FDA Issues Recommendations for Parents, Industry on Infant Vitamin D Supplements

Products Pose Potential Overdose Risk

June 22, 2010 04:50 pm News Staff

The FDA is warning consumers(www.fda.gov) about the risk of overdosing infants with liquid vitamin D supplements.

The FDA is warning consumers about the potential for overdosing infants with vitamin D liquid drops.

In 2008, the American Academy of Pediatrics doubled the recommended daily intake of vitamin D(pediatrics.aappublications.org) for infants and children from 200 international units, or IU, a day to 400 IU.

But Linda Katz, M.D., M.P.H., interim chief medical officer in the agency's Center for Food Safety and Applied Nutrition, said in a June 15 teleconference that some liquid vitamin D products come with droppers that can hold significantly more than the recommended amount of liquid vitamin D.

In a June 15 safety alert(www.fda.gov), the FDA recommended that 400 units be clearly and accurately marked on droppers packaged with vitamin D supplements. It also recommended that products intended specifically for infants have droppers that hold no more than 400 units.

Vitamin D promotes calcium absorption and plays a key role in the development of strong bones. However, Katz said excessive vitamin D can cause nausea, vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, fatigue, and kidney damage.

The agency said other potential serious consequences of overdose may include cardiac arrhythmias, osteomalacia and hypercalcemia, which can lead to soft-tissue deposition of calcium, resulting in other associated problems, such as hypertension.

The agency issued a number of recommendations aimed at parents and other caregivers.

  • Ensure that your infant does not receive more than 400 IU of vitamin D a day.
  • Keep the vitamin D supplement product with its original package so that you and other caregivers can follow the dosing instructions. Follow these instructions carefully and give the correct dose.
  • Use only the dropper that comes with the product because it is manufactured specifically for that product.
  • Ensure the dropper is marked so that the units of measure are clear and easy to understand. Also make sure that the units of measure correspond to those mentioned in the instructions.
  • If you cannot clearly determine the dose of vitamin D delivered by the dropper, talk to a health care professional before giving the supplement to your infant.
  • If your infant is being fully or partially fed with infant formula, check with your physician before giving the child vitamin D supplements.

Physicians and consumers are encouraged to report adverse events or side effects related to the use of vitamin D liquid products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program(www.fda.gov).

Although vitamin D overdose is a serious issue, a study(pediatrics.aappublications.org) published in the April issue of Pediatrics found that the vast majority of U.S. infants don't receive enough vitamin D.

Researchers found that no more than 13 percent of infants who were strictly breastfed met either a 2003 recommendation for 200 IU of vitamin D or the 2008 recommendation of 400 IU. As many as 35 percent of infants who received breast milk and formula met the 2003 recommendation, but only 9 percent to 14 percent met the 2008 recommendation.

Of infants who received only formula, 81 percent to 98 percent met the 2003 recommendation, but less than 40 percent met the 2008 recommendation.

Researchers concluded that physicians should encourage parents of infants who either are exclusively breastfed or who consume less than one liter of formula a day to give their infants an oral vitamin D supplement.