No Cold Meds For Kids Under 4

Industry Makes Voluntary Recommendations About OTC Use For Youngsters After FDA Cites Lack Of Safety Data

(CBS/AP)  Children under 4 should not be given cough and cold medicines, companies that make those products said Tuesday in announcing new guidelines for their use.

The industry has been criticized by pediatricians for marketing over-the-counter cough and cold remedies for children under 6 despite a lack of evidence that they work, and reports of safety problems.

Linda Suydam, president of the Consumer Healthcare Products Association, said the companies were voluntarily making the change "out of an abundance of caution." The association represents leading manufacturers and distributors of nonprescription, over-the-counter medicines and nutritional supplements.

The companies will also add a warning to their product labels saying parents should not give young children antihistamines to make them sleepy. Antihistamines are used to relieve allergies.

Government health officials said last week the issue needed additional study.

Last week, FDA officials said at a public hearing they were uncomfortable with the lack of solid scientific data to support continued use of over-the-counter remedies with youngsters, particularly from ages 2-6.

Critics says the effectiveness of such medicines in children has never been proven, and problems with the drugs sent around 7,000 kids to the emergency room last year, reports CBS News correspondent Nancy Cordes.

"When a treatment is ineffective, its risks - unless zero - always exceed its benefits," Dr. Michael Shannon of Children's Hospital in Boston told the FDA panel.

"We don't see a public health emergency here as far as an inherent risk of the products," said the FDA's Jenkins.

But he agreed with critics who say there's no proof the medicines work in kids. "We don't see that adequate evidence of efficacy has been demonstrated in children to date," said Jenkins.

The FDA said Tuesday that it supported the manufacturers' action.

In a conference call with reporters, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, and other officials said that the label change "in no way supersedes" the FDA's ongoing evaluation of the safety and efficacy of OTC cough and cold medicines for children.

Asked if the FDA had requested that CPHA make the label changes, Woodcock said, "We certainly had discussions with them about changing the labels because we recognized that the rulemaking process will take several years at best."

Medicines with the new labels are starting to arrive on store shelves now (which is why the CPHA made the announcement). Woodcock said it usually "takes up to half a year" from the time a decision to change labels is made for medicines with new labels to begin showing up on shelves, so the decision by CHPA was made months ago and not in reaction to last week's hearing.

She said, "The timing was coincidental."

FDA will not require the removal of medicines with the old labels from store shelves (something not typically required during voluntary label changes). Accordingly, there will be a period where medicines with old labels are on shelves along with medicines with new labels. If parents have questions, the FDA said, they should contact their doctors or pharmacists.

The FDA had warned in January against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers - and officials are not giving a timetable for a decision.

U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.

But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.

[erasmus81]

And who is "they"? Usually, it is a TV spokesman. I remember the first spokesman for Nutrasweet was Chris Everett.

Posted by spiritwalk at 05:54 PM : Oct 07, 2008

Actually, I listen to my doctor. I don''t listen to what I hear on T.V. My doctors office has a nutritionist.

"This is what bothers me. The public''''s knowledge of what they are ingesting is all based on "they say" and not any real scientific evidence."

When I say "they say", I am talking about scientific evidence. It is a known fact that artificial sweeteners are bad. Also a known fact is that the only really good oil is olive oil. Margarines are toxic.
I live in Canada and from what I''ve been hearing on here, about the U.S., I would be careful too about what I''m being told.

Ever heard of Dr. Andrew Weil?
He has written a number of books and tells a lot about what is good and what isn''t.

In the U.S., when you are buying medications, for instance, you have no idea what you are really getting. Here everything is regulated. You know that whatever it says you are getting, is exactly what you are getting.

[spiritwalk]

that they think that it can cause "Reye''''s Syndrome
they figure it could be a combination of having had the flu and also taking aspirin.
They say if you are having a heart attack, you should take an aspirin
Posted by erasmus81 at 01:11 AM : Oct 08, 2008
..................................
This is what bothers me. The public''s knowledge of what they are ingesting is all based on "they say" and not any real scientific evidence.

And who is "they"? Usually, it is a TV spokesman. I remember the first spokesman for Nutrasweet was Chris Everett. A great tennis player, but not someone I would go yo to get information about the chemicals I might be putting in my system.
The basis of the commercial was her walking off the tennis court and telling her "friend" about how great Nutrasweet was. Her friend asked her what Nutrasweet was made from and Chris'' answer was, "Well, it''s not sugar!". That was the point where everyone''s alarm bells should have been going off.
But, they didn''t, because people just accepted this without question.
It''s like canola oil. If you ask most people they will say they use it because it is a healthy natural oil that comes from the canola plant. Canola stands for "Canadian Oil Company". Canola oil is a synthetic oil, developed in a Canadian laboratory. But, "THEY" don''t tell you that and "WE" don''t bother to ask.

[erasmus81]

Posted by spiritwalk at 05:54 PM : Oct 07, 2008

Tylenol is basically the same thing as aspirin. It is a pain and fever reducer. I think that the only difference is maybe one ingredient, I''m not sure. But the problem with aspirin is that they think that it can cause "Reye''s Syndrome" in children under a certain age. It''s rare, but if I remember correctly, they figure it could be a combination of having had the flu and also taking aspirin. I''m not totally sure.

"They changed the name to "Low-Dose" and told everyone they would die of a heart attack if they didn''''t take it daily?"

Aspirin, unlike Tylenol, thins the blood. So if you have heart disease, or have a family history of heart disease, it can help prevent blood clots. They say if you are having a heart attack, you should take an aspirin. It could save your life.

"They have us convinced basic sugar is bad for us and Nutrasweet is good for us..."

Sugar is bad for you, but I would eat sugar before I would use Nutrasweet, Aspartame, or anything else artificial. They are all very bad for you.

[spiritwalk]

I raised two kids and the only thing they got was Tylenol and lots of liquids. I don''''t even take anything other than Tylenol.
Posted by erasmus81
.............................................
I wonder about Tylenol. Once Tylenol came out the stories were rampant about aspirin killing children. When I was a kid we all got St. Joseph''s Aspirin for Children and we all survived.

So what happened to children''s aspirin? They changed the name to "Low-Dose" and told everyone they would die of a heart attack if they didn''t take it daily? Sounds like someone has been playing marketing games with otc medicine.

(And...what is Tylenol anyway? And why is it so much safer for children than aspirin? It''s like sweeteners. You ask the company what Nutrasweet is and they say...."Well, it isn''t sugar." They have us convinced basic sugar is bad for us and Nutrasweet is good for us, but they won''t tell us Nutrasweet is made of. They had the same "it''s better for you" line with Saccharin while they knew all along it was killing lab rats by the thousands. You can''t believe any of them)

[erasmus81]

I raised two kids and the only thing they got was Tylenol and lots of liquids. I don''t even take anything other than Tylenol. There are too many parents out there that are overdosing their kids. Either it''s because they want to shut them up, or it''s because they are too stupid to read a label. Either way, they are stupid.

And it isn''t just with cold medications, it''s with Vitamins, too. Parents think vitamins are harmless and kids think they are candy because they are chewable and fruit flavoured. I know of several parents that used to give their kids two and three a day. They would be getting way too much Vit.D and A. They aren''t water soluable like Vitamin C. And even Vitamin C can be toxic if you take too much.

[puzzler125]

My friends don''t understand why, when I have a cold, I don''t take Nyquil, nasal spray, OTC cold remedies, and just blow my nose, eat chicken soup, breath steam, and fill my humidifier. When your nose runs it''s your body trying to get rid of something. Masking the symptoms does not "fix" the problems caused by the illness. If you are sick don''t come to work and get the rest of us sick either!

[grammawhamma]

The danger I see with this is now some parents will try to guess what dose of "adult" medicine they should give to their child.

Kids that are prone to otits media can be helped by taking decongestants at the start of a cold to prevent ear infections that could require the use of antibiotics.

And since colds clear up on their own...then why even sell adult cold remedies?

[spiritwalk]

Anybody who has ever taken Nyquil knows that all it does is knock you out.

Cold medicine is not about curing the cold, just making you too stoned to care about being sick. (Most contain the ingredients they make meth out of)

You might as well give your kids a spoonful of brandy. It will accomplish the same thing.

[fabrat1]

Thats cause youre not giving them enough!
Stop reading the label...thats just a ''''suggested doseage'''' anyway!


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Posted by TheVicar1 at 01:05 PM : Oct 07, 2008



No thanks but you go right ahead if you want to put your kids life in danger.

[thevicar1]

I have raised 5 kids and most of the otc medicine doesnt work anyway ------------------------------------------------------ Posted by fabrat1



Thats cause youre not giving them enough!
Stop reading the label...thats just a ''suggested doseage'' anyway!

[fabrat1]

I have raised 5 kids and most of the otc medicine doesn''t work anyway. You''re doctor can get you something much better that''s a lot safer for your kids.

[mc_trump]

I think that anything that can be done to make kids feel better should be done.
I do not need the FDA the federal dumb _ _ _ association telling me what I can see for myself. When my child got a cold and her nose was running down to her knees. I gave her cold medicine and her nose stopped running, she stopped coughing and her fever went down ALL the PROOF that I needed.

I think that it has less to do with us having no patience and just not wanting to see our kids suffer. Also as far as that goes my mother had it so easy we started crying or fussing and whap she hit you with the doctor prescribed phenobarbital nighty night time you want to talk about lazy.

I think that parents should have the choice and I think that all this will do is make it so that parents will not know how much to give there child and there will br more problems.

[thevicar1]

LMFAO! guess well have to revert to the old tried and true remedy of a shot of sour mash with a juice box chaser ------------------------------------------------------ Posted by Osiod9


That should help a little...but what are you gonna give the kid???

[myopinion1]

Common sense prevails! Who ever gave their tiny children this stuff? Are you INSANE?

[credibility2]

The problem with many parents is that they haven''t any patience to properly raise their kids, including tolerating the natural healing process for common maladies and taking care of them diligently. Mny of today''s parents want quick fixes for everything. Taking care of one''s kids, which includes the difficult and often painful process of being there for their kid during a childhood illness, is something many of today''s parents are clueless about, disinterested in, or totally confused about executing.

[thevicar1]

Durn-it! Now Im NEVER gonna get that brat to shut up and go to sleep!!!