In the news: Cough and cold medicines not for toddlers

By Kris Clouthier

Last month, my 18-month-old daughter had a cough and a fever. When I called her pediatrician, the nurse told me give to her an over-the-counter cough and cold medicine. When I asked her which drugs, exactly, I should look for on the package, she didn't know.

"Dimetapp's a good one," she said.

"Dimetapp?" I repeated.

"Yes, Dimetapp."

"Do you know how many different kinds of Dimetapp there are?" I asked.

She laughed. "Look for the purple box."

I didn't laugh. Instead, I asked her to find out the drug names and give me a call back, which she did.

At the time, the Centers for Disease Control (CDC) had not yet issued its warning that cough and cold medications can be dangerous -– and in rare cases deadly -– for infants and toddlers. The report, published in January, cites three infant deaths and 1,519 emergency room visits related to these medicines from 2004 to 2005. The CDC urges parents to give these medicines to children under age 2 only when following the precise instructions of a health care provider.

The three infants who died all had blood levels of pseudoephedrine, a decongestant, that were nine to 14 times the recommended dosage for ages 2 to 12 years. Here are some highlights from the article, which appeared in Morbidity and Mortality Weekly Report:

• There are no Food and Drug Administration (FDA) approved dosage recommendations for the use of these medications in children under age 2. It's unknown what dosages will cause illness or death in this age group.

• Clinical studies have shown that, in kids under age 2, cough and cold medications are no more effective than a placebo in treating upper respiratory infections.

• The American Academy of Pediatrics sounded the alarm on this issue 10 years ago, urging health care providers to tell parents that these medicines will not suppress a cough and carry a risk of side effects and overdose.

• In 2006, the American College of Chest Physicians issued clinical guidelines "advising health care providers to refrain from recommending cough suppressants and other over-the-counter (OTC) medications to young children because of the associated morbidity and mortality."

According to the CDC report, I was smart to ask for exact drug names. In 2006, the FDA stopped the manufacture of one drug, carbinoxamine, which had been mislabeled for use in kids under age 2 despite safety concerns. Production stopped in September 2006, but some medicines containing carbinoxamine could still be on the shelf.

The experience with our pediatrician's office left my husband and I scratching our heads, wondering why these cough and cold medicines don't have the dosages for kids under age 2 on the package, along with the cartoon baby and the words "Infants and Toddlers." Now we know: There are no FDA-approved dosages. This makes me wonder why they're packaged for infants in toddlers in the first place, and how many parents guess the dose once they get the medicine home, rather than calling the doctor.

Now that I've read the CDC report, I think I owe our pediatrician a call. I'd like reassurance that her office will warn parents of the ineffectiveness of these medicines in small children, and the potential dangers.

Adverse events potentially related to use of cough/cold products in children younger than 2 years should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Kris Clouthier is stay-at-home mom to three and a freelance writer. She lives north of Boston.

Comments

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And by the way, we have taken him to the doctor and hospital twice when other symptoms appeared (fever, etc), and in both cases, they found nothing: "It's just a virus, let it run its course."

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I have to say that listening to this neverending cough is extremely hard on the parents. Sometimes he doesn't wake up from it even though he's sitting up. All I know is that when he's coughing so hard that he has to sit up while sleeping, I certainly am not sleeping. And this has been going on for months! (Specifically, since he started daycare, surprise, surprise.)

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I agree with yogurt at night, it's a great way to fight off cold.

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I am beginning to really lose all faith and credibility in the FDA. It seems to me that instead of focusing their efforts on protecting the general public they are in-turn being influenced by corporate agenda and special interest. I take everything they say with a grain of salt.

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The experience with our pediatrician's office left my husband and I scratching our heads, wondering why these cough and cold medicines don't have the dosages for kids under age 2 on the package,

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[Val Smith]

In 2000 my then 10 month old son suffered a stroke. We were later informed that it was due to the cough and cold meds he had been given over a few days while he was suffering a cold. We were tolf by the pediatrician to administer Robitussin and Two other cough meds.

The same pediatrician sent us home when we rushed our son to the doc because he would not move his left arm...she told us it was asleep. Fast forward through eight more visits to the office and 3 to the ER and we were told on that third ER visit 6 days after the initial symptoms of the stroke began that had suffered a STROKE!

Only after he lost the use of his left leg and MRI's were done were we taken seriously. Then we were asked millions of questions but the GOLD STANDARD was always..."Has he taken any meds lately"
Our answer, "Yes, cold medicine"

Thankfully he is 10 years old now and has some residual effects of the stroke but has surpassed what the doctors prognosis was at the time. He has a limp and some dexterity issues all on the left side of his body. However he is in 5th grade and reads at an 11th grade level. THANK GOD.

Sorry to say we learned the hard way and have had two babies since then and had two before him. I too HAVE LEARNED TO LET COUGHS AND COLDS RUN THEIR COURSE!!

VERY GOOD ARTICLE!!

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Side effects from the medications include agitation, restlessness,vomiting,increased heart rate. The babies tend to be more sensitive to medications than older children so be careful.

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[amy]

A great and important report - and something that had escaped my parenting-headline-skimming eyes. Thanks for detailing the guidelines.

[amy h.]

Kris,
I'm so glad you decided to write on this topic - good information! I had a very similar conversation when I called the nurse to ask about cough meds for my toddler - sounds like the AAP needs to make this a priority to get the word out to parents (and nursing staff!). Thanks for doing your part!
~Amy

[Claudette]

Good grief. And here I was so desperate to help my suffering 22-month old that I went out and got him the cough surpressant (Dimetapp DM for age 2 and up). I didn't give it to him because like you, I am getting mixed messages from various health care providers and associations (in Canada). Most say the same though: no meds to the under-2 and especially no DM, as it is ineffective anyway and can lead to things like overdose.

I have to say that listening to this neverending cough is extremely hard on the parents. Sometimes he doesn't wake up from it even though he's sitting up. All I know is that when he's coughing so hard that he has to sit up while sleeping, I certainly am not sleeping. And this has been going on for months! (Specifically, since he started daycare, surprise, surprise.)

We do all the recommended stuff that you can do to help him: firm pillow, elevate him when he slips back down, humidifier, and even this:

I do not give him milk or yoghurt before bed. I don't care who says that it does not increase the coughing, in my personal experience (me, the adult) I COUGH MORE IF I CONSUME YOGHURT AT NIGHT. So, he gets all the milk and yoghurt he wants till dinner time, then no more. Until the cough finally goes away.

And by the way, we have taken him to the doctor and hospital twice when other symptoms appeared (fever, etc), and in both cases, they found nothing: "It's just a virus, let it run its course."

So that's what we do....and have been doing for the past 5 months.

Very good article, and just in the nick of time!

Good luck with your little toddler.