Amid the annual sniffling and sneezing of the cold and flu
season, the U.S. Food and Drug Administration (FDA) finally issued
its timely statement about the safety and effectiveness of cough
and cold medicines for young kids. After a year of questions and
debate from all angles, the government is affirming that these
over-the-counter (OTC) remedies should
be used for children under 2 - they're
safe and do
work for babies and toddlers.
What the federal agency
said yet is whether these medications are OK or even effective in
older kids (ages 2 to 11) either - they're still reviewing the
research. But this latest FDA warning - that these medications can
have "serious and potentially life-threatening side
effects" in babies and toddlers - echoes previous efforts to
get the important word out about the risks of using these
medications in the littlest of kids.
In January 2007, the Centers for Disease Control and Prevention
(CDC) warned parents not to use the meds in infants and toddlers
after three babies' deaths in 2005 were linked to the toxic
effects of cough and cold medicines, which sent more than 1,500
kids under 2 to emergency rooms in 2004 and 2005.
In October 2007, drug-makers took the proactive step of
voluntarily yanking 14 popular cough and cold medicines labeled for
babies and toddlers from the market. Although the FDA hadn't
made its official call yet, the manufacturers erred on the side of
caution to prevent parents from misusing and accidentally
overdosing their young tots on these OTC drugs stocked in millions
of medicine cabinets.
A Closer Look at the Concerns
Although the cough and cold medications for kids under 2
targeted by the FDA ruling are no longer on the shelves, they may
still be found in many households. These "infant"
products' titles alone are extremely misleading because they
imply that they're tailored to and, therefore, safe for babies.
So, many parents may mistakenly assume that if "infant"
or "toddler" is in the title of an OTC cough or cold
drug, it must be OK for really young children. Not so.
Despite the medications' names, there was actually never an
FDA-approved dosage of OTC cough and cold remedies for kids under
age 2. That's why the dosing tables on the labels say only
"ask a doctor" for kids under 2.
Unfortunately, the message to seek medical advice before giving
the medications can be easily overlooked or downplayed as
well-meaning parents scramble to give their child something to make
it all better - an honest mistake that can prove deadly.
And now, health officials agree that it's
OK to give these meds to babies and toddlers, no matter what the
old labels say. With risks like convulsions, increased heart rates,
and lowered levels of consciousness, potentially fatal overdoses of
cough and cold medicines can happen in babies and toddlers when
- more than the amount recommended for their age and
- doses of medication too often
- more than one cough and cold medication - OTC and/or
prescription - with the same ingredient(s)
In one fell swoop, these OTC drugs may deliver multiple strong
medicines like cough suppressants, decongestants, expectorants, and
antihistamines, as well as pain relievers and fever-reducers such
as ibuprofen and acetaminophen. Decongestants, for one, can cause
hallucinations, irritability, and irregular heartbeat in babies and
To find out just how many kids, young and old, are having
dangerous reactions to these cough and cold remedies, CDC
researchers looked at data from 63 emergency departments in the
United States throughout 2004 and 2005. What they found: More than
7,000 kids 12 and younger were treated for "adverse drug
events attributable to cough and cold medications," says a new
report published online in
. Toddlers and preschoolers, ages 2 to 5, accounted for most (64%)
of those ER trips. And two thirds of the visits were because of
"unsupervised ingestions" - in other words, tots (almost
80% of whom were, again, 2 to 5) had gotten hold of these
potentially toxic drugs and taken them without their parents'
What This Means to You
When your baby's barking like a seal or struggling to
breathe through a sore, stuffed-up nose, it's tempting to try
one of the many cough and cold medicines that
to be intended for the littlest sick kids.
Although medication might seem like a quick fix when your little
one's fighting a cold, the flu, or some other upper respiratory
bug, riding it out is all you can really do. The viruses that
usually cause the occasional sneezes, sniffles, and coughs
can't be treated with antibiotics.
All that kids usually need when they're on the mend is a
little time, rest, and plenty of fluids. Plus, you can put some
simple and safe symptom-fighting weapons to use like:
- a cool-mist humidifier
- petroleum jelly under the nose
- saline (or saltwater) drops for the nostrils
- a bulb syringe to suck out mucus
Of course, call your doctor if you think your kid's sickness
isn't getting any better or is getting worse. In the meantime,
though, don't use any of the cough and cold remedies for kids
under 2 listed below. And before giving medication of
kind to a child at
age, always make sure to:
- Carefully read the labels.
- Use medicines only as directed.
- Call the doctor if a dosage isn't listed or you're
unsure about how much to give.
- Store medications safely out of children's reach.
- Use only the measuring device (dropper, cup, or spoon) that
comes with the medication
one that's available at the pharmacy with the exact dosing
measurements indicated on the medication's label.
give medicine in household spoons or other kitchen utensils.
give adult medications to children.
give OTC cough and cold medications along with prescription or
other OTC drugs without first talking to your doctor.
And if you have any of the following infant and toddler cough
and cold medications in your home that were taken off the market in
the fall of 2007, throw them away today:
Decongestant Plus Cough Infant Drops
Decongestant Infant Drops
- Little Colds
Decongestant Plus Cough
- Little Colds
Multi-Symptom Cold Formula
Infant Drops Decongestant (containing pseudoephedrine)
Infant Drops Decongestant & Cough (containing
Infant Dropper Decongestant (containing phenylephrine)
Infant Dropper Long-Acting Cough
Infant Dropper Decongestant & Cough (containing
Infant Cough DM Drops
Infant & Toddler Thin Strips
Infant & Toddler Thin Strips
Decongestant Plus Cough
Concentrated Infants' Drops Plus Cold
Concentrated Infants' Drops Plus Cold & Cough
It's also wise to give your doctor a call before giving tots
2 any cough and cold remedy, considering the jury's still out
on whether they're safe - or even work - for older kids
Steven Dowshen, MD
Date reviewed: January 2008
Note: All information is for educational purposes only. For specific medical advice,
diagnoses, and treatment, consult your doctor.
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