Safety has not been established during pregnancy

US FDA pregnancy category: Not assigned

Risk Summary: There are no adequate human or animal data on the developmental risks associated with the use of this drug in pregnancy.

Comments:
-Some authorities advise that use during pregnancy should be avoided as a precautionary measure.
-A pregnancy registry has been established; patients are encouraged to register in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org.

Animal studies on developmental risks have not been reported. Animal studies have not shown harmful effects to reproductive toxicity in the absence of paternal or maternal toxicity. 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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A lactation study in rats with radiolabeled dexfenfluramine has shown excretion of dexfenfluramine and nordexfenfluramine into rat milk.

Safety has not been established

Excreted into human milk: Unknown
Excreted into animal milk: Yes (metabolites)

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Some authorities advise against use while breastfeeding as a risk to the breastfed infant cannot be ruled out.

See references