Animal studies of oral administration of 10 to 30% daily caloric intake (DCI) of this product during organogenesis showed reduced body weight gain which was considered specific to taste aversion related decreases in food consumption. The no adverse effect level (NOAEL) for the maternal toxicity was 10% of DCI; at approximately 35% DCI increased skeletal malformations, decreased litter weights, and reduced number of viable litters were seen; these were associated with maternal reduced body weight gains. At 50% DCI reduced birthweights and delayed sexual maturation of pups was seen but was considered secondary to reduced maternal body weight gain. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

Report pregnancies to Ultragenyx Pharmaceutical Inc. at 1-888-756-8657.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Animal studies showed reduced body weight gain which was considered specific to taste aversion related decreases in food consumption and is not considered relevant in the intended populations.

See references

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

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.
-Fatty acids and medium chain triglycerides are normal breastmilk components which vary within feedings, lactation stages, maternal genetics, environment, and diet.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references