FDA Warns of Liquid Vitamin D Dropper Overdose Risk in Infants

June 17, 2010

The U.S. Food and Drug Administration (FDA) has issued a warning to parents and caregivers that some droppers sold with liquid Vitamin D supplement products could allow dosage errors, resulting in a dangerous overdose to infants.

Some droppers on the market can hold a significantly greater amount of Vitamin D than an infant should receive. The FDA fears that this may lead parents to give an unsafe amount of Vitamin D inadvertently or mistakenly to their infant.

Physicians often recommend that parents give infants a Vitamin D supplement because it promotes calcium absorption and helps the development of strong bones. In 2008 the American Academy of Pediatrics (AAP) recommended that all breast-fed and partially breast-fed infants (beginning in the first 2 months after birth) consume 400 IU/day of Vitamin D. Deficiency of Vitamin D in infants can cause thin, soft and misshapen bones.

"It is important that infants not get more than the recommended daily amount of vitamin D," says Linda M. Katz, M.D., M.P.H., interim chief medical officer in FDA’s Center for Food Safety and Applied Nutrition. "Parents and caregivers should only use the dropper that comes with the vitamin D supplement purchased."

Vitamin D overdose can cause nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, headache and fatigue, as well as the more serious consequences like coma, kidney damage and heart rhythm abnormalities. It can cause calcium levels in the blood, called hypercalcemia, which may damage soft tissues such as kidneys, blood vessels, heart, lungs and skin.

“To reduce the likelihood of dosing errors, FDA recommends that 400 units be clearly and accurately marked on the dropper accompanying your product,” the FDA advised industry manufacturers in a letter. “In addition, for products intended for infants, FDA recommends that the dropper hold no more than 400 units.”

The FDA produced a consumer update titled “Infant Overdose Risk with Liquid Vitamin D” which recommends the following:

• Ensure that your infant does not receive more than 400 international units (IUs) of vitamin D a day, which is the daily dose of vitamin D supplement that the American Academy of Pediatrics recommends for breast-fed and partially breast-fed infants.
• Keep the vitamin D supplement product with its original package so that you and other caregivers can follow the instructions. Follow these instructions carefully so that you use the dropper correctly and give the right dose.
• Use only the dropper that comes with the product; it is manufactured specifically for that product. Do not use a dropper from another 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 the infant.
• If your infant is being fully or partially fed with infant formula, check with your pediatrician or other health care professional before giving the child vitamin D supplements.