This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.

Risk Summary: Available data on use of this drug in pregnant women have not identified a drug-related risk (e.g., adverse fetal outcomes, birth defects, miscarriage).

Comment:
-Use should be avoided in patients with severe preeclampsia as eclamptic seizures have occurred in this population.
-Some experts recommend avoiding unnecessary use of this drug during the first trimester.

Animal studies showed no harm with daily intravenous administration in one model, and embryotoxicity in another animal model at doses 100 times the human transdermal dose. Parenteral administration before the onset of labor may cause central nervous system and/or respiratory depression in the neonate. 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 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

Use should be avoided.

Excreted into human milk: Yes

Comments:
-Small amounts of this drug are excreted in breast milk.
-This drug may inhibit lactation.

See references