Skip to Content

Calcitriol Pregnancy and Breastfeeding Warnings

Calcitriol is also known as: Calcijex, Rocaltrol

Calcitriol Pregnancy Warnings

Nonteratogenic effects noted in animals receiving calcitriol at doses approximately 6 times the maximum recommended for human use included increased maternal fatality, decreased fetal body weight, and a reduced number of newborns surviving up to 24 hours. A woman with hypoparathyroidism was successfully treated with calcitriol during pregnancy. Calcitriol was given throughout the pregnancy at a dose of 1.5 to 3 mcg per day without fetal adverse effects. Increases in dose were necessary during the last trimester to combat hypocalcemia, muscle cramps, and paresthesias. Mild hypercalcemia returning to normal by day 3 of life was reported in a neonate of a woman administered 17 mcg to 36 mcg of calcitriol daily (17 to 36 times the maximum recommended dose) during pregnancy. 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.

Calcitriol has been assigned to pregnancy category C by the FDA. Animal studies have shown calcitriol to be teratogenic, resulting in external and skeletal abnormalities, when used at doses 4 to 15 times the recommended human dose. There are no controlled data in human pregnancy. Calcitriol should be used during pregnancy only when benefit outweighs the risk.

See references

Calcitriol Breastfeeding Warnings

There are no data on the excretion of calcitriol into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue calcitriol, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. Taussig HB "Possible injury to the cardiovascular system from vitamin D." Ann Intern Med 65 (1966): 1195-200
  2. Goodenday LS, Gordon GS "No risk from vitamin D in pregnancy." Ann Intern Med 75 (1971): 807-8
  3. Sadeghi-Nejad A, Wolfsdorf JI, Senior B "Hypoparathyroidism and pregnancy. Treatment with calcitriol." JAMA 243 (1980): 254-5
  4. Rowe RD, Cooke RE "Vitamin D and craniofacial and dental anomalies of supravalvular stenosis." Pediatrics 43 (1969): 1-2
  5. "Product Information. Rocaltrol (calcitriol)." Roche Laboratories, Nutley, NJ.

References for breastfeeding information

  1. "Product Information. Rocaltrol (calcitriol)." Roche Laboratories, Nutley, NJ.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.