WASHINGTON, Sept. 28, 2007
FDA: Cold And Cough Meds Could Hurt Kids
No Decongestants For Children Under 2; No Antihistamines For Those Under 6
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Play CBS Video Video Unsafe Children's Medicine? The FDA has concluded that over-the-counter cough and cold formulas are not effective in children and may not be safe. From 1969 to 2006, 123 children died in related deaths. Wyatt Andrews reports.
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(AP / CBS)
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Quiz Common Cold Quiz To avoid getting sick this winter, know the basics about preventing colds. Test your knowledge.
The preliminary recommendation, from Food and Drug Administration safety officials, would apply to decongestant use in children under 2 years old and antihistamines in those younger than 6, according to agency documents released Friday.
The more than 350 pages of documents are part of a broad and continuing FDA examination of whether the roughly 800 medicines, many popular and widely used, are safe and effective in treating children's colds and coughs.
"Antihistamine-decongestant combination products," the FDA reports, "are no more effective for symptoms of....infection than placebo in young children." Overdoses were sometimes fatal, reports CBS News correspondent Wyatt Andrews. Between 1969 and 2006, 69 children died after taking antihistamines, and 54 died after taking decongestants.
FDA advisers are to take up the issue during an Oct. 18-19 meeting. The FDA has not decided on any label changes. Action probably is pending a recommendation from outside experts.
The review came in response to a recently filed petition by city officials from Baltimore, Maryland, who charged that many over-the-counter cough and cold remedies can harm toddlers and preschoolers. Those officials, joined by the American Academy of Pediatrics, cited evidence that suggests the drugs not only are risky but also do not work in the very young.
"The basic question is, why should a product be so relentlessly marketed when it's not safe or effective?" said Dr. Joshua Sharfstein, Baltimore's health commissioner. "It does not make sense, in the absence of information, to say 'consult a physician,' because they do not have superhuman powers. They cannot make a product safe or effective."
The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines, said it recommends strengthening the labels on the medicines to help reduce misuse and confusion about their use in children, particularly in those younger than 2.
Among the deaths, most occurred in children younger than 2.
The Baltimore petition came in the aftermath of a Centers for Disease Control and Prevention report that found more than 1,500 toddlers and babies wound up in emergency rooms of U.S. hospitals over a two-year period because of the drugs.
© MMVII, CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.
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- Is this the same FDA that allows massive amounts of mercury in our vaccines? Why don''t they stop that? Because it makes more money for the medical field! This is about BUCKS and NOT SENSE!
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- Is this the same FDA that allows LARGE doses of mercury in our vaccines? I for one am not going to listen to this. There has to be a buck behind this somewhere! FDA is about DOLLARS and NOT SENSE!
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And I so agree with you. But it''s not just "young" parents these days (In fact, the average age of women having babies is now in their 30s, FYI) it''s society as a whole. We''re so obsessed with everything being done fast --- look at fast food, to get them even faster, we have drive through, becuase God forbid we get out of our cars. Forget about making dinner.Everyone is in such a hurry. It just gets to me when children are being todl to swallow bottle of cough medicine, when hot lemon juice and rest with a balanced diet is what they really need.- Reply to this comment
- Why doesn''''t the article or the FDA say whether the deaths were caused by overdosing? There''''s a BIG difference between taking a medicine and taking too much of it.
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Posted by incog-nito at 12:37 PM : Sep 29, 2007
You are correct. Many parents themselves pop pills for any little affliction...so they don''t try home remedies first. And many young parents might think if the first dose didn''t work...just give more medicine.
Children in this age group are prone to ear infections and many doctors do recommend to start them on antihistamines and decongestants at the start of a cold to prevent a raging ear infection which might end up needing antibiotics. - Reply to this comment
- KGERRELS said, "PEOPLE- George W. didn''''t "invent" the FDA... Makes about as much sense as Al Gore inventing the internet or global warming !!"
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Today, Al Gore is credited by internet principals with the first legislation to establish the internet, and this is what Gore took credit for. Gore never claimed to have invented the internet, but this claim was falsely attributed to him by an RNC public relations staffer. Likewise, Gore did not take credit for, nor invent global warming, however much Buxh would like to believe it.
Bush, however, did allow the FDA to become a haven for political cronies and a model for asrounding incompetence and narrow special interest politics-- usually for Big Pharma. This was not the first time. In the same fashion, Bush allowed FEMA to become a mockery of its former self, so when Katrina hit, FMEA had lost all credibility. - Reply to this comment
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- Babies should not be taking strong medicine at all. When I was small medicine like this was never given to babies because they knew it was dangerous. What happen to good old honey and lemon the old fashioned way. If we were had a problem with the breathing Mom would boil water and use the steam and it would clear up our lungs and we would breathe better. Those are old fashioned but it worked. Or just old fashioned vicks with warm towels on the chest or rub vicks behind the ears that works as well and it does not harm the child at all.
I guess parents are not willing to work hard at helping their child when they have the simple things to help them.
This strong medicine does not have to used for everything and that is a fact.
I guess these young parents today never ask their Moms how to help their grand children? - Reply to this comment
- Why doesn''t the article or the FDA say whether the deaths were caused by overdosing? There''s a BIG difference between taking a medicine and taking too much of it.
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- Okay, if I bought a new style cold remedy and added booze to it, would that make the new remedy as effective as the old school remedy, which was 21% alcohol to start out with?
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- My pediatrican told us about the dangers of over the counter cough medicines back in the 1980s. Unless, one has diagnosed sinus conditions, the best way for children to deal with colds is with some hot drinks use as warm water, with lemon juice with a little sugar, plenty of other fluids, and yes rest.
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- Outside Experts...Who? the manufacturers !! Do Me A Favour, who allowed it out in the market place before these so called "Outside Experts" checked it out. Simply another load of Big Pharma money making junk. FDA, rotten to the core.
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- The FDA is about MONEY - not SAFETY...
Welcome to Bush''s Amerika... - Reply to this comment
