Ergocalciferol Pregnancy Warnings
Safety has not been established during pregnancy. Use only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: Exempt
US FDA pregnancy category: C
Comments:
-Avoid use of vitamin D in excess of the recommended dietary allowance.
-The safety of vitamin D doses in excess of 400 international units has not been established.
Animal studies have shown fetal abnormalities associated with hypervitaminosis D, similar to supravalvular aortic stenosis syndrome. There are no controlled data in human pregnancy.
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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references