June 15, 2010 -- The FDA is warning parents and caregivers of infants that some liquid vitamin D supplement products sold with droppers could allow excessive doses to be given to babies, which could be harmful.
The FDA says some droppers that come with the vitamin D liquid could hold more than the 400 international units (IU) a day recommended by the American Academy of Pediatrics.
"It is important that infants not get more than the recommended daily amount of vitamin D," Linda M. Katz, MD, MPH, of the FDA, says in a news release. "Parents and caregivers should only use the dropper that comes with the vitamin supplement purchased."
Excessive vitamin D can cause nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue and even cause serious damage to kidneys, the FDA says.
Vitamin D in proper doses is necessary for infant development, promoting calcium absorption in the gut and strong bone development. Vitamin D supplements are recommended for some infants, especially those who are breastfed, because deficiency can lead to bone problems, such as thinning, soft, and misshapen bones such as seen in the condition known as rickets.
The FDA told manufacturers of liquid vitamin D supplements that droppers accompanying the products should be clearly and accurately marked for 400 IU. For products meant for infants, droppers should hold no more than 400 IU, the FDA said.
Joshua M. Sharfstein, MD, principal deputy commissioner of FDA, said in a letter to manufacturers that the agency has learned in the past several months that there has been an increase in the number of liquid vitamin D supplements and called on the industry to "provide the necessary safeguards to ensure that infants using these products" to prevent unsafe amounts from being given.
The FDA issued the following list of recommendations:
Make sure your infant does not receive more than 400 IU of vitamin D daily.
Keep the supplement product with its original package so that instructions can be followed to the letter by parents and caregivers.
Use only the dropper that comes with the product and is manufactured just for the product. Do not use a dropper from another product.
Make sure the dropper is marked so that the units of measurement are clear and easy to understand. Make sure also that the units of measure correspond to those mentioned in the instructions.
Talk to a health care professional before giving an infant a supplement if you cannot clearly determine the dose of liquid the dropper will deliver.
If your infant is being fully or partially fed with infant formula, check with your pediatrician or other health professionals before giving your baby vitamin D supplements.
Always remember that any type of medication or dietary supplement can have adverse risks and must be taken according to the manufacturer's directions.
Siobhan DeLancey, a spokeswoman for the FDA, tells WebMD the agency has no list of companies that have "violative labeling" and that its alert is not an enforcement action but an advisory to the industry.
The letter, she says, was sent to industry trade groups such as the Council for Responsible Nutrition to make sure the word is spread to companies, as well as parents and caregivers.
Vitamin D is considered a dietary supplement, not a drug, and therefore FDA would have no comprehensive list of manufacturers, DeLancey.
"We just wanted to get the message down, just to make sure manufacturers know that there is a danger to over-supplementation," she says.