Rayaldee Pregnancy Warnings
Calcifediol has been assigned to pregnancy category C. Calcifediol has been shown to be teratogenic, resulting in external and skeletal abnormalities, when used at doses of 6 to 12 times the dose recommended for human use. There are no controlled data in human pregnancy. Calcifediol should only be used during pregnancy when benefit outweighs the risk.
Earlier literature expressed concerns over the development of supravalvular aortic stenosis, craniofacial abnormalities, and dental abnormalities in infants and children with idiopathic hypercalcemia. Whether or not prenatal factors predisposed these children to the development of hypercalcemia is not known.
Fifteen hypoparathyroid women receiving 50,000 to 250,000 Intl units of vitamin D2 experienced 27 uneventful births. No cardiovascular or craniofacial abnormalities were reported.
See references