from today's MEDwatch report....
Vitamin D Supplement Products: Medication Use Error
Audience: Pediatrics, Family Practice, Consumer
ISSUE: Some liquid Vitamin D supplement products are sold with droppers
that could allow parents to accidentally give harmful amounts of Vitamin D to
their infant. Excessive amounts of Vitamin D can be harmful to infants,
and may be characterized by nausea and vomiting, loss of appetite, excessive
thirst, frequent urination, constipation, abdominal pain, muscle weakness,
muscle and joint aches, confusion, and fatigue, as well as more serious
consequences like kidney damage.
BACKGROUND: The American Academy of Pediatrics has recommended a dose of
400 International Units (IU) of Vitamin D Supplement per day to breast-fed
and partially breast-fed infants (AAP Pediatric Nutrition Handbook, 6th
edition, p.466).
RECOMMENDATION: The easiest way to insure that an infant will not get more
than the recommended dose is to use a product supplied with a dropper that
will give no more than 400 IU per dose. If a caregiver cannot clearly
determine the dose of Vitamin D that should be given to an infant or has any
other questions, FDA recommends consulting with a healthcare provider before
giving any of these products to an infant.
Healthcare professionals and patients are encouraged to report adverse
events or side effects related to the use of these products to the FDA's
MedWatch Safety Information and Adverse Event Reporting Program:
* Online: _www.fda.gov/MedWatch/report.htm_
(http://www.fda.gov/MedWatch/report.htm)
* Phone: 1-800-332-1088
* Mail: return the postage-paid FDA form 3500, which may be
downloaded from the MedWatch "_Download Forms_
(http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm) " page, to address on the
pre-addressed form
* Fax: 1-800-FDA-0178
Read the complete safety alert, including links to the FDA Note to
Correspondents and the FDA Consumer Update, at:
_http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe
dicalProducts/ucm215523.htm_
(http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215523.htm)
____________________________________
You are encouraged to report all serious adverse events and product
quality problems to FDA MedWatch at _www.fda.gov/medwatch/report.htm_
(http://www.fda.gov/medwatch/report.htm)
Peace,
Judy
Judy LeVan Fram, PT, IBCLC, LLLL
Brooklyn, NY, USA
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