Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no data on developmental risk associated with use in pregnant women; animal studies evaluating developmental effects are inadequate

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

Studies in pregnant rats have shown decreased fetal body weight and increased incidence of fetal variations at exposures associated with maternal toxicity and greater than those expected clinically. In rabbits, administration during the period of organogenesis resulted in no adverse effects on embryofetal development at doses expected to be approximately 10 times the maximum recommended human dose. Prenatal and postnatal development studies in rats were inadequate to assess for adverse effects during these periods of development. There are no controlled data in human 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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Benefit should outweigh risk

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

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.

This drug is highly bound to plasma proteins (96%) so if this drug were excreted into milk, levels are likely low.

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