October 20, 2007

Drug Deal: What Infant Medicines Are Included In This Whole FDA Ban Thing?

As DT reader Gromit pointed out yesterday, there's something of an "information void" about what medicines and active ingredients are included in the drug industry's recent voluntary withdrawl of cold & cough medicines for 0-2 year-olds, and what medicines the FDA's advisory panel recommended banning for all kids under 6yo.

The medicines in question are generally described as over-the-counter cough and cold medicines for infants and children; that much is clear. For more details on what's included and what's not, click below. One key point to remember: pain reliever/fever reducers like acetaminophen and ibuprofen are NOT on the list.

Last week, the Consumer Health Products Association, which includes all the major drugmakers, published a list of all the infant medicines being withdrawn, sorted by brand name. There are 14 products on the list [source: chpa-info.org]:

* Dimetapp® Decongestant Plus Cough Infant Drops
* Dimetapp® Decongestant Infant Drops
* Little Colds® Decongestant Plus Cough
* Little Colds® Multi-Symptom Cold Formula
* PEDIACARE® Infant Drops Decongestant (containing pseudoephedrine)
* PEDIACARE® Infant Drops Decongestant & Cough (containing pseudoephedrine)
* PEDIACARE® Infant Dropper Decongestant (containing phenylephrine)
* PEDIACARE® Infant Dropper Long-Acting Cough
* PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine)
* Robitussin® Infant Cough DM Drops
* Triaminic® Infant & Toddler Thin Strips® Decongestant
* Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough
* TYLENOL® Concentrated Infants' Drops Plus Cold
* TYLENOL® Concentrated Infants' Drops Plus Cold & Cough
The FDA Advisory Panel's briefing document for the 10/19/2007 hearing [discussed here, published here] opens with the following:
[p. 4] OTC cough and cold products are widely marketed and used by parents to treat children with symptoms of the common cold. They are available as either single ingredients or more often as combination products containing one or more of the following: nasal decongestant, expectorant, antihistamine, cough suppressant, and also an analgesic and fever reducer [emphasis added]
So yeah, some combination cold medicines containing analgesics and fever reducers are on the line. But not single ingredient analgesics or fever reducers.

This whole ban/review process was begun in February when pediatricians from the Baltimore City Health Department filed a petition. Here's what they wanted reviewed--and banned:

[fda, p. 13] In the typical drugstore, over 30 separate cough and cold preparations are marketed to parents for use in children. Products advertised for use in toddlers and young children are typically liquid formulations or chewable tablets. There include dextromethorphan and guaifenesin for cough as well as chlorpheniramine maleate and phenylephrine for nasal congestion.

Other products are labeled as "infant" formulations, display images of babies and infants, and include oral droppers or syringes to dispense medications to children too young to drink from spoons or cups. Examples include products containing acetaminophen and phenylephrine market for coled; products containing dextromethorphan and guaifenesin marketed for cough.

Interestingly, the petitioners don't mention pseudoephedrine in their intro [though they do cite several infant deaths caused by pseudoephedrine overdoses probably caused by multiple doses of combination medications.]

And finally, on pages 27-28, there is a pediatric dosing table of "antihistamine/antitussive/nasal decongestant commonly used ingredients" which includes:

Antihistamines
Brompheniramine Maleate
Chlorpheniramine Maleate
Diphenhydramine Hydrochloride

Antitussive
Codeine [whoa, really?]
Dextromethorphan
Diphenhydramine Hydrochloride

Nasal Decongestant
Pseudoephedrine
Phenylephrine Hydrochloride

I think these eight active ingredients are really the beginning and end of the FDA's discussion. Am I missing something? Definitely let me know.

11 Comments

Wha? You people had codeine kids cough syrup?

The important part is, parents can still dose their kids with benadryl to make them sleep on the plane. (I am totally kidding! I would never do such a thing! I use Gravol for that)

Working in the ER, I have found that many parents try a number of remedies to help with their children's cold symptoms. Frequently parents try two or three preparations in order to help quell a cough at night.

We've always told parents that cough medicines are not effective, and may lead to more harm because of the large amounts of antihistamine and tylenol(in some preparations). Depending on the size of the infant... they can easily reach a toxic level of tylenol in their system (ie they were dosed with plain tylenol and then redosed within 4-6hours with a cold medicine containing tylenol). Suppressing a mucous-mobilizing cough can lead to a pneumonia (since the mucous never gets a chance to get "coughed-up").

Antihistamine ODs can lead to confusion, weakness, dry mouth, flushing, fever, hallucinations, and possibly seizures. In general, I think the medical community is concerned about parents who haphazardly dose their children and the overall confusion as to what is an appropriate medication for infants/toddlers.

While taking these meds off the market is frustrating to some parents, I feel that the FDA is doing a great service. I think that most of these pharm companies take advantage of parents' concern and market a product that is ill-suited for the most vunerable in the population. Just my two-cents. BTW, codeine is a great cough suppressant. It is a narcotic that suppresses the cough reflex.

[codeine4kids appears to have moved to prescription-only, for chronic cough. -ed.]

I think it (the information void) goes beyond just the list of what's going away and what's still available... I suppose it's a bit early, but I haven't seen any of the groups who've been asking for a ban put forward any useful information to help parents figure out what to do. I think if you were to tell parents why the ban is necessary, back it up with this info, and THEN explain to them what they CAN do to help their sick kid, they'd have a much easier time processing this information.

g

Gromit,
The thing is that information is available and it has been available for years. It's just been far easier for parents to go to the drugstore and purchase a box that pretty much says right on it "this is for your kids cough" than to do the research so the parents don't.
There are dozens of things you can do for your child when they are sick that don't involve giving them medicines. I don't use cold medicines for myself because they make me sick to my stomach so I have tried each of these even on myself and they work wonders.
- If your child has a horrible cough, turn on the shower in your bathroom and sit in there with them in the steam. They even sell shower vapor things now to ease nasal and chest congestion.
- An older child (old enough to use a pillow) can be propped in a more upright position when they sleep.
- Use humidifiers in their rooms
- warm teas work well
- for children over the age of 1 use a warm mixture of honey and lemon juice for a cough
- use a small dab of mentholated (sp?) chapstick or rub under the nose to ease stuffiness and prevent chapping from runny noses
- Chamomile tea (just a little for kids) is great to ease upset tummies caused by drainage and coughing and it helps a child sleep

It's not that the information isn't available. Everything I listed is a really simple solution and they cost less than cold/cough meds too.

Rachel:

yeah, I know there are lots of places to find suggestions on your own, but that's not quite what I'm getting at. Any parent that wasn't even aware there was a controversy has about the same reaction - "well NOW what am I supposed to do?!" -and the TV news reports I've seen have definitely taken advantage of it. They feel a bit like the rug's been pulled out from under them, and I can't blame them. The AAP currently has a sidebar on their homepage that links to a statement about the withdrawal of cold medicines, but clicking through takes you into a few pages that feel a bit like a mishmash of the old and the new.

The organizations calling for a ban have stepped forward as the experts in the field looking to change current practice. While I'm in full agreement with them and I'm glad to see this happen, I'd be more impressed with their action if they themselves - speaking as experts in the field - would make a clear statement that included what parents can and should do instead. Read what the AAP has on their site today, though, and you could easily be confused about whether or not these drugs are ok to use.

Greg's absolutely correct that many parents will end up doing whatever seems right to them, and some of those ideas could be at least as harmful or risky as the products withdrawn from the market.

g

Gromit,
Now that I've seen the actual AAP sight I definitely get where you're coming from. It really isn't helpful to click on a link that says it will show you other ways to treat your child's cold symptoms and end up at a link that tells you not to use cold/cough medicines and doesn't give any suggestions.
Granted it's not rocket science... it's confusing.

I will tell you that I've never been a fan of the AAP and I often find myself wondering if they really do their research. My mom took my goddaughter to her one year appointment and before she even weighed her she said "Okay she's 1 so you can turn her carseat forward facing now." She said this because that's what the AAP tells her to say. Well she only weighed 18 lbs. and no, if she'd read up on studies she'd know that a child should rear face as long as absolutely possible (she still does at 15 months and will for a LONG time).
At my godsons 3 year appointment they handed her a sheet of paper that said he could move to a booster seat... again NO! He's too small and he's not yet 4 which they'd know if they read the studies.

My point. Sometimes I think the AAP just sits around and lets everyone else do the work for them. Then they pull on the slightest bit of information they gain and stick that into their information. They hear that children should forward face before age one but they fail to give parents the advice they need to keep their children safer longer. They hear that children shouldn't take cough or cold medicines but they fail to give the advice on what parents CAN do to make their children feel better.

It's pretty sad really.

[I have to add my own skepticism, at least about total reliance on the AAP. Our pediatrician's office is at a teaching hospital, so we get extra doses of "the only website you should look at is the AAP" whenever I mention the word "online," even if it's followed by a specific source or accompanied by a printout. I can totally understand MD's going crazy trying to deal with this invisible, amorphous second opinion that is the web, but there is never even the slightest recognition granted to citations of AAP-level sites--never mind an acknowledgement that patients or parents might be intelligent partners in the process. -ed.]

That last part should say
"Children SHOULDN'T forward face"

Here in the Netherlands, it's not only impossible to get cold medicine for children, but also for adults. Trying to get anything with more than paracetamol and vitamin C without a prescription is basically futile. You can also call you GP to ask for a stronger dose of flu medicine, and s/he'd tell you to stay home and sleep a lot instead. My kid is 18 month, and had a cough + flu since last week. The doc simply said that unless her fever doesn't come down in three days, to just let her immune system work by itself. Annoying? Yes. But in the long run she does get sick less and less frequent as she gets older as I notice.

It sounds like somebody just needs a different pediatrician. I never had one tell me to turn around an under 20 pound child.

I'm not a knee-jerk fan of the AAP (I was not at all keen on their anti-co-sleeping statements), but I do have a lot of pediatricians in my family and I recognize that it is hard to get ANY group to come to consensus on these issues, but maybe even more so with pediatricians. One of my pediatrician relatives thinks it is OK to give her kids benadryl on long trips, others think she has lost her mind. And that's just in a group of half-a-dozen or so.

I'll definitely agree that they need to put in some more time on their web site though. It's hard to even find the good information.

Mom2_2

She intially began the appointment by telling my mother that because Caydee was 1 she could be turned forward facing in her carseat. I'll give her the benefit of the doubt because not very many 1 year olds weigh under 20 lbs. and to her credit she did correct herself after the weighin, saying she'd need a few more weeks of growing (try another year, or two!) before turning her around.

But I think the point is, it's sad that there have been SO many outstanding studies done that the AAP won't even regard. It's great that they agree you shouldn't turn a child around before they're 1 and 20 lbs, but try telling a pediatrician you're going to keep them turned around longer, it seems almost universal the response you'll get and it isn't positive.
The pediatrician says, "They could break their legs in an accident"... and when you reply, yes but a broken leg is better than a broken neck! They fall silent. I've heard it before and I've said it before -- and I've heard of many other parents recieving the same response.
It's a sad lack of information.
And as Greg said, pediatricians often aren't willing to allow parents to be partners in their children's healthcare.

Its all BS.. there is no way I am going to let my grandchild suffer because the FDA is up their own ass. I ve reared 3 kids with dextromathorphan and its only done what it was to do. My grandchild was miserable and just one dose and he was a completely change child. all the symptoms subsided and that is a fact. The FDA needs to get their act together.

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