The U.S. Food and Drug Administration issued
a Public Health Advisory for parents and caregivers, recommending that
over-the-counter (OTC) cough and cold products should not be used to treat
infants and children less than 2 years of age because serious and potentially
life-threatening side effects can occur from such use. OTC cough and cold
products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of
colds.
There are a wide variety of rare, serious
adverse events reported with cough and cold products. They include death,
convulsions, rapid heart rates, and decreased levels of consciousness.
"The FDA strongly recommends to parents
and caregivers that OTC cough and cold medicines not be used for children
younger than 2," said Charles Ganley, M.D.,
director of the FDA's Office of Nonprescription Products. "These
medicines, which treat symptoms and not the underlying condition, have not been
shown to be safe or effective in children under 2."
The announcement does not include the FDA's
final recommendation about use of OTC cough and cold medicines in children ages
2 to 11 years. The agency's review of data for 2-to-11-year-olds is continuing.
The FDA is committed to making a timely and comprehensive review of the safety
of OTC cough and cold medicines in children. The agency plans to issue its
recommendations on use of the products in children ages 2 to 11 years to the
public as soon as the review is complete.
Today's statement is based on the FDA's
review of data and discussion at a joint meeting of the Nonprescription Drugs
and Pediatric Advisory Committees on Oct. 18 and 19, 2007.
Pending completion of the FDA's ongoing
review, parents and caregivers that choose to use OTC cough and cold medicines
to children ages 2 to 11 years should:
·
Follow the dosing directions on the label of any
OTC medication,
·
Understand that these drugs will NOT cure or
shorten the duration of the common cold,
·
Check the "Drug Facts" label to learn
what active ingredients are in the products because many OTC cough and cold
products contain multiple active ingredients, and
·
Only use measuring spoons or cups that come with
the medicine or those made specially for measuring drugs.
The FDA recommends that anyone with questions
contact a physician, pharmacist or other health care professional to discuss
how to treat a child with a cough or cold.
For more information and the full list of the FDA's recommendations, visit:
Public Health Advisory: Nonprescription Cough
and Cold Medicine Use in Children
http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm
Questions and Answers for Consumers
http://www.fda.gov/consumer/updates/coughcold011708.html