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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 never be used for children under 2 - they're not safe and do not work for babies and toddlers.

What the federal agency hasn't 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 never 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 they're given:

• more than the amount recommended for their age and weight
• 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 toddlers.

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 Pediatrics . 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' permission.

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 seem 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 any kind to a child at any 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 or one that's available at the pharmacy with the exact dosing measurements indicated on the medication's label. Never give medicine in household spoons or other kitchen utensils.
• Never give adult medications to children.
• Never 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:

It's also wise to give your doctor a call before giving tots over 2 any cough and cold remedy, considering the jury's still out on whether they're safe - or even work - for older kids either.

Reviewed by: Steven Dowshen, MD
Date reviewed: January 2008