October 21, 2008
Momma Don’t Take my Cold Medicine Away!
Momma Don’t Take my Cold Medicine Away!
When I first heard the FDA was against cough and cold medicine for children under 2 years old, I was so grateful that my daughter at the time was 4. She is now five and there is talk about banning all cough and cold medicine for children under 6 years old. Now they have my attention.
An advisory committee has recommended that the FDA ban all cough medicine for children under the age of 6. The FDA announced October 2008, they would collect more data to decide if they are safe and effective for children. Drug companies have gone ahead and changed the packaging of children’s cough and cold to read, ”Consult a Doctor under age 4.” So what’s the scoop?
Why did they call for the halt of children’s cough medicine?
1) Efficacy, which means, “Does it work?” Several studies showed that the medicines worked no better than placebo. When these drugs were approved 30 years ago they were not studied in children so there are, in fact, very few studies showing that they actually do work in children.
2) Safety is the major reason why they want to pull the medicines. Too many children were showing up to the ED with heart arrhythmias, seizures and breathing problems after using cough and cold medicines. It has been reported about 7000 children a year end up in the ED after taking these meds. There are even 3 deaths a year attributed to cold medicines. Between 1969 and 2006 there have been 54 deaths from decongestants and 69 deaths associated from antihistamines.
Why are the drugs unsafe?
The drugs themselves at the correct dose are not particularly unsafe but the vast majority of hostpital visits were due to accidental overdose of the medications, which is far easier than you may think.
How do you OD your child on cough medicine?
1) Children’s doses are based on weight and a very small change can have a very big affect. Parents easily confuse doses, teaspoons to tablespoons. The FDA is recommending that parents only use the cups that come with the medicine as opposed to spoons that you may have at home.
2) Many of the medications have multiple drugs in them so parents would give a double dose and not even realize it. You must read the label and look for the active ingredient. For instance Tylenol cold has Tylenol to reduce fever and a decongestant. Some will have decongestant and cough reliever. Even with my MD, all of the doses can be very confusing so IT IS CRITICAL TO READ THE ACTIVE INGREDIENTS!
3) Timing. I know when I was up giving my children medicine in the middle of the night I would sometimes forget what time I gave it. It all becomes a blur and I would be in a fog the next day. Did I give that at 3 in the morning or midnight? Here is it 6 am the child still has symptoms and I want some relief for both of us. I can see how easily, especially if these medicines don’t work like the studies say, how a parent would be tempted to give more, which causes an accidental overdose.
What can we safely do?
Most important is prevention. I saw a dramatic decrease in the colds and coughs in my house when I enforced hand washing, not just before meals but also upon entering the house. My husband was one of the biggest culprits of introducing germs into the house. He has washed his hands all day but having him wash on arrival really helped our house stay healthy.
I also give the kids 500mg of Vitamin C. The studies are not that compelling that it works but I have seen enough benefit in my house to keep using it.
If they do get sick, then you can use vaporizers, normal saline to flush the nose and suction if they need it. Tylenol alone can provide relief if they have a fever. (Check the dose carefully). Rest and fluids, including good ole chicken soup are often the best remedy.
Wash those hands and stay healthy,
Dr. Deb

carolynne said,
March 18, 2011 @ 2:10 am
hi there, so my situation is my entire family is sick. I took the kids to see the physician and my teens were all given a prescription for lung infections and sinus. My 2 yr 9 month old(almost 3) was just beginning to cough and show symptoms like the older siblings. My physician said for her to use Tylenol cold. I was suprised because of all the advertisement not to use . He said 2 1/2 ml was fine. I tried to ask the pharmacy but they said they would not comment . So now what? If I wait I run the risk of her being as sick as my older children and if I give it to her I feel like Im horrible,so if your physician prescribes it and gives the right amount what to do? Just to add all my older children took cold meds from banies, because it was allowed then.
drouseraines said,
March 18, 2011 @ 5:07 am
You know Carolynne, that is a great question and really a tough one to answer. Let me give you a little information.
Tylenol and “Cold” medicine given in the correct doses are not harmful to children. I can’t comment that 2.5 ml is correct because I would have to look at the bottle from which you are giving the medicine.
Here in lies the problem is. There are so many “Cold” medicines with a differing drugs and doses that it is very confusing for adults, (especially sleep deprived, fumbling in the middle of the night from sick kids- parents.) Many parents don’t know the generic name of Tylenol is Acetaminophen so they give double doses. As a physician parent, I have even been confused. If I start with just Tylenol but then they get stuffy and I want to add a cold medicine, what happens if all I have is Tylenol cold? “What time did I give that Tylenol?” Is it too early to give a dose of Tylenol Cold? It can all become a blur.
Tylenol is VERY toxic at high doses causing irreversible liver damage and death. That is one of the reason they have pulled these drugs for young children whose small bodies don’t need a lot to become toxic. All of the new combinations of medicines made for too many emergency room visits from accidental overdose. Only you can make the decision about what to give your child.