|Cold Medicines Dangerous for Infants
Over-the-counter cough and cold medications can be harmful
even deadly -- to very young children, U.S. government research
In 2005, three infants under the age of 6 months died from taking
such medications. And, from 2004 to 2005, more than 1,500 children
under the age of 2 were treated in emergency rooms for problems
related to taking such medications, according to a report released
"Cough and cold medicines can be harmful, and even fatal, and
should be used with caution in children under 2 years of age,"
said study author Dr. Adam Cohen, an officer in the Epidemic
Intelligence Service at the U.S. Centers for Disease Control and
Prevention. "They are drugs, so they have risks as well as benefits."
The study appears in the Jan. 12 issue of the Morbidity and
Mortality Weekly Report, a publication of the CDC.
The U.S. Food and Drug Administration has only approved the
use of over-the-counter cough and cold medicines in children
over the age of 2. In children younger than 2, studies have concluded
that such medications are no more effective than a placebo.
As a result, appropriate dosing is not known.
"Cold and cough medications, especially medications containing
pseudoephedrine [a nasal decongestant], have never been shown
to have any beneficial effect on children less than 2 years of age,
yet they clearly can have significant harmful effects," said Dr. Michael
Marcus, director of pediatric pulmonology, allergy and immunology
at the Maimonides Infants & Children's Hospital in New York City.
"There are no studies to support the use of cold medicine in infants,
" said Dr. Gwen Wurm, director of community pediatrics at the
University of Miami Miller School of Medicine. "The thing to keep
in mind is that colds go away. Kids might benefit from a humidifier
by the bed and saline nose drops, but this kind of loving care is all
most kids need."
Various professional groups, including the American Academy of
Pediatrics and the American College of Chest Physicians, have
issued guidelines recommending caution when using these medications
in young children.
In June 2006, the FDA took action to stop the manufacture of
medications containing carbinoxamine (an antihistamine) which
were inappropriately labeled for use in infants and young children.
Manufacturers were required to stop production by Sept. 6, 2006,
but some products might still be in distribution.
The Combat Methamphetamine Epidemic Act of 2006, passed last
March, banned over-the-counter (though not behind-the-counter)
sales of products containing pseudoephedrine. As a result, many
companies have taken this ingredient out of their products.
But products which might be harmful to young children are still
available, so officials at the CDC and the National Association
of Medical Examiners (NAME) investigated deaths of children
under the age of 1 that were associated with cough and cold medicines.
The three infants who died ranged in age from 1 to 6 months;
two were male and all three were found dead in their homes.
Autopsy and medication investigation records revealed that cough
and cold medications were responsible for all three deaths. All three
babies had high levels of pseudoephedrine, ranging from nine to 14
times the levels expected from recommended doses for children aged
2 to 12. One of the infants had received both a prescription and an
over-the-counter cough and cold medicine at the same time, both
of which contained pseudoephedrine.
Two of the children had taken prescription medications containing
carbinoxamine, although there were no detectable blood levels of
the substance. Two of the infants had detectable blood levels of
dextromethorphan (a cough suppressant) and acetaminophen
(a fever-reducer and analgesic).
"Parents should absolutely avoid these medications unless they are
being supervised by a physician," Marcus said. "Parents should
realize that non-prescription medications may contain similar products
to medications that the pediatrician is also prescribing, therefore,
they should let the pediatrician know all treatments the child is
receiving when discussing a child's treatment."
"Parents should never give medicine without consulting a health
care provider, even over-the-counter," Cohen added. "Many
over-the-counter medicines may be marketed for infants, and
there are no approved dosing recommendations from the FDA
for this age group. There's very little evidence that they help in
children under 2.