Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There is no available data on use in pregnant women to inform a drug-associated risk of adverse developmental outcomes; this drug is known to reduce serum vitamin A levels and vitamin A is essential for normal embryofetal development

Comments:
-It is unknown what the expected maternal effects of reduced serum transthyretin (TTR) and vitamin A supplementation will have on the fetus.

Subcutaneous administration to male and female mice every other day prior to and during mating and continuing in females throughout the period of organogenesis produced no adverse effects on embryofetal development. In rabbits, premature delivery and reduced fetal body weight were observed at the highest dose tested, which was also associated with maternal toxicity. Vitamin A supplementation is recommended in patients taking this drug; however, excessive levels of Vitamin A are associated with adverse developmental effects. 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: 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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