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Kids & Cold Drugs: Questions, Answers

Experts Answer Your Questions About Children's Cough and Cold Medicines

But I gave these drugs to my children when they had colds and they worked. How can you say they don't?

Shannon:
Even though parents and some pediatricians believe these products work, science has proven that they don't. The studies show that these drugs don't work any better than inactive placebo. In fact, placebo worked better in one study. Treated children got better because colds get better over time.

Paul:
A lot of parents may have had the impression these drugs were working. But if they gave them a sweet, syrupy liquid, they might have done just as well. So No. 1, it is a large placebo effect. No. 2, for our whole lives we have been told these drugs work. And No. 3, we all got better from every cold we ever had -- so we are apt to believe the drugs helped. But if people take an inactive placebo, they would get just as well, just as fast.

Are all of these types of drugs dangerous?

Paul:
Any medicine we give to any child has the potential for side effects. The issue here is the risk/benefit relationship. So if we have medicines not proven effective, any side effect is too great.

Are any of these drugs particularly dangerous?

Paul:
Because the antihistamines I mentioned [brompheniramine, chlorpheniramine maleate, and diphenhydramine] are sedating, they can be dangerous to young children already having breathing difficulties. And the decongestant pseudoephedrine could be dangerous to children with heart conditions, whether or not those conditions have yet been diagnosed.

These drugs have been on the market for years. Why take them away now?

Paul:
There has been increasing evidence of lack of effectiveness and of some serious side effects. This raises the question of whether they should remain available for the treatment of cough and cold. There is a place for antihistamines in the treatment of children's allergy and allergic reactions.

Shannon:
This issue could have and should have been addressed a long time ago. The data showing lack of effectiveness have been around for more than five years. The answer to your question, from our perspective, is the number of deaths and adverse events in children continued to mount so much the issue could not continue to be ignored. It was OK not to start a battle over the drugs being ineffective, but it became mandatory to become vocal when it became clear they were unsafe.

If the harmful effects of these drugs are due to overdose, why can't the FDA trust me to read the labels if I opt to give these medicines to my child?

Shannon:
I think this is the most important misconception about this issue. The fact of the matter is these adverse events are not confined to overdose. While the majority of these events and deaths were the results of overdose, a significant percentage were unexpected effects or exaggerated effects in children who had underlying illnesses or who were taking other drugs the cold drugs interacted with. No amount of better labeling, better education, or better poison prevention would prevent that.

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