Michael Shannon, MD, MPH, a pediatric emergency medicine physician and pharmacologist/ toxicologist at Children's Hospital Boston, recently testified in front of the Federal Drug Administration (FDA) on the dangers of giving cough and cold medicines to children under age 6. In this interview Dr. Shannon discusses these dangers and offers advice to parents on how to safely treat their child with a cold.
What decision did the FDA make regarding the use of cough and cold preparations in young children?
A Federal Drug Administration (FDA) Advisory Committee recently made a very important decision. They voted that there are no data supporting the use of cough and cold preparations in children under two and there are no data supporting the use of cough and cold preparations in children between the ages of two to six. They were unanimous in their opinion that these products should simply never be given to children under the ages of two years old.
The term "cold medicines" is confusing actually because these products can have more than one ingredient, but as a general rule when we talk about cough and cold preparations were talking about agents that reduce congestion, suppress cough, maybe help bring up secretions, or that treat fever and aches.
Why are cough and cold preparations not suitable for young children?
The problem with cough and cold preparations is two-fold. One, they don't work. We really have abundant scientific data now showing that these products do not reduce congestion and do not reduce cough in children that have colds. Number two, they pose risks, particularly in children under two, but even in older children we have so much data now of serious side effects occurring when parents give these products to young children.
The types of adverse events that were associated with cough and cold preparations went into three general categories. The most common was simple overdose, where a parent or caretaker may have misunderstood the label and given more medication that prescribed. And there was a belief, many thought that that being the case, if parents were better educated and if the labeling was better, that those problems would go away. But there are other types of adverse events from these medications. First, the medication can be given in the right dose to a child taking another medication and a drug interaction can occur which can lead to serious adverse events. And then also, your child may have an underlying illness; may have recently had cardiac surgery of some type. That type of child, even if given a cough and cold preparation in the right dose could have an adverse untoward event. So, overdose, drug interaction, adverse event in a child with an underlying condition, those are the three general categories of problems associated with these agents.
Can these medications be used to help children fall asleep?
I think another important lesson from what's happened in terms of withdrawing the recommendation to give cough and cold preparations to young children, is realizing that many parents routinely give these medications to children just to put them to sleep. Many cough and cold preparations contain antihistamine such as Benadryl which can make a child sleepy, but it's such a bad idea to give a young child a cough or cold preparation simply to put them asleep. As a general rule, sedatives are not good for young children and have a risk of side effects.
Should parents worry if they've already given their child cough and cold preparations?
There's no reason to be alarmed if you've been giving your child a cough and cold preparation, there's no long-lasting harm from them. Really the point is, now looking forward, we really should not be giving these to young children, and they really have the potential to hurt young children.
If a child has a cough or cough, are there any safe medications that can be used?
There just aren't any medications that have proven to be safe and effective in young children with a cold. The cough suppressants do not work to suppress cough; the decongestants do not work to reduce congestion. The good news is that a cold will last three to four days and then their child will be fine.
If your child has a fever or feels achy, we do recommend use of Tylenol or Motrin, acetaminophen or ibuprofen. Those are medications that we know to be safe and effective in children, so if your child is uncomfortable with a fever, you certainly can make them comfortable. But there really is nothing that a parent can do that's going to significantly reduce the cough or congestion.