ROUND 2: The FDA and OTC Cold Medications for Infants
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.
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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%).
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- 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.
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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.
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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.
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* 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
11 Comments:
When I was a child, my mother served me clove tea with lemon. To this day, whenever I smell cloves, I'm filled with memory of her care and her love.
To be honest, Dr. P. in the middle of the night when your child is miserable, it's hard to resist the temptation to give a cold medication, even if we know it;s not the right thing to do.
I just tried honey last week owith my 3 year old. I can say it seemed to work as well (or as poorly) as cough/cold medicine, but at least I didn't have to worry about side effects. Thanks for the suggestion.
My son is 6 and just the other day he was throwing up, coughing, and generally feeling misrable. If he was with his mother (we have joint custody) she would have had him off to the Dr. faster than this page loads. I on the other hand simply had him lay down rubbed his back and made sure he stayed down most of the day drinking clear liquids and light foods. next day i kept him home from school to make sure but he was fine and by day three no symptoms back to his self. I am a firm beleaver that people over medicate their kids and or themselves and not just letting your body handle it. Like any drug by continual taking of drugs ie antibiotics , cold meds, sleep pills, we are only telling our body to weaken itself.
I think we as a people got MRSA because of over taking anitbiotics to much and now the bacteria evolved and became immune. and now its a major problem and no way to stop spreading it.
I will continue to let my sons sickness run its course and le t the body do its job. If he gets worse or to severe ofcourse ill be off the the ER. I know some parents hate ot see their kids suffering but isnt that why we tell them its hurt me more than you when we punish them.
My husband is a "take the pill" Dad, while I'm the "let the cold ride, have some Sleepytime tea" Mom. The liquids taste awful, and it's a big fight to get a kid to take them anyway. So I didn't give my kids cold meds to begin with. But now I have ammunition when Dad wants to dose the little people up. Don't think I won't use it. "It's not good for them, honey."
I just have one question. So none of the adults here not giving any relief to their little ones takes any medication when they are suffering with their colds right?If you follow instructions and supervise your children there should not be an issue. The article said that two thirds of these cases are ages 2-5 and usually had some sort of lack of supervision. So what do the under two's have to due with the restrictions?? Maybe the parents should get into some sort of trouble for leaving the meds accessible. These meds generally have some sort of child proof cap too so if closed correctly how are the kids getting into them. I am not one to constantly medicate but the option shouldn't be taken away because some people can't or won't follow directions.
I believe that the reason people are overmedicating is because the package does not give the correct dose for those under two. It just says "consult a doctor". We all know what consulting a doctor entails: taking off work, bringing your kid in, paying the copay for insurance etc. People today can't afford to take time off and pay all the fees. If the drug companies would just give the correct dosing on the package they would be able to medicate their child properly. I have used pediacare for my kids in the past and it does help but I am also a nurse with access to correct doses so my children never had a problem with it.
I think one of the biggest problems is that people don't understand the chemical names of these medications. Sometimes children are being overdosed simply because their parents don't realize that many OTC meds that claim to have different uses are, in fact, the same medication. Ex: Benadryl (for allergies, itchies and snifflies) is Diphenhydramine and Dimetap Nighttime Cough is actually just Diphenhydramine. So, a parent could give their little the two meds thinking they are different. Chemical names need to be more prominent and more parent education needs to be done.
I was under the impression that acetaminophen or ibuprofen really won't help with a cold but when my 3 year old daughter falls and hurts herself or she has a fever I won't hesitate to give her an OTC medication (without calling a dr.)if I feel that she needs it. It's just odd I think that I even had to research this entire thing. A friend scared me the other day with "OMG Don't give your baby Tylenol, you know that it was recalled?!?!?" Just something else for hypochondriacs to use because there isn't enough information given. If people where more educated about the proper doses and the actual use of OTC then this story wouldn't even exist... Sad...
There seems to be a basic dichotomy here that none of the medical world has effectively answered for me. If these drugs have no measurable effect, then what ingredient causes the negative effects that require them to be recalled? Obviously the drugs must do something for there to be any effect positive or negative. . . and while I am a fan of letting my children learn to tough it out, with falls, emotions, etc. at some point when your little one is up a night trying to fall asleep but with a post nasal drip you can almost hear, isn't there anything that can be done to help other than saying, I love you, you work it out (even if you're only two and have no idea what that means. . . ?)
My son, despite a year of breastfeeding, ended up with his father's allergies. They started showing up when he was 8 months old and we took him to the ER because he was swollen from head to toe. The doctors there told my husband and I to give him Benadryl for the next few days. After one or two doses, he was swollen and misrable. Now he is 14 months and he's suffering from the pollen and other indoor/outdoor allergies. One day he woke up with his eyes swollen shut. So of course I'm going to give him eye drops with antihistamine and some allergy medicine. His pediatrcian ended up giving me a sheet with the correct doses for the medicines because it would help him not suffer. So, I've had more than 3 doctors tell me it was ok for him to use these products, some OTC. I don't like giving him medicine, I don't like taking medicine myself, but I'm not going to watch me son suffer because he can't breathe or see due to allergies.
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