FDA: Cold Medicines Too Risky for Tots

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Hi everyone,

not sure if you've heard anything on this but I thought I would send it in case you need it.

FDA: Cold Medicines Too Risky for Tots

By LAURAN NEERGAARD

WASHINGTON (AP) - Parents may be left with only love and lots of liquid to give their sniffling babies and toddlers now that the government is declaring over-the-counter cough and cold medicines too risky for tots. The Food and Drug Administration was issuing that warning Thursday to parents of children under 2. It's a move expected for months: Drug companies last October quit selling dozens of versions of nonprescription cold remedies targeted specifically to babies and toddlers. That month, the FDA's scientific advisers also voted that the drugs don't work in small children and shouldn't be used in preschoolers, either - anyone under age 6.

The FDA still hasn't decided if OTC decongestants, antihistamines and cough suppressants are appropriate for older children, officials told The Associated Press. Expect a decision on that by spring, the deadline necessary to notify manufacturers before they begin production for next fall's cold season. For now, FDA's first official ruling focuses on youngsters under 2, warning that ``serious and potentially life-threatening side effects can occur.'' FDA is worried that parents haven't gotten that message despite all the publicity last fall. They may still have infant-targeted drugs at home, or they may buy drugs meant for older children to give to tots instead, said Dr. Ganley, FDA's nonprescription drugs chief. ``We still have a concern,'' Ganley said. ``It falls out of people's consciousness. We're still in the middle of cold season right now.''

Ganley was particularly struck by recent surveys that suggest many parents don't believe OTC remedies could pose a problem, especially if they've given them to an older child without harm. Thursday's move is a good first step, said Dr. Sharfstein, Baltimore's health commissioner. He petitioned the FDA last year to end use of nonprescription cold remedies by children under 6, a move backed by the American Academy of Pediatrics. The reason: There's no evidence that these oral drugs actually ease cold symptoms in children so young - some studies suggest they do no good at all. And while serious side effects are fairly rare, they do occur. Indeed, the Centers for Disease Control and Prevention last year reported that more than 1,500 babies and toddlers wound up in emergency rooms over a two-year period because of the drugs. ``It's one thing if you're curing cancer, but we're talking about a self-limiting illness,'' said Sharfstein. ``If there's really no evidence of benefit, you don't want to risk the rare problem. Then you're left with tragedy that you can't justify.''

Specialists are back to recommending old-fashioned steps, such as plenty of fluids and rest, saline drops to loosen stuffy noses, and humidifiers while sleeping. Why is this an issue now? Child versions of cold remedies came on the market decades ago, when scientists thought that what worked in adults would automatically work in children. Scientists today know that is not always the case. In fact, FDA never formally allowed infant-targeted cold remedies in the first place; Ganley said they evolved through a legal loophole. But the FDA is investigating an even bigger question: Are OTC cold remedies safe and effective for children under 12? The agency's advisers last fall called for no use just by the under-6 crowd, but did recommend more research to determine the medicines' effects in children overall. The drug industry says these medicines are used 3.8 billion times a year in treating children's cough and cold symptoms and are safe for those over 2.

Health groups acknowledge that while low doses of cold medicine don't usually endanger an individual child, the bigger risk is unintentional overdose. For example, the same ingredients are in multiple products, so using more than one for different symptoms can quickly add up. Also, children's medicines are supposed to be measured with the dropper or measuring cap that comes with each product, not an inaccurate kitchen teaspoon. An internal FDA working group has a February deadline to recommend to agency leaders any action for 2- to 11-year-olds, Ganley said. The goal is a spring announcement. Meanwhile, the FDA's advice for children over 2: If you try these drugs, carefully follow label directions. Avoid giving a child more than one product. If you do, make sure they don't contain some of the same or similar ingredients. Understand that these drugs only treat symptoms. Colds are viruses, and the drugs will not make them go away any faster.

01/17/08 08:19 © Copyright The Associated Press. All rights reserved. The information contained In this news report may not be published, broadcast or otherwise distributed without the prior written authority of The Associated Press.

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[Guest guest]

I heard Sanjay Goofta talk about it on CNN this morning. He said cold meds may not work for kids as old as 10 years old. But, right now it’s 0-2 years. They are going to do more tests.

On 1/17/08 6:34 PM, " Dad Fourkids " <dad_4_kids@...> wrote:

FDA: Cold medicines too risky for tots

http://news./s/ap/20080117/ap_on_he_me/cold_medicines

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[Guest guest]

I heard Sanjay Goofta talk about it on CNN this morning. He said cold meds may not work for kids as old as 10 years old. But, right now it’s 0-2 years. They are going to do more tests.

On 1/17/08 6:34 PM, " Dad Fourkids " <dad_4_kids@...> wrote:

FDA: Cold medicines too risky for tots

http://news./s/ap/20080117/ap_on_he_me/cold_medicines

__________________________________________________________

Looking for last minute shopping deals?

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[Guest guest]

A quote from the article below: The FDA still hasn't decided if OTC decongestants, antihistamines and cough suppressants are appropriate for older children, officials told The Associated Press. More BLAH, BLAH, BLAH!!! My kids' pediatricians (even the ones we encountered at the after-hours clinics) all sing the same song, that over-the-counter cold medications are worth diddly-squat in combatting viral infections. Some years ago, at one of these after-hours clinics, I happened to run into a doctor who had taught our pediatrician many years ago. He, of all the doctors I have come across in recent years, was the most vehemently opposed to over-the-counter cold medications. He basically told me that they were useless. Since then, I have tried to use less of these "medications" with my kids, more vitamins and supplements along with healthier foods, and lo and behold, they seem to be doing better for the

most part. After close to 20 years, this Christmas was the first holiday season that our pediatrician sent our family a holiday greeting. Perhaps he "misses" us, since we have not needed to see him much over the last several years. Aasa Dad Fourkids <dad_4_kids@...> wrote: FDA: Cold medicines too risky for tots http://news./s/ap/20080117/ap_on_he_me/cold_medicines__________________________________________________________Looking for last minute shopping deals? Find them fast with Search. http://tools.search./newsearch/category.php?category=shopping

[Guest guest]

"Sanjay Goofta"? Are you sure it's not "Sanjay Goopedup"(i.e., entangled with the spinmeisters)? Just wondering,.... (On occasion, he does have something worthwhile to say, but more often than not, I feel like clobbering him "gently", despite his good looks,...I know he is smarter than the garbage he delivers at times). Aasa (P.S., I hope this won't land me in any more hot water than I already am, elsewhere in cyberspace).christine <christine@...> wrote: I heard Sanjay Goofta talk about it on CNN this morning. He said cold meds may not work for kids as old as 10 years old. But, right now it’s 0-2 years. They are going to do more tests.On 1/17/08 6:34 PM, "Dad Fourkids" <dad_4_kids > wrote: FDA: Cold medicines too risky for tots http://news./s/ap/20080117/ap_on_he_me/cold_medicines__________________________________________________________Looking for last minute shopping deals? Find them fast with Search. http://tools.search./newsearch/category.php?category=shopping