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ROUND 2: The FDA and OTC Cold Medications for Infants
Update: This information has been modified by new FDA guidelines. Please see our WebMD article here.
The FDA has again reiterated their warning that over-the-counter (OTC) cold preparations NOT be given to children under 2 years of age.
I agree with these guidelines, not because I think these meds are especially dangerous when given at the proper dose, but because I've never found them to do much good (except for the parent's need to do something for their snuffling child). And if a medication is ineffective, it isn't worth any risk, however small, especially with infants for whom side effects can be unpredictable and more severe than in older kids.
But that's just me. What do you, the parents, think? You beg to differ.
In a recent study*, 1522 parents with children under age 6 years were asked their opinion of OTC cold medications. Here's what they said:
How might we resolve our friendly disagreement?
That would take a scientific study - such as a "randomized controlled trial" in which some babies with colds got the medications while others got a "placebo" (like sugar water made to look and smell like the meds), followed by the parents rating their effectiveness.
But, alas, that hasn't happened and isn't likely to happen any time soon (certainly not with the under 2 years group). So we are left to guess and to wonder and to try to do the right thing without any scientific evidence. For now, I'm siding with the FDA and choosing to come down on the side of being extra cautious with little ones.
Perhaps this will sound cold to some of you, but I think parents need to learn to tolerate their kids experiencing some unavoidable discomfort. Your fond desire to banish all stresses from the lives of your kids is understandable and universal and...fruitless.
And it can even lead to trouble if the measures used to soothe might carry significant side effects. As we say in the trade, "First, do no harm." Anyway, learning to cope with and triumph over adversity isn't a bad lesson, even for young children.
Finally, remember that TLC is the greatest balm for discomfort. Most of us harbor cherished memories of when we felt lousy as kids and our parents (and others) soothed us with love and tenderness and back rubs and kind words and a loving touch and honey and lemon and... (fill in your fondest memories). TLC is surely the greatest placebo known to child and man, and that's a good thing: it has no known side effects, doesn't cost a penny, and has plenty of medical and emotional benefits.
Related Topics: Technorati Tags: infant cold medicine, infant cough medicine, pediatrics
The FDA has again reiterated their warning that over-the-counter (OTC) cold preparations NOT be given to children under 2 years of age.
I agree with these guidelines, not because I think these meds are especially dangerous when given at the proper dose, but because I've never found them to do much good (except for the parent's need to do something for their snuffling child). And if a medication is ineffective, it isn't worth any risk, however small, especially with infants for whom side effects can be unpredictable and more severe than in older kids.
* * *
But that's just me. What do you, the parents, think? You beg to differ.
In a recent study*, 1522 parents with children under age 6 years were asked their opinion of OTC cold medications. Here's what they said:
- Only 1/3 of parents stopped using OTC cold medications following the FDA warnings in October, 2007.
- Most parents believe children's OTC cough medications to be at least somewhat effective in relieving cold symptoms and promoting sleep. ("Very effective" = 14-18%; "Somewhat effective" = 47-60%; "Not too effective" = 10-16%; "Not at all effective" = 4-14%).
* * *
- You are right and I am wrong (hey, it happens). Especially since there is some evidence these may help a little in adults, it's possible they also provide some relief to infants and toddlers. Additionally, I'm so skeptical, I don't believe parents when they tell me the medications helped, so I'm hardly an objective judge.
- I am right and you are wrong. It's simply wishful thinking (a "placebo effect") on your part. "Believing is seeing" and parents, desperate to provide comfort, judge any little improvement in the cold symptoms (which, after all, are going to get better on their own) to be due to the meds.
- We are both right. Occasionally these meds provide a little relief, although not consistently, and not to any great degree.
* * *
How might we resolve our friendly disagreement?
That would take a scientific study - such as a "randomized controlled trial" in which some babies with colds got the medications while others got a "placebo" (like sugar water made to look and smell like the meds), followed by the parents rating their effectiveness.
But, alas, that hasn't happened and isn't likely to happen any time soon (certainly not with the under 2 years group). So we are left to guess and to wonder and to try to do the right thing without any scientific evidence. For now, I'm siding with the FDA and choosing to come down on the side of being extra cautious with little ones.
* * *
Final ThoughtsPerhaps this will sound cold to some of you, but I think parents need to learn to tolerate their kids experiencing some unavoidable discomfort. Your fond desire to banish all stresses from the lives of your kids is understandable and universal and...fruitless.
And it can even lead to trouble if the measures used to soothe might carry significant side effects. As we say in the trade, "First, do no harm." Anyway, learning to cope with and triumph over adversity isn't a bad lesson, even for young children.
Finally, remember that TLC is the greatest balm for discomfort. Most of us harbor cherished memories of when we felt lousy as kids and our parents (and others) soothed us with love and tenderness and back rubs and kind words and a loving touch and honey and lemon and... (fill in your fondest memories). TLC is surely the greatest placebo known to child and man, and that's a good thing: it has no known side effects, doesn't cost a penny, and has plenty of medical and emotional benefits.
* * *
* NPR/Kaiser Family Foundation/Harvard School of Public Health
Children's OTC Cold Medicines: The Public, and Parents, Weigh In
For the FDA advisory on this:
http://www.fda.gov/CDER/drug/advisory/cough_cold.htm
Children's OTC Cold Medicines: The Public, and Parents, Weigh In
For the FDA advisory on this:
http://www.fda.gov/CDER/drug/advisory/cough_cold.htm
Related Topics: Technorati Tags: infant cold medicine, infant cough medicine, pediatrics
