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Cold and Cough Label changes - "Do not use" under 4 years old



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Oct 09, 2008 05:37 PM

Cold and Cough Label changes - "Do not use" under 4 years old

by brian Staff

FDA MedWatch- OTC Cough and Cold Medicines- Product Labels Being Modified To State " Do Not Use" In Children Under 4 Years Of Age

FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.

Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Press Release regarding the above issue at:
http://www.fda.gov/medwatch/safety/2....htm#CoughCold


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13 Comments
No. 1
from HonestRN
Old Oct 09, 2008, 06:16 PM

Default Re: Cold and Cough Label changes - "Do not use" under 4 years old
it must have been unofficial when they announced that last year. Personally I don't think any children under 6 need OTC cough and cold meds.
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No. 2
Old Oct 10, 2008, 06:50 AM

Default Re: Cold and Cough Label changes - "Do not use" under 4 years old
I gave it to my children when they were as young as two - dosage by weight. When they're sick and coughing so much they can't sleep and they're crying, they need something. And yes, tried soothing drinks and humidifier first. Did not work, cough suppressant did.
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No. 3
from RNmom08
Old Oct 10, 2008, 10:52 PM

Default Re: Cold and Cough Label changes - "Do not use" under 4 years old
HonestRN:
That's just silly. That's like one of the docs who said once, "They don't need anything for pain, kids don't feel pain." (this was said of a child who had broken his femur in 2 places.)

Why would you say that a child wouldn't need relief from a bad cold? I have seen my children utterly miserable with head colds. Have I given them something for their symptoms? You bet. Have I taken medications for my symptoms when I feel horrible? DEFINITELY!

IF my child is up coughing all night and there is something I can give them to relieve that... I don't have a problem with that.

Are you implying that instead of OTC meds the child be taken to the doctor every time? or just suffer?

Don't get me wrong - I'm not going to just start doping my kids up on OTC meds, of course I try other measures first. But if nothing else works for them, well - you get my drift...
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No. 4
from HonestRN
Old Oct 11, 2008, 06:44 AM
Updated Oct 11, 2008 at 06:56 AM by HonestRN

Default Re: Cold and Cough Label changes - "Do not use" under 4 years old
RNMom08,

I have 3 children now ages 13, 15 and 23. I found plenty of natural remedies to relieve cold symptoms. The APA came out with a similar statement last year concerning OTC cough and cold meds for kids because a number of studies found them basically ineffective. Helps the parents more than the kids. Pain and cold symptoms are so NOT apples and apples. What do you think parents did before all these OTC meds for colds came out?! I ask you RNMom08, why would you give your child meds that have not been proven safe or effective?

"Committee member Sean P. Hennessey, PhD, of the University of Pennsylvania School of Medicine, said the over-the-counter cold medicines should not be used in children "given that there’s no evidence of efficacy of the drugs and there’s evidence of harm of the drugs." from:http://www.webmd.com/cold-and-flu/ne...ine-young-kids

"Several studies show that these medicines are ineffective in children. They can potentially cause side effects that could lead to more serious symptoms." From http://abcnews.go.com/GMA/OnCall/story?id=2612975
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No. 5
Old Oct 11, 2008, 10:23 AM

Default Re: Cold and Cough Label changes - "Do not use" under 4 years old
Not to start a fight here but HONEST RN do you know that all of your "natural remedies" are both safe and effective per the FDA?? Because if I am correct I think the FDA does not regulate some of our "natural remedies". I think it is unfair for all of our children to be punished with the symptoms of the coughing and sneezing and nasal drainage of an illness because "SOME" of the population was overmedicating their children and didn't understand the correct dosing and usage of most of the OTC medications and not allowing it to be bought for children under 4 is the only complete regulation they can do.

Honest RN for you to insinuate that RNmom08 would be less of a mom than you for using OTC if it worked, after trying other natural forms of treatment first, is unfair. I can honestly say that when your child is up all night long with coughing fits so strong they are vomiting, or congestion so severe they are gasping for air in their sleep, you are willing to try anything when your first few steps don't work. Because we all know that if a person is not allowed to sleep they will not heal, they just become more rundown...that is basic nursing.

I do not overmedicate my child, I do not overmedicate my patients but if they are given medications to aid in their recovery and it works I am all for it. I absolutely believe in natural remedies but I also think that it takes a combination of both eastern and western medicine to do so. What works for one person may not work for another...we are all different and I KNOW there are some OTC medications that are the only relief for my DS when he is ill...I also don't want to throw hime on antibiotics everytime he gets the sniffles which is what would most likely happen if I took him to the DR everytime.

Your articles posted were interesting but I need a bit more information such as symptoms to look for and adverse reactions from the medications if given...instead its like being told we can't give it to our kids "just because..." and "Because I said so..." I also try to make completely informed decisions and if that requires questioning authority then I will do so...
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No. 6
from HonestRN
Old Oct 11, 2008, 11:09 AM

Default Re: Cold and Cough Label changes - "Do not use" under 4 years old
Originally Posted by midmichiganRN View Post
Not to start a fight here but HONEST RN do you know that all of your "natural remedies" are both safe and effective per the FDA??
I know they are absolutely safe....lots of fluid; h20 and decaf herbal tea, saline nasal drops, bulb suctioning, sucking on hard candy to soothe the throat and cough, sitting in a bathroom with a hot shower running to loosen congestion. All natural and all worked very effectively for each of my children. Sure, it takes time and patience when I can sedate my child with some OTC med but I would rather not. I rarely take my kids to the Dr and avoid antibiotics unless absolutely necessary. My kids are wonderfully healthy and not OTC med junkies for every sneeze and sniffle they get.

I did not insinuate RNMom08 is any less of a mother. Just wondering why anybody would use medications on their children that the FDA and APA recommend against. I am also aware that the proliferation of OTC cold remedies for babies and children is relatively recent and that parents made do for many years without them and somehow their children survived the common cold.

I think it worth your time to research this issue further as I have.
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No. 7
Old Oct 11, 2008, 11:14 AM

Default Re: Cold and Cough Label changes - "Do not use" under 4 years old
First... yes herbal whatever remedies aren't deemed safe by the FDA... however doesn't mean they are safe.. or are dangerous. Many have been used forever with great effect, others not so much lol.

A drug being approved by the FDA doesn't mean its safe either. Look at the reports about Giadasil. Many parents believe tylenol and motrin are safe for their children yet know not one of the potential side effects or "risks" of taking it. So there is no right or wrong... we all as parents do what we feel is best. Some believe natural remedies are better and safer than ones deemed ok by the FDA. Others think natural stuff is like poison... we all will never 100% agree.

I think its incredibly stupid my child cannot have cold or cough meds because some parents were stupid and chose to OD their kids. That said I try to avoid cold and cough meds because even in adults their effectiveness isn't always 100% and the side effects can be worse. I have survived my colds and coughs without cough meds so to say anyone isn't caring for their child by not giving them is really out of tough with reality..lol most of us aren't going to die from a cold lol altho we may feel like it.

and totally OT... midmichiganRN.. where ya from :P I think I may be near you
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No. 8
Old Oct 11, 2008, 11:48 AM

Default Re: Cold and Cough Label changes - "Do not use" under 4 years old
MIcrunchyRN...I'm from Ithaca?? YOU?? How funny!! I actually consider myself crunchy!!

Honest RN... I have read up on information, very often treat my child with homeopathy for everyday illness and as a last resort use OTC medication to treat him. I am very patient and diligent with treating MY child and I don't just SEDATE him...(though i'm sure I'm not the only one to whom this thought has passed...LOL...) I have a child who is truly ILL sometimes. He has a weaker immune system and a cold that may pass in a few days for most kids lasts WEEKS for him. A cough that most kids are able to sleep through and is more annoying than anything else, my child wakes up vomiting because he is coughing so hard neb tx didn't work and I tried the warm shower, and the brisk cold air and the menthol and eucalyptus...I push fluids, I give chicken noodle soup...I try everything before I give meds but sometimes the medications are the only thing that works.

And regarding sedation...That is NOT what I meant when I was talking about rest...I meant helping to aleviate some of the symptoms that are causing the child to not sleep allows them to GET some sleep...not to SEDATE him with medicine so I can sleep.
And for doing my research...I HAVE I have also spoke with many pharmacists and read research online...and usually get the same answer. The true problem was that parents were not reading the directions...think more is better and over medicated their child...placing them in the hospital or worse. When looking at it from that perspective all medications if not given properly have the potential to be very harmful, cause much worse side effects than it helps and should be outlawed. Proper teaching should come with all the medications before parents can buy them...perhaps make it so they can only be purchased through the pharmacy...make them sign a form saying they were taught and understood proper usage of medicine. I just don't think people realize that although they can get it without a Dr's prescription it can still be harmful. Medicine is medicine...OTC or not.
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No. 9
from justme1972
Old Oct 11, 2008, 12:55 PM

Default Re: Cold and Cough Label changes - "Do not use" under 4 years old
I think the keyword here is "misuse". Some parents medicate their children like they medicate themselves..they don't read directions and for some reason they don't think you can overdose on OTC's.

I do disagree with the research that these products don't work. I use the Triminic Cold and Cough strips with my children for the past 2 years, and they work better than the more potent, prescription cough supressants.

I also discovered...they work on me! I have never been able to take liquid medication...I'll throw it right back up...every time I get a cough, I have to take codeine which meant mommy was "laid out" on the couch for the rest of the day.

Now, I use the kid's strips, and don't have to worry about that anymore...don't know what's in them, but they work.

However, there were probably products that didn't work...Tylenol cold and cough, never put a dent in anything they have ever had.
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