Reyvow Pregnancy Warnings
Benefit should outweigh risk
US FDA pregnancy category: Not assigned
Risk Summary: There are no data on the developmental risk associated with use of this drug in pregnant women; adverse effects on development have been observed in animals at exposures less than those expected clinically.
Comments:
-There are maternal and fetal risks associated with migraine; published data have suggested women with migraine may be at increased risk for preeclampsia and gestational hypertension during pregnancy.
Rabbits administered this drug throughout organogenesis showed adverse effects on development at maternal exposures less than those observed clinically (increased incidences of fetal abnormalities, increased embryofetal and offspring mortality, decreased fetal body weight). High doses were associated with maternal toxicity. In rats, increases in skeletal variations occurred at mid and high doses and reduced fetal body weight at the highest dose tested (a dose that was associated with maternal toxicity). No adverse effects on embryofetal development were observed with plasma exposures approximately 10 times the expected maximum recommended human dose. Administration to rats throughout pregnancy and lactation resulted in an increase in still birth and neonatal mortality at the highest dose tested which was also associated with maternal toxicity and delayed parturition. 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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Reyvow Breastfeeding Warnings
Following administration to lactating rats, this drug was found in rat milk at levels approximately 3 times those 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 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.
See references
