should be discontinued; patients with diabetes mellitus should consider switching to insulin.
-When used for weight management, this drug is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.

Animal data have revealed evidence of increased embryofetal death and fetal abnormalities (including minor fetal skeletal abnormalities, retarded fetal weight, and visceral abnormalities). 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

In animal studies, this drug was excreted into rat milk at concentrations of approximately 50% of maternal plasma concentrations. Postnatal weight gain was reduced in the offspring of rats treated with this drug during gestation and lactation. This finding may be attributed to reduced maternal food consumption.

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

The effects in the nursing infant are unknown.

See references