FDA Being Told To Remove Children's Cold Medicine

[Aelwynn]

http://www.komonews.com/news/health/30109714.html

WASHINGTON (AP) - With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids' coughs and sniffles. Doctors question the drugs' benefits and worry about their risks.

Pediatricians are urging the Food and Drug Administration, which scheduled a public hearing Thursday on the issue, to demand a recall of the medicines for children younger than 6.

"Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," said Dr. Joshua Sharfstein, Baltimore's health commissioner. "There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6."

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.

The FDA this year warned 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.

The industry says OTC medicines have been used for decades in treating kids' colds and are safe for those older than 2. Nonetheless, manufacturers are carrying out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.

FDA advisers said that was not enough and recommended that the drugs not be used for children younger than 6. An expert panel said older children could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.

It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.

Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.

But Sharfstein said Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.

I don't know about you all, but this is about my kid's health. If I feel the need to give them medication when they are really sick, I should be allowed to do that. As for these accidental overdoses, it's not hard to follow the instructions. If some people aren't doing that, it's because they are retarded parents.

My 3 month old daughter has a bad cold now. She's been sick for a good 4 days coughing so much she wakes herself up. She had a fever the first two days, I finally got that back down.

It took me 5 HOURS to find a store that sold baby tylenol. You know the kind that the FDA removed from stores saying that it causes kids to stop breathing...yet was later found to not cause any problems. It still hasn't really been put back on the market.

It's a little fucking insane that I need to take my kids into the hospital for a simple cold that would be fixed with rest and MAYBE a little medication. I don't dose my kids a lot, but damn..when I need to, the FDA screws it up for us all. Oh and whoever gives their kids 2-3 different kinds of medications without reading the labels should be slapped. There is Baby Tylenol for colds, congestion, coughs, and fevers. It works for all of the above. Don't be cheap, get the good stuff and stop overdosing kids! ;P

Now they wanna tell us what to do for kids under 11?! Come on, it's bad enough they control everything for 3 and under..now 11 yrs old too?

Comments, thoughts, opinions?

[crickett]

My younger daughter had constant respiratory and ear infections for the first YEAR of her life. She also had colic. She DID see a pediatrician about EVERY 2 - 3 WEEKS. She was constantly miserable and would NEVER have rested without childrens tylenol and gas medications. Now they would expet me to WHAT???? Take her to the ER EVERY SINGLE NIGHT OF THE WEEK TO GET TYLENOL AND GAS MEDS???? Heeelloooo....that is NOT practical. I, and most people, are able to follow directions on the bottle. MOST people know enough to call their pediatrician if in doubt about mixing medications.

The only thing that I WOULD suggest. Place the childrens Tylenol in back of the pharmacy counter as they now do with sudafed and a few other meds. That way one would have to talk to a pharmacy staff member. That way they could be ASKED what other meds their child(ren) is/are on, age and size of the child, etc. Then, this would be the ideal time to give them a pamplet with directions for children and covering the areas of concern.
I do NOT believe that there is any advantage to simply pulling these meds off the shelf. A lot of little ones will needlessly suffer if this is done.

[Ruby]

This is so friggin' ridiculous it makes me want to scream. They say there's no proof these meds even work for kids under 12. All they have to do is call me. My kids take cold meds and THEY WORK. Always have.

The reason so many kids end up in ERs is through misuse/misdosing/overdosing by idiot parents. The typical scenario is that the parent gives a child what they think is "cough medicine" when it is, in fact "cough and cold." 20 minutes later, parent decides their little pookie-pie is also stuffy, so doses them with a decongestant, which was actually included in the first med. So little pookie-pie is overdosing, and winds up at the local ER with rapid heartrate and breathing problems.

Does that mean the medicine is evil? No, it helped my kids through many a bad night.

So how about we focus on parental education, CLEARER labels, multilingual labels. How about we even do away with the "combo" drugs for children. I'd be willing to get behind that. That would eliminate a whole host of confusions. There could be COUGH, DECONGESTANT, PAIN RELIEVER, and ANTIHISTIMINE. None of them could be combined in a single medicine with any other. Each stands alone. Frankly, I'd rather a kid had to down two doses of different meds than risk anyone OD'ing.

Idiots.

[Aelwynn]

I agree, most of the problem is related to people not reading frickin labels. I'm not going to go to wait in the ER (pediatricians office is same building, same line) to wait to get cold medication from the woman that think's her kid is awesome. I dislike our pediatrician to a huge extent, and most of them on base have no idea what to do with kids except the standard "are they eating enough?"

Last time I took my daughter in for a 101 fever, I was told she could be autistic?? I flipped out it for months until I saw another THREE specialists that told me the woman was nuts. Now, they want to take away cold medications becaue some tards out there don't know how to read a bottle.

I know the baby's tylenol works for my girls, I give them a drop or two drops once every 8 hours if needed. If I don't think they need it, I don't give it to them. Simple colds I don't give it to them. Serious fevers, I do. A major fever can cause brain problems if not taken care of immediately.

While I'm all for taking care of the kids and making sure they are healthy, I can't help but think the FDA is going a little overboard on this one. Jumping the age up to 11 yrs old is also insane. Now they are going to tell people what they can and cannot do with their 10 yr olds. I think that's a little insane.

I'm all for educating people that don't know how to properly medicate their kids, but what about those of us that do know how to medicate our kids safely? This is kinda a slap in the face. Why take away the medications completely instead of what Ruby suggested? Just educate and clearer labels.