FDA Warns About Risk of Infant Overdose with Liquid Vitamin D Due to Errors

Federal drug safety officials are warning parents that some vitamin D supplements for infants currently on the market carry the risk of an accidental vitamin D overdose. 

The FDA issued a vitamin D infant overdose risk alert this week to parents, warning that the droppers supplied with some supplements could hold enough vitamin D to cause parents to make a dangerous medication error. In addition to the warning, the FDA is sending out letters to the vitamin supplement industry recommending that the size of droppers supplied with vitamin D supplements be limited to holding the maximum safe dose for infants.

Many parents who breast feed or partially breast feed their infants give them vitamin D supplements, which help the baby absorb calcium and helps in the development of strong bones. But too much vitamin D can lead to a vitamin D overdose, which can cause nausea, vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, fatigue and may also lead to kidney damage.

The American Academy of Pediatrics has set a maximum dose recommendation of 400 International Units (IU) of vitamin D for infants being breast fed. However, the FDA warns that some of the droppers provided with the supplements can hold much greater amounts and could lead to a medication mistake.

The FDA recommended that the industry set the maximum size of the droppers to 400 IU, but in the interim, supplements may have droppers that contain more. The FDA made the following recommendations to parents to avoid a vitamin D overdose:

• Use only droppers that came with the vitamin D supplement
• Make sure your infant does not receive more than 400 IU of vitamin D per day
• Ensure the dropper is properly marked and that the units of measure are clear and easy to understand
• If a child is fully or partially fed with infant formula, check with a health care professional before giving them vitamin D supplements
• Keep vitamin D supplements with their original package so you and other caregivers can carefully follow the instructions

The FDA notes that the easiest way for parents to ensure their child gets the safe amount of vitamin D is to always consult a health care professional before starting supplements, and only using vitamin D supplements that come with droppers that contain no more than 400 IU.