Animal studies are not available. Maternal vitamin E concentrations at birth are 4 to 5 times higher than the newborns concentrations. Maternal supplementation of 15 to 30 mg vitamin E per day had no effect on maternal or term newborn vitamin E levels. A study of pregnancy outcomes of 82 mother-child pairs on high dose vitamin E (400 international units a day or more) showed no differences in live births, spontaneous abortions, elective abortions, stillbirths, gestational age at delivery, prematurity, or malformations compared to a control group, but the mean birth weight was lower in subjects versus controls (3173 versus 3417 grams, p = 0.0015) due to 2 infants with birth weights under 2500 grams.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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.

Use is considered acceptable

AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned

Comments:
-No maternal or fetal pregnancy complications have been seen in either deficient or excess vitamin E states.
-One study showed lower birth weights with high dose vitamin E supplementation during pregnancy; the lower weights were not considered clinically significant and may have been due to other factors.
-Well nourished patients should obtain adequate vitamin E from the diet; supplementation may be needed if dietary intake is poor.
-Vitamin E deficiency occurs in less than 10% of pregnancies.

See references

Use is considered acceptable.

Excreted into human milk: Yes

Comments:
-Vitamin E is a normal component of human milk
-Vitamin E levels may be lower in obese patients, smokers, and possibly preterm birth.
-Lactating patients may need vitamin E supplementation to reach the recommended daily intake; no information is available on higher daily dosages.

See references