Infant Cough and Cold Medications

By Trevor Shewfelt, Pharmacist at the Dauphin Clinic Pharmacy

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The information in this article is intended as a helpful guide only. It is not intended to be used as a substitute for professional advice. If you have any questions about your medications and what is right for you see your doctor, pharmacist or other health care professional.

I have kids. Emily is seven and Eric is four. I am sure this won’t be the first or last time Eric thinks this, but apparently I favor his sister. If both my kids got a cough at the same time, I can help seven year old Emily, but I have to let four year old Eric suffer. You will now notice most over the counter cough and cold medications say don’t used in children under 6 years old. Why is this?

Back in January 2008 the Food and Drug Administration (FDA) in the US said all cough and cold medications should be avoided in children under the age of two. A little later Health Canada made a similar recommendation. In October 2008 in the US manufacturers warnings said not to give cough and cold products to children under four and to not give any children antihistamines just to make them sleepy. Canadian labeling changes came into effect in the fall of 2009 and now say most cough and cold medications shouldn’t be given to children under 6.

So why all the fuss? Yes, my mom gave me Neo-Citran because it had an antihistamine in it which would make me sleepy. Yes, I gave my own children cough and cold medication before the age of four. The fuss boils down to safety and efficacy. For every medication we should ask: Is it Safe? Is it Effective? And what is the risk versus benefit of using it? For infant cough and cold medications, let’s start with are they safe?

It is safe to give over the counter cough and cold medication to infants and toddlers MOST of the time. The problem is the dose. There have been documented cases of parents giving their children the wrong dose. “No problem,” you say, “I can read. I’ll give my child the right dose!” Well, between 1969 and 2006 in the US there were 69 deaths in children from antihistamines and 54 deaths in children due to decongestants. Now, these are small numbers. Even if we assume the actual number of deaths are much higher than those reported, and we stipulate that the number of injuries is not counted at all, not many children were harmed. When you consider the probable millions of doses of cough and cold medications given to children over the 37 years considered, cough and cold medications didn’t kill many children. But, they did kill and injure some children, so the risk isn’t zero.

So why do well meaning parents give the wrong dose to their kids? There are four main reasons: multiple ingredients, wrong formulations, kitchen spoons and small margin of error. Multiple ingredients means many cough and cold medications have more than one ingredient. For example let’s assume you bought a cough syrup, a anti-sneezing pill and Tylenol cold for your child. There is a decongestant in all three of those products. If you were unaware of this you could give your child 3 times the recommended dose of decongestant. That dose could cause a rapid heart rate or theoretically it could cause death. Wrong formulation means some products come in different strengths. Acetaminophen (or Tylenol) comes in 80 mg/ml and 160mg/5ml liquid. If a parent uses the 80mg/ml liquid when they meant to use the 160mg/5ml and gives their child 1 tsp (5 mL), the child get 400 mg (not 160 mg) of acetaminophen which is 2.5 times too much. Kitchen spoons means don’t use your kitchen spoons to measure your child’s medication. When a pharmacist says 1 teaspoon, we mean 5 mL. A kitchen teaspoon is not calibrated. Kitchen teaspoons vary from 2.5 to 10 mL. So if you use your kitchen teaspoon and I say give the child 1 teaspoon of medication you could be giving them anywhere from ½ the dose to twice the dose you were supposed to. Small margin of error refers to the fact children are small. Since children are small, their medication doses are small. Unfortunately that means even small errors in measuring a child’s medication can be harmful.

So we’ve seen that cough and cold medications have a small but real chance of harming children. So do cough and cold medications actually work? Are they effective? Probably not. What we need is to run some experiments where we give possibly dangerous chemicals to a bunch of babies….Any volunteers? For good ethical reasons, we don’t test cough/cold meds on babies. Even if we did, it is hard to ask them if they are feeling better or not. Cold medications have been tested on teenagers and adults. There is only a little proof that they improve symptoms like reducing the amount of cough and sneezing in teens and adults. If we assume infants and toddlers are just “little adults”, cold meds should help them a little too, right? The problem is infants and toddlers aren’t just little adults. Their lungs and immune systems are different. So we now think cold meds may not be effective in infants and toddlers at all (remember we can’t actually test meds on them). If cough and cold medications probably don’t help my child’s symptoms, and…If I give them the wrong amount I may harm them…Are Cough and Cold Medications in infants and toddlers worth the Risk? Probably not. And that is why Health Canada says I can treat my 7 year old but not my 4 year old.

As always if you have any questions or concerns about these or other products, ask your pharmacist.