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Don't Give Your Child Cold Medicine
Update: This information has been updated by new FDA guidelines. Please see our WebMD article here.
Last week the Food and Drug Administration (FDA) issued a warning to parents: don't give infants and toddlers over-the-counter (OTC) medications for colds. Why not? Because those medications, many of which have been pulled off the shelves by their manufacturers over the past few months, may do more harm than good, overall.
Of course, it's a little more complicated than that.
First of all, we're talking about medications that have been marketed for infants and toddlers - 0 to 2 years of age.
Consider the possibility that an infant or toddler could be given more than the dose prescribed on the label. This might happen when they are given more than one medication (to treat more than one symptom, say a cough and sneezing), each of which contains the same active ingredient. It could also happen when they are unwittingly given multiple doses by multiple caregivers (say a day care staff member, dad, and grandma). Either way, the result is unintentional overdose.
While such overdoses and other adverse reactions may be the exception, they are not rare. Add to that the fact that many of these medications have not been demonstrated to be effective in infants and toddlers, and there is just no reason to expose these children to the risks for no proven benefit.
Let's take a step back and ask a couple of questions.
If the medications in question have not been shown to be effective in children, then why are they being marketed for children in the first place? It's not that they have been proven ineffective. Rather, it's that they have not actually been tested in clinical trials in children. Many have only been tested in adults - that's how they received FDA approval. In those tests, they were shown to be safe and effective at relieving symptoms - in adults. It was just assumed, then, that they would be safe and effective in children - in lower doses. But, in fact, they have never been shown to relieve symptoms in children.
How is it the medications were never tested in children? Probably because of the risk and expense of testing them in children. What if something goes wrong? As I described in a blog posted here two years ago this month, it is not uncommon for a new drug to be tested in adults, but not children (or pregnant women), for fear of harming the research participants.
As a result, we are now at a point where we'll need to await the results of clinical trials of cold medications in infants and toddlers before these products can reappear on the pharmacy shelves. That is, if the manufacturers believe the cost of conducting the clinical trials is worth the potential market.
Something to remember - cold medications do not "cure" a cold, anyway. They only treat the symptoms of a cold, making the person, child or adult, temporarily feel better.
-Joe
Related Topics: Technorati Tags: infants colds, medications, clinical trials
Last week the Food and Drug Administration (FDA) issued a warning to parents: don't give infants and toddlers over-the-counter (OTC) medications for colds. Why not? Because those medications, many of which have been pulled off the shelves by their manufacturers over the past few months, may do more harm than good, overall.
Of course, it's a little more complicated than that.
First of all, we're talking about medications that have been marketed for infants and toddlers - 0 to 2 years of age.
Consider the possibility that an infant or toddler could be given more than the dose prescribed on the label. This might happen when they are given more than one medication (to treat more than one symptom, say a cough and sneezing), each of which contains the same active ingredient. It could also happen when they are unwittingly given multiple doses by multiple caregivers (say a day care staff member, dad, and grandma). Either way, the result is unintentional overdose.
While such overdoses and other adverse reactions may be the exception, they are not rare. Add to that the fact that many of these medications have not been demonstrated to be effective in infants and toddlers, and there is just no reason to expose these children to the risks for no proven benefit.
Let's take a step back and ask a couple of questions.
If the medications in question have not been shown to be effective in children, then why are they being marketed for children in the first place? It's not that they have been proven ineffective. Rather, it's that they have not actually been tested in clinical trials in children. Many have only been tested in adults - that's how they received FDA approval. In those tests, they were shown to be safe and effective at relieving symptoms - in adults. It was just assumed, then, that they would be safe and effective in children - in lower doses. But, in fact, they have never been shown to relieve symptoms in children.
How is it the medications were never tested in children? Probably because of the risk and expense of testing them in children. What if something goes wrong? As I described in a blog posted here two years ago this month, it is not uncommon for a new drug to be tested in adults, but not children (or pregnant women), for fear of harming the research participants.
As a result, we are now at a point where we'll need to await the results of clinical trials of cold medications in infants and toddlers before these products can reappear on the pharmacy shelves. That is, if the manufacturers believe the cost of conducting the clinical trials is worth the potential market.
Something to remember - cold medications do not "cure" a cold, anyway. They only treat the symptoms of a cold, making the person, child or adult, temporarily feel better.
-Joe
Related Topics: Technorati Tags: infants colds, medications, clinical trials
