"The U.S. Food and Drug Administration and the U.S. Environmental Protection Agency today issued draft updated advice on fish consumption. The two agencies have concluded pregnant and breastfeeding women, those who might become pregnant, and young"...
Vitamin D administration from fortified foods, dietary supplements, self-administered and prescription drug sources should be evaluated. Therapeutic dosage should be readjusted as soon as there is clinical improvement. Dosage levels must be individualized and great care exercised to prevent serious toxic effects. IN VITAMIN D RESISTANT RICKETS THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. When high therapeutic doses are used progress should be followed with frequent blood calcium determinations.
Maintenance of a normal serum phosphorous level by dietary phosphate restriction and/or administration of aluminum gels as intestinal phosphate binders in those patients with hyperphosphatemia as frequently seen in renal osteodystrophy is essential to prevent metastatis calcification.
Adequate dietary calcium is necessary for clinical response to vitamin D therapy.
Protect from light.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate the drug's potential in these areas.
Pregnancy Category C
Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation. For the protection of the fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific, unique case outweigh the significant hazards involved. The safety in excess of 400 USP units of vitamin D daily during pregnancy has not been established.
Caution should be exercised when ergocalciferol (ergocalciferol) is administered to a nursing woman. In a mother given large doses of vitamin D, 25-hydroxycholecalciferol (ergocalciferol) appeared in the milk and caused hypercalcemia in her child. Monitoring of the infants serum calcium concentration is required in that case (Goldberg, 1972).
Pediatric doses must be individualized (see DOSAGE AND ADMINISTRATION).
Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Calciferol Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Weight Loss Wisdom
Get tips, recipes and inspiration.