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October 19, 2007

DT Wonkout: FDA Panel Votes To Ban Cold Medicines For Kids 0-6 [Yes, SIX]

Well it was an awkward day for the infant cold medicine-hoarding MBA's in the house, let me tell you. The FDA's joint advisory commitees for non-prescription drugs and pediatric medicine met today to review and vote on a petition to ban OTC cold and cough medicines for kids. The result: a near-unanimous vote [21-1] to ban the meds for infants and kids 0-2, and a closer vote [13-9] to ban them up till age 6.

The same drugmakers which pre-emptively withdrew their products from the 0-2 market last week said they'd fight the 3-6 ban recommendation.

The NY Times has a summary article on today's hearing, but it feels pretty thin, fact-wise. I barely looked, but couldn't find any liveblog accounts of the meeting, which was open to the public, but I did find the official FDA paper trail leading up to the meeting, which has a health policy wonk's paradise worth of petition support; research summaries; market data and trends (broken down by age and drug); and additional opinions and data from the drugmakers, poison control centers, the American Academy of Pediatrics, and other interested parties. The briefing information alone runs 356 pages.

You know what, reading through it is actually changing my point of view. The opinion letter from the AAP President Dr. Jay Berkelhammer is especially persuasive. It starts on page 325 of the briefing document pdf. I can't find it online, so I've typed in a few of the most unequivocal excerpts below.

Suffice it to say, after reading through maybe a quarter of the briefing data, reviewing several studies showing the ineffectiveness of the ingredients in these medications [which is definitely not the same thing as a lack of data showing effectiveness], and seeing some much larger numbers for potential overdosing and combination drug overlapping, I'm seriously questioning my previous "eh, the meds are alright" stance.

F.D.A. Panel Urges Ban on Medicine for Child Colds [nyt]
Center for Drug Evaluation & Research 2007 Meeting Documents - Non-Prescription Drugs [fda.gov]
Briefing Information: FDA Joint Meeting - NPD & Pediatric Medicine, October 18-19, 2007 [fda.gov]
Just one study referenced in the AAP President's letter:
Paul IM, Yoder KE, Crowell KR, et al. Effect of Dextromethorphan, Diphenhydramine, and Placebo on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents, Pediatrics 2004;114. [pediatrics.aappublications.org]
Previously, i.e., last week: DT: currently hoarding infant drops, overdosing on dosage information

[Below are some key excerpts from the AAP response to FDA-ONP's inquiry about pediatric use of cough & cold medicines. The letter is from the AAP President, Dr. Jay E. Berkelhammer, MD, FAAP, to Dr. Joel Schiffenbauer, MD, Deputy Director of the Division of Non-Prescription Clinical Evaluation at the FDA-CDER-ONP. (got that?) It's dated Sept. 6, 2007, and can be found in its entirety, including references, on pp325-9 of the FDA's briefing document. ] [Begin quote, emphasis added]

...the following commetns are directed toward the qutsions posed in your letter:

1.a. We are interested in the opinion of the AAP on the labeling that would be appropriate for OTC cough and cold drug products for children.
Appropriate labeling should reflect the evidence-based benefits of the use of these products in children, the risks associated with their use, and accurate dosing information so that children's health care proiders can make an informed decision as to whether or not to recommend use of these products and counsel parents appropriately should they choose to do so.

1. As for the efficacy of these compounds, the published literature on the benefits of these preparations does not support their use in children at this age. Not only have these products "not been found to be safe or effective in children under six years of age for the treatment of cough and cold," as is stated in the petition, but also, they have (with the exception of pseudoephedrine, for which there are no pediatric data) been found not to be effective in this population at all. This distinction is an important one. This is not a situation in which pediatric data are lacking and we are unable to say one way or the other whether or not these products work in children. Multiple peer-reviewed studies have concluded these medications and combinations are not effective at the currently recommended doses in children. The AAP, American College of Chest Physicians, and Cochrane Collaboration have reached the same conclusion.

As for the risks, these products are generally well tolerated in children when given in accord with labeling. However, there are at least two important situations in which children are placed at greater risk of the serious adverse events described in the petition.

The first of these relates to the frequent misdosing of these preparations. The OTC cough and cold medications and anithistamines were the sixth and tenth most frequent exposures in children under six years of age reported to US poison control centers in 205, accounting for more than 100,000 cases. The 1998 pediatric data from teh American Association of Poison Control Centers (the most recent published set to break out pediatric data on children under six years of age) demonstrate that 15% of the children received an inappropriate dose of these medications and required treatment. COntributing to this problem is the availability of multi-ingredient preparations that could lead to inaccurate dosing as a result of a caregiver misunderstanding the active ingredients when administering m ore than one preparation. For example, a "cough and allergy" preparationmay contain the same ingredient as one labeled as "chest and nasal congestion." This is made even more complex by the variability in titles given by different manufacturers.

The second source of risk is the complete lack of data to support a therapeutic rationale for dosing in the pediatric population. When parents are advised to "consult with a physician" for the appropriate dose of these preparations in their infant or young child, they expect that the physician has access to evidence-based information on which to base a decision, but this information is nonexistent. Furthermore, the need to consult with a physician is inconsistent with the classification of these medications as OTC. The prescription exemption procedure classifies OTC medications as those that are "safe and effective for use in self-medication as directed in proposed labeling." Reuireing parents to consult their physician for a dose in their infant or child represents an unacceptable shift of responsibility for proper dosing from the manufacturer to the physician, who, given the current absense of data to show that these medications even work, has no rational basis for their dosing.

The potential for inaccurate dosing is further exacerbated by the apparent greater sensitivity of children under the age of two years to the potentially fatal effects of some of the more common ingredients in these preparations... [ed: ?!]

[End quote]

In the letter Berkelhammer and the AAP go on to recommend very strongly worded caution labels on the medications, which can be revised as necessary as data comes in. In addition, he criticizes as "common but fraught with danger" the practice of extrapolating efficacy data from adults for kids. As the AAP sees it, the variability and changes taking place in growing kids make this extrapolation process inaccurate and potentially dangerous.

It's worth pointing out that several DT commenters have made these and similar points before, though not with direct citations that I can recall. It's not that I didn't believe you; it's just that, as far as I know, you weren't the president of the AAP.

posted October 19, 2007 11:13 PM | add to del.icio.us | digg this


Thanks for the links and choice quotations, that's very helpful.

I'm still a little confused: are single ingredients alone efficacious in children (i.e. decongestant or cough suppresant) or does none of it have any effect?

Did you notice the headline in the Times this morning: Moms Split over Medicines -- Dads apparently have no opinions whatsoever, or their opinions don't matter!

[d'oh, I haven't seen it yet. But I assume the dads are probably hoarding, since everyone in the world is just like me. heh -ed.]

posted by: Michael at October 20, 2007 9:54 AM

I whole heartedly agree with the banning of the infant/toddler cold medicines. As for going up to age 6... it seems pointless to me. They will still have to make children's cold medicines for children over the ages of 6 so I don't believe parents will follow that.

As for whether or not cold and cough medicines work. I can't say from expert advice, but from personal opinion and experience working with tons of different children at different ages, they don't. That's not to say that cough suppressant doesn't suppress a cough... but it's to say that I don't believe it's the medicine part that does it. We have only given Connor (3) cough medicine a couple times. Sure it helped him sleep and soothed his cough but I'm not fooled in thinking the medicine part of the medicine that did it. Now he just gets honey with lemon juice and it works just as well. Cough syrup soothes the bronchial tubes and when they are less irritated the child coughs less, it makes sense.

As for decongestants, the only time he was given a "decongestant" by his pediatrician he had a horrible reaction to it. He was out of control one second and then laying in a heap on the floor the next. He would run into walls and bang his head on the floor and stare off into space. It was awful. We called the pediatrican who said it wasn't an "abnormal reaction" but we should go ahead and take him off them. He will never take one again.

[the results from the 2004 Pediatrics study linked above say, "For the entire cohort, all outcomes were significantly improved on the second night of the study when either medication or placebo was given. However, neither diphenhydramine nor dextromethorphan produced a superior benefit when compared with placebo for any of the outcomes studied. Insomnia was reported more frequently in those who were given dextromethorphan, and drowsiness was reported more commonly in those who were given diphenhydramine." -ed.]

posted by: Rachel at October 20, 2007 11:29 AM

My 3-year-old was sick yesterday and was moaning with a 102 fever in the middle of the night. We dosed her with acetaminophen and her temperature came right down. This is the same stuff she would be dosed with if we took her to see a doctor.

Is the end result of this legal footwork going to be that every time our kids get a cold we either #1 pay for a doctor visit to get a prescription, or #2 let the kid suffer the symptoms and pray for a swift miraculous recovery? I foresee parents forming an illegal drug trade and FBI raids on preschool ringleaders.

[acetaminophen for infants or toddlers is not on the table. it still works and is staying around. It's the decongestants, antihistamines, and cough suppressants that are the issue. I was all set to be the leader of the dimetapp underground, and I'll probably keep the dosage info we've downloaded from Dr. Sears online, for future reference. But I think people will start using non-drug remedies, or they'll start eyeballing it and give their kid tiny doses of adult medicine. Or brandy. And then just hope they don't go into shock or whatever. It'll take a long time to change behavior and expectations. -ed.]

posted by: AJ at October 20, 2007 11:47 AM

To answer Michael's question... no, even single ingredients are considered ineffective, and not from lack of trying to document an effect through clinical trials. Turns out they (cough suppressants, expectorants, antihistamines) work about the same as placebo.

Can we start a discussion on placebo suggestions?


{strawberry daquiri, does that count as a placebo? -ed.]

posted by: gromit at October 20, 2007 11:48 AM


Acetaminophen and ibuprofen are not included in these "cold remedies", other than they could be contained in some of the multiple-ingredient products. Those two are great options for reducing fevers, especially for an uncomfortable kid (moaning), and won't be affected at all by this ban.

Still though, we're stuck in a little bit of an information void - I haven't seen anyone spelling out details like this (what's *not* included in the ban).


[now that the kid's pumpkin party is done, I'm trying to pull together the specific active ingredients being considered for the ban. Here's the list of 0-2yo medicines that were withdrawn, though -og.]

posted by: gromit at October 20, 2007 11:55 AM

"...and drowsiness was reported more commonly in those who were given diphenhydramine."

Wait, doesn't that mean it *is* working?

posted by: Matthew Miller at October 20, 2007 5:46 PM

Thanks Gromit. The information has been confusing: first a lot of talk about parents who overdose, then no proof of efficacy, now proof of non-efficacy. I wonder how good the data is for adults with this stuff.

I think the solution is to start marketing some very appealing placebos. Chocolate-Ice-Cream Pills for example. They would be much safer than current meds, and have the same powerful placebo effect.

posted by: michael at October 20, 2007 7:54 PM

I think we should be honest about what really drives decongestant/cough syrup sales; sleep-deprived parents desperate for anything that will make their sick infant sleep. The drowsiness for a lot of parents isn't a side effect...it's probably the biggest benefit. The medicine justifies it.

And I'm outing myself in saying, yeah, my motives for wanting to administer baby medicine have also not always been 100% pure. I've had to resist temptation to resort to it on many occasions.

Awful, isn't it? Our grandparents used whiskey and patent medicines with alcohol for the same reasons. We've changed that, but the problem for the parents remains. I'm no sure what the answer is unless we want more guaranteed sick leave or something.

[It's a huge, good point to make. A survey somewhere in the FDA story mentioned something like 71% of parents have given their kids medicine to get them to sleep, which is phenomenally high, I think. Though we, too, have done it a couple of times, it's something that people joke nervously about, then cop to, then change the subect on, I think. -ed.]

posted by: emjaybee at October 20, 2007 10:19 PM

Honestly, I'm not sure what there is to be ashamed of. The "medicines" in discussion all target symptoms anyway -- it's not like they would actually help with a cold even if they worked. On the other hand, a good uninterrupted sleep gives the body a chance to recover.

[so in the interest of not over-medicating, we just need to a couple of great, kidsafe sleeping pills. Enough with the designer drugs for aging baby boomers--Levitra, I'm looking at you--let's get some useful drugs for OUR generation! -ed.]

posted by: Matthew Miller at October 21, 2007 7:36 AM

I would certainly like to believe that the meds relieve the symptoms which then promote a better night's sleep… That said, and hinging on the coattails of the point that the meds in the spotlight don’t cure the sickness, just help (allegedly) with the symptoms, I’ve always felt that the best thing for the child is to get solid rest and let the body do its thing…
Unfortunately, it’s a dark little twist of nature to watch a newborn with plugged sinuses--too young and inexperienced to know that she needs to keep her mouth open to be able to breath--constantly jolt herself awake as if suffocating, yet staying asleep is exactly what is needed. Then to add insult to injury, the parents don’t get any sleep either loosing capacity to properly care for the offspring… Hopefully natural selection will help this process along some, give us an edge over cold like symptoms.
BTW, thanks for all the info… Excellent backup, and good editorial!
One last topic for discussion: Screw group based clinical studies. I think pharms. should focus on safe doses and a list of ailments POSSIBLY addressed by each of their potions. Each individual is different. Let the masses do a little individual clinical trials and determine for themselves. I can assert that Tylenol does NOT do a single thing for me. I might as well eat M & Ms… Advil on the other hand, is almost as good as a recreational drug for me (not that I would know of course). To really put it in perspective, I lost a piece of a toe in a lawn mower accident, and was basically pain free with 600mg of IB (3 Advil).

posted by: Andrew Phipp at January 2, 2008 12:43 AM
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