Cold remedies for small children

In a nutshell — none of the preparations sold over-the-counter to treat upper respiratory infections in children work, and all could be dangerous. That’s the conclusion of a recent report by the Food and Drug Administration. You can read about the details of the decision, as well as the history of how and why these cold remedies were regulated in the past, here.

There is a huge market for these products. Ninety-five million packages of them are sold each year, and drug companies spent over 50 million dollars last year marketing them in various ways. The implication of the advertising is that these preparations (most are mixtures of several things) are safe.

In fact, they are not. Poison control centers have received 750,000 calls about them since 2000, and The Centers for Disease Control found that over 1500 children under two were seen in emergency departments owing to their side-effects. The FDA even found 123 deaths linked to their use. Possible side-effects can include hallucinations, dangerous over-sedation, and serious heart rhythm disturbances. Over the years I myself have cared for several children in the PICU who had serious side-effects from them.

The problem isn’t just over-dosing errors. The problem is we don’t know the correct dose for children, and estimating how much to give from adult doses is misleading and dangerous. The fundamental problem, though, is that they just don’t work. In fact, a total of six carefully randomized studies testing these agents in children under twelve all showed they worked no better than placebo — in other words, a sugar pill worked just as well. So using them puts a child at some risk with no benefit.

If you have questions about cold preparations, by all means talk to your child’s doctor about it. But the growing consensus among physicians is simple — don’t use them in small children.