At doses exceeding maximum recommended daily doses (MRDD), animal studies have revealed evidence of decreased birth, and pre and post weaning weights, increased mortality, altered estrus cyclicity and delays in time to mating, and placental transfer of the drug. A Pregnancy Registry (1998 to 2018) has not identified any pattern of congenital anomalies or other adverse birth outcomes; although caution is advised in interpreting this data as the number of reports was low and did not provide significant power to detect an increase risk of individual birth defects associated with use of this drug. For women with migraine, there is an increased risk of adverse perinatal outcomes in the mother, including pre-eclampsia and gestational hypertension. There are no controlled data in human pregnancy

AU TGA pregnancy category B1: 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 not shown 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.

Benefit should outweigh risk

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk Summary: There is insufficient data to draw conclusions about drug-associated risk for major birth defects and miscarriage; animal studies do not indicate harmful effects at dose levels that exceed therapeutic dose levels with respect to the development of the embryo or fetus, or the course of gestation, parturition and post-natal development.

Comments:

See references

Benefit should outweigh risk

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

Comments:
-Infant risk should be minimized by avoiding breastfeeding for 24 hours after administration of this drug.
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.

This drug is extensively excreted into rat milk, at a level 5 or more times maternal plasma levels. Administration to lactating rats at approximately 10 times anticipated maximum clinical exposure resulted in significant reduction in pup body weight gain during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references