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KristinasMama
How did she turn 2 so quickly?
Member since 10/07 8257 total posts
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Blessed Mama of Kristina Elena
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FDA considers banning OTC cold medicine for kids...
While I understand the premise of all this..... it kind of angers me somewhat.... Knowing how doctors don't want to give prescription meds for colds... What do we do when our children have coughs/congestion if this happens?
RCVD from BabyCenter Baby Bulletin
FDA considers banning OTC cold medicine for kids
Thu, Oct 2, 2008 (HealthDay News) — After recommending earlier this year that children under the age of 2 not receive over-the-counter cold medicines, the U.S. Food and Drug Administration on Thursday is meeting with the public to help answer an even more important question: Should kids' cold medicines remain "OTC" at all?
The issue is not a new one for regulatory bodies or the public.
In January, the FDA issued an updated health advisory recommending that over-the-counter (OTC) cough and cold preparations not be used to treat children under the age of 2 due to the possibility of life-threatening complications. These products include decongestants, expectorants, antihistamines and cough suppressants.
Just prior to the advisory, the makers of dozens of cough and cold remedies marketed for infants voluntarily recalled the products.
Despite scant evidence that such remedies are actually effective in children or adults, an estimated 10 percent of American kids take one or more cough and cold medications during a given week.
Yet the preparations can do more harm than good, research suggests.
An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine. Most of the deaths involved children younger than 2.
And the U.S. Centers for Disease Control and Prevention reported that some 7,000 American children under the age of 11 are treated each year in hospital emergency rooms because of problems with cough and cold medications.
According to Dr. Michael Spigarelli, an assistant professor of pediatrics and internal medicine at Cincinnati Children's Hospital, the recent debate originally stemmed from a lawsuit by a group of pediatricians who felt that cough and cold medicines were unsafe — or at least never proven to be safe. This led to the FDA's statement earlier this year regarding young children.
Spigarelli will be testifying at the hearings. "The current hearings are looking at a wider pediatric age range," he said.
"If the FDA takes those medications off the market, the impact on the public is unknown at this point," said Chanin Wright, a pediatric clinical specialist with Scott & White and an assistant professor of pediatrics at Texas A&M Health Science Center College of Medicine. "There's a risk that the parents would turn to adult formulations for their children which could potentially cause harm. I don't think the FDA wants that so they're asking for expert opinion."
In addition to considering whether these medications should be over-the-counter or prescription, the hearings will cover a wide swath of territory, including questions of dosing and age range.
One of the most provocative issues is that of testing: What types of studies, if any, should be conducted in children and how should these studies be designed and powered?
"Testing in children is intensively debated," said Spigarelli. "It is felt by the FDA and most regulatory authorities that it is unethical to test in children, which means that pediatricians and family medicine doctors are left prescribing off-label, because it's equally unethical to let a kid suffer."
According to Spigarelli, 150 or so drugs have been tested in children since the Best Pharmaceuticals for Children Act, passed in 2002. The act extends the amount of time a pharmaceutical company has exclusive rights to market a drug if that company conducts studies in children of drugs the FDA thinks might be useful in younger age groups, he said.
But the reality remains that few drugs have actually been tested in pediatric populations, Spigarelli said.
"The world [notably, the European Union] has shifted to doing more testing on children, but most of the medications used on children have not been tested, and cough and cold medicines are in that category," he said.
-- Amanda Gardner
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Posted 10/7/08 11:37 PM  |
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Long Island Weddings
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noodles
LIF Infant
Member since 10/07 311 total posts
Name:
Pooh Bear
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Re: FDA considers banning OTC cold medicine for kids...
What concerns me more is that at DD's 4 month checkup we got a prinout from the Dr office that said we could give DD these medicines if she had nasal congestion. The article I read said that these medicines have been linked to infant deaths. WTH!
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| Posted 10/8/08 7:03 AM |
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bella
LIF Adult
Member since 5/05 1871 total posts
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Re: FDA considers banning OTC cold medicine for kids...
unfortunately I'm not surprised by this .....It will be a loss for the companies that make these but that's a whole other topic.....
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| Posted 10/8/08 7:11 AM |
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hbugal
Lesigh
Member since 2/07 15928 total posts
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Re: FDA considers banning OTC cold medicine for kids...
There is NOTHING wrong with any of these OTC medications...nor was there anything wrong with the infant OTC meds either. The issues were with overdosing due to parent error...it's sad but it's the truth.
Somewhere in the report they say that they dont work on children or infants. Well maybe not enough to be "statistically relevant" but take it from me...a parent with several older children...the decongestant definitely dried them up and helped them breathe...which helped them sleep..whigh helped them get better.
It might be surprising to some but there are issues of overdosing with Tylenol and Motrin as well...resulting in death. But how are they going to pull them from the market? My eldest daughter went to preschool with a little boy who wound up needing a liver transplant due to a rare reaction to Tylenol....
You can get a decongestant for your children as well as for an infant, over the age of 6 months, from your ped. Ive had it for Caden.....It might sound horrible and I might get flamed..but I told my ped when he was sick with a cold at 8 months or so...that she could either prescribe him something or I was going to give him the childrens meds. She agreed with me on what I said above and gave me a prescription decongestant for him.
If they do go through with pulling the childrens meds from the shelves just do what I am planning on doing...I'll buy a case of it and hope that I dont run out of it before he's old enough to take something else.
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| Posted 10/8/08 8:14 AM |
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Lillykat
going along for the ride...
Member since 5/05 16253 total posts
Name:
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Re: FDA considers banning OTC cold medicine for kids...
I'm not surprised - they were saying this morning on the today show that they are ineffective on very young children and are more for parents who feel they have to give something rather than they actually make the child feel better.
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| Posted 10/8/08 8:17 AM |
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partyof6
b nice like u want ur kidz 2
Member since 7/06 7752 total posts
Name:
jeannine
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Re: FDA considers banning OTC cold medicine for kids...
this is not a new thing.
I personally gave it 1x years ago and never again.
My dd had a cold-my sil told me to give her some otc med-well I had no idea the kid was also having a asthma attack-didnt even knew she had asthma.
She was just quiet---quiet because she didnt have enough air to tallk-my gut told me take her to the ER>
Her heart rate was sooooooooo high she bypassed everyone as a emergency.
There is no cure for a cold-chicken soup-alot of garlic-natural antibiotic and a humidifier-saline nose spray and a elevated mattress.
They should pull these--they have their reasons.
they showed how many deaths were linked to them,
jmho.
I can deal with staying up a few nights if it means my kid is safe.
In this day and age its all about how much crap we can pump into them.
They came right out...and said---the reason they do not pull them is because some brain surgeon willbe like well...I willjust give the adult one though but just a smaller dose--and overdose the child.
SOo they figure its the lesser or two evils and no lawsuit for them.
its allllllll about covering their *** in some way.
I am also shocked some docs still say its ok-Thw twins I was told no way in hell....
makes youwonder sometimes
Message edited 10/8/2008 8:26:17 AM.
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| Posted 10/8/08 8:25 AM |
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sunflowerjesss
Mommy to 3!
Member since 10/05 20369 total posts
Name:
Jesss, duh.
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Re: FDA considers banning OTC cold medicine for kids...
I heard about this on the news last night.
I interpreted it as, the medicines are safe for children, however, the risk for an overdose in a child under 4 is high.
So if the parent could just be careful like they should be this wouldn't be a problem.
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| Posted 10/8/08 8:26 AM |
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partyof6
b nice like u want ur kidz 2
Member since 7/06 7752 total posts
Name:
jeannine
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Re: FDA considers banning OTC cold medicine for kids...
but...heres the thing...
if you have a underlying heart issue you can have a problem too-not just overdosing, and most young children with breathing issues or heart issues are not diagnosed yet.
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| Posted 10/8/08 8:28 AM |
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Disneygirl
Disney cruise bound!
Member since 5/05 8126 total posts
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D
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Re: FDA considers banning OTC cold medicine for kids...
Maddie is the queen of colds and I've never even considered giving her OTC cold medicine. A little chicken soup, extra fluids, some vicks on her chest, a humidifier to sleep with and some saline drops and she starts to improve. Afterall these OTC medications aren't miracle drugs as there is no cure for the common cold.
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| Posted 10/8/08 8:40 AM |
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LuvMy2Girls
@>---------
Member since 5/05 11165 total posts
Name:
Mommy
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Re: FDA considers banning OTC cold medicine for kids...
These meds were NEVER tested on children for decades! There's no proof these meds actually even work.
I'm for this..a cold is a virus, you can't treat a virus with prescription meds, and I find that for myself cold meds just prolong my cold.
I totally agree, I hope they pull it for all kids under 6 and even better under 10. My doc from the very beginning even before this came out last year told us under no circumstances no cold meds for kids under 6.
How do you alleviate cold symptoms in your kids?
The old fashioned way-cool mist humidifier, warm baths with eucalytus, natural vicks vapor rub, an elevated mattress and lots of fluids and rest.
I give my girls Benadryl for congestion when it gets really bad and tylenol or motrin for pain.
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| Posted 10/8/08 8:57 AM |
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LIMOMx2
...
Member since 5/05 24989 total posts
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Re: FDA considers banning OTC cold medicine for kids...
I better go stock up before they pull them again
They said this morning that they don't work and more or less it is in the parents head that it is working. She said use steam and rub the childs back. 
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| Posted 10/8/08 9:58 AM |
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KristinasMama
How did she turn 2 so quickly?
Member since 10/07 8257 total posts
Name:
Blessed Mama of Kristina Elena
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Re: FDA considers banning OTC cold medicine for kids...
I honestly think that the reason why they are doing this is b/c parents are taking these meds and using them as save-alls and not allowing the child's immune system to fight it off like a normal cold should be. I also think that you have people who are allowing them to be taken wayyyyyyyyyyy too much, and thereby increasing the risk for an OD.
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| Posted 10/8/08 10:01 AM |
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cjik
Welcome 2010!
Member since 2/06 8879 total posts
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Re: FDA considers banning OTC cold medicine for kids...
There was a study released last Fall/Winter that showed OTC cold meds for children actually don't work at all, and some of the ingredients can cause problems for the children (besides overdosing issues).
DS just had a bad cold. We suctioned his nose a lot, gave him saline nose drops, lots of liquids, and used the humidifier, and that's about it. He got over it. I don't usually use these meds when I have a cold, so I guess I'm used to not having them.
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| Posted 10/8/08 11:33 AM |
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CrankyPants
I'm cranky
Member since 7/06 18178 total posts
Name:
Mama Cranky
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Re: FDA considers banning OTC cold medicine for kids...
Posted by KristinasMama
While I understand the premise of all this..... it kind of angers me somewhat.... Knowing how doctors don't want to give prescription meds for colds... What do we do when our children have coughs/congestion if this happens?
See, that right there should tell you something. If a Doc doesn't want to give your child anything for a cold, it's because nothing except time will heal it. If there was something to give, the DR. would tell you what it was. I think the reason most of these OTC meds are getting pulled is because they are not effective (they just make the parent feel like they are doing something, because no one wants to see their kid suffer through this). Time, humidifier, baby vicks-that's all you can do.
Of course, there is the overdosing thing as well-though I don't agree with pulling effective medicine because parents don't take the time to read the instructions.
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| Posted 10/8/08 12:01 PM |
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