Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk summary: There are no data on the developmental risk associated with use during human pregnancy; based on animal data, this drug may cause fetal harm.

Animal studies have revealed adverse developmental effects at exposures greater than those used clinically. In rats exposed to this drug during organogenesis, decreased fetal weight and skeletal ossification were observed; exposure throughout gestation and lactation revealed decreased pup body weight at the highest dose tested. In rabbits, an increase in fetal visceral and skeletal variations were observed at the highest dose tested, a dose which was also associated with minimal maternal toxicity. There are no controlled data in human pregnancy.

Clinical Considerations: Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

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.

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This drug has been found in the milk of lactating rats at levels approximately 2-fold higher than that in maternal plasma.

Benefit should outweigh risk

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-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.

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