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More on Children's Cough Meds

According to a front page article in the Washington Post, an FDA panel voted 13 to 9 to recommend against the use of over the counter cold medications in children less than age 6.

Is there some genetic transformation between the 2190th and 2191st day of life that makes someone less likely to have adverse effects from these medications? Or is the panel just drawing arbitrary lines in the sand at age 6?

I think the reason they made this arbitrary age is because everyone on the panel has kids that are older than age 6, so they don’t have to worry about treating colds in their kids any more.

Here’s an interesting factoid: According to the Washington Post article, Mary Tinetti, MD of the Yale School of Medicine is the doctor who chaired the FDA panel. Mary Tinetti is also Chief of the Division of GERIATRICS at Yale. She is the Director of the Claude D. Pepper Older Americans Independence Center. Her interests are in fall injury risk prevention and geriatric health problems. All of this is obviously germane to the effects of children’s cough and cold medications. In fact, she must have a lot of experience with 6 year olds — maybe when they come to their grandparent’s doctor’s appointments and are all strung out on cold medications.

If I were asked to be on a panel with Dr. Tinetti’s qualifications, I would decline because of a lack of experience with the subject matter. Why did she accept the appointment?

If your kids are sick this winter and you want to get an FDA expert’s opinion, you can contact Dr. Tinetti at the link above.

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  1. In an interesting but typically bureaucratic paradox, this decree is probably going to cause even MORE overdoses of cough medications in younger children, because instead of knowing the proper dose of medication to administer, parents and physicians are going to have to improvise.

  2. Nearly 100% of my patients would say that these medications are not ineffective. I have used them on my kids and did see more than a placebo effect. I honestly think that this kind of stuff does damage to the credibility of the FDA. It is as if they came out and said suddenly that Milk was not healthy and should be avoided.

    Yes, I know the research. I just have a ton of disdain for the ivory tower folks. This is causing far more trouble than good. How widespread was the epidemic of kids dying from Dimetapp?

    On the other hand, I can see the trial lawyers getting excited. Well, there’s a good thing!

  3. I am glad you docs discuss these things and bring another perspective to light.

    When I was first getting stented in winter of 2006, I developed an e-coli infection when I had the big stent in me. I became resistant to all the antibiotics the doc was prescribing and so he admitted me so that I could be put on Rocephin to knock the infection out before going in to OR to remove the stent. I could be wrong…but I think it was Rocephin. Anyway, my point is I hate to see good drugs messed with for financial gain. Obviously research is important and if something needs correction or improvement – then do it. But, one would hope that integrity prevails.

  4. Hey, look at her research. She has found the answers to why your elderly patients are “weak and dizzy”.

    Annals of Internal Medicine 312:337-344, 2000

    Her research concludes “Dizziness is a common symptom among older adults living in the community. Dizziness in an older person often seems to be associated with a combination of other medical conditions and with the medications a person is taking rather than the result of a single underlying disease. ”

    About as helpful as her gait and balance assessement tool. I can watch a pt walking in my exam room and getting on the table and determine if their gait is unsteady without having to use a 2 page questionnaire.

    Too bad she didn’t have the sense to decline chairing this committee.

  5. Dr. Rob,

    At your own blog you write: “These medications are clearly proven in scientific studies to be ineffective. Plus, there is the issue of over-use and potential harm. I understand all of that. Yet my patients don’t believe these are ineffective. I gave them to my kids and they seemed to work.”

    The obvious question is why are you not educating your patients about alternatives instead of allowing them to take useless and harmful drugs? Yes there are alternatives. See: http://givingupcontrol.wordpress.com/2007/10/04/after-the-ban-on-children%e2%80%99s-cold-medicine-what-you-can-do/

  6. The FDA is finally acting on what studies have shown multiple times: OTC cough/cold medications just don’t work in kids for whatever reason. Several sytematic reviews from the Cochrane databases as well as the BMJ, and articels in J. Peds as well as pediatrics have all shown there is little clinical effect from these medicines when studied in large populations. Your own mileage may vary. Doesn’t mean they dont work in everyone or anyone.

    There is no “dying from dimetapp” epidemic but there are real cases of abuse of dextrometorphan/coricidin to get high as well as folks using psuedoephedrine to make meth.

    Parents dont know how much tylenol to give their kids and even the packaging underdoses. Do you think it was any better with these medications? It was all a crap shoot. Too little tylenol, too much dextro, maybe the right amount of pseudoephedrine… That’s more confusing.

    “CardioNP” bashing the committee chair seems well …hmm (if you cant say something nice dont say anyting at all).
    All it takes is intellect to weight the evidence especially when it all seems one sided. BTW Where are your publications listed?

    just my $0.02. *over*

  7. As the parent of a child who so much as gets a runny nose and it goes straight to his chest…. YES, THEY DO WORK in kids. Sometimes, they meant the difference between my child being up all night long with a cough and being able to rest for at least a few hours.

    What I am concerned about is the fact that if people can’t get the kids’ version, they will use the adult versions of the cough medicines with possibly disastrous results.

  8. Michelle, there are no “kids” version of any of these medicines. Most were never tested in children, just extrapolated down. Dextrometophan is the same in delsym as it is in any other medication, just a liquid with flavoring added.

    Has your child ever been diagnosed with “a chest cold,” “touch of pneumonia” or “bronchitis,” after having a runny nose for a few days?

  9. #1 I’m the one who bashed the committee chair because she is straying outside of her specialty. What is the basis for her assertion that children’s medications don’t work when she probably hasn’t touched a child since her residency? She’d get mocked up and down the courtroom if she tried to testify at a trial about this stuff. But since she’s in the ivory tower no one even questions her qualifications.
    #2 Who gets to choose whether to take a medication based on its efficacy? If Tylenol doesn’t reduce fever by “X” amount in some subset of kids should the FDA take it off the market, too? How about all the medications for AIDS? They don’t always work and there are lots of side effects. Lets just get rid of them all.
    #3 Are we now going to start removing medications from the market because of side effects? Hey, teenagers can take nutmeg and get high. Lets take that off the market, too. http://www.erowid.org/experiences/exp.php?ID=7905. Oops. Narcotics can make me sleepy. Lets get rid of them. Ooooh. And all that Ritalin makes my kid hyper. Gone. Once you start down this slippery slope, where do you stop?
    My kids respond well to OTC medications and I think I have enough intelligence to see the difference before and after administration. If the FDA is going into “protect the stupid Americans from themselves” mode jump in with both feet and lets see how inane the proposition gets.

  10. While I was taking a shower, I almost forgot. Lots of people die from water intoxication. Maybe the FDA should regulate water, also. Ration it so no one gets swelling of the brain. And I saw someone get stabbed to death by a screwdriver once. You should probably need a prescription to get one of those now. See how silly the argument becomes?

  11. #1 Can’t speak for her basis, but my guess is the large body of PEER REVIEWED literature that asserts that OTC cough medication have no clinical signiicant decrease in symptoms when studied in large population. I think in a court room, she has two legs to stand on. Plus the AAP also endorsed this position

    #2 Who gets to choose? Someone should. Should we go back to snake oils for rheumatism? Remember, this panel is NOT the FDA, they’re an advisory committee to the FDA though the FDA follows this groups’ recs. There are lots of medications with side effects like chemo meds, AIDS, etc but the side are worth the risk. They all have to prove that they have some efficacy in large populations of people. N of 1 is not scientific proof.

    You say lets get rid of them all in jest but we might almost be better off if the FDA did. How many medicines commonly prescribed for children have ever been tested in children not counting OTC’s? The percent is dismal (albuterol/morphine are two examples that come quickly to mind). Necessity and common sense dictates our use of these medicines until something better studied appears.

    #3 If the side effects are a health risk why not? Children are a vulnerable population. Who looks out for them?
    Narcotics and Ritalin are prescription medications taken (hopefully) under supervision of a doctor.

    Should we put cigarettes back on the shelves and allow anyone to buy them because not everyone gets cancer? Lower the drinking age to 15 because 25 years olds dont drive? Stop giving vaccines because kids can have fever afterwards?

    OTC cough and cold meds are not the same.
    Your kids may respond well, that’s good if they get symptomatic relief.

    Does it make their actual colds go anyway any faster? Does it prevent it “from going to their chest”? Does it prevent that pneumonia? Does it prevent that “sinusitis”?
    Probably not but that is the assumption that parents are going on.

    Heard this before?
    “My baby had a cold over the winter and it “turned into” RSV. He hasn’t been sick all summer because as soon as he gets a cold i give him dimetapp to prevent it from going to his chest.”

    The FDA is trying to do a job (how well, I don’t know) and as a physician I think you should look at the body of literature that is available and come to scientific conclusion that is supportable with info available at the time.

    Slippery slope or a step to protect children? You talk about patient asking for antibiotics. This is a similar scenario. Asking for meds that could be dangerous for mild-moderate symptoms that will improve in a few days.
    I guess you could give them antibiotics for that 5-10% of URI’s that are bacterial because then you know those 5-10% would get better.

    BTW had a patient with an allergic reaction to Delsym last night. Swelling of the lips and urticaria.

  12. In one sentence, give me the rational basis for your assertion that kids shouldn’t take OTC cold medications. Think about it carefully, because after you post it, I will try to show you how arbitrary the decision is using your hypothesis as a starting point. My intent is not to attack you personally, but rather to attack whatever notion you propose.

  13. NY PEM DOC:

    “Michelle, there are no “kids” version of any of these medicines. Most were never tested in children, just extrapolated down. Dextrometophan is the same in delsym as it is in any other medication, just a liquid with flavoring added.

    Has your child ever been diagnosed with “a chest cold,” “touch of pneumonia” or “bronchitis,” after having a runny nose for a few days?”

    This is a can of worms I do not want to open because it would turn into a long vent and hijack this post.

    Yes…. he was diagnosed with reactive airways disease. This was after basically arguing with a doctor and spending many MANY sleepless nights with him coughing until he vomited, watching him turn blue in the face, unable to catch his breath, sitting up, holding him upright in a steamy bathroom to ease his breathing. He had numerous bouts of viral pneumonia and two episodes of bacterial pneumonia.

    The argument was me telling the ped he was wheezing and the doctor telling me that “kids that age can’t have asthma.” The change came when I got angry one day at the 4th time my son coughed until he vomited and was unable to breathe, so I took him as a walk-in to the clinic and said, “Do something NOW. This has to stop.” He saw a different pediatrician who took a chest x-ray and saw air trapping. His pulse oximetry was 90%. He was given an albuterol treatment along with Pulmicort, and after that we got both a home nebulizer and a couple of MDIs.

    The thing is, now, for us, he is older…. he can have a little cough syrup to suppress that urge and be okay. If this doesn’t keep the coughing at bay, we start albuterol to keep his airways open. However, if we don’t suppress the cough, then we have problems, as it becomes a self-perpetuating thing…. he coughs, which irritates his throat/airways, and he coughs more.

    Interestingly, my son also has cold urticaria. We’ve seen an allergist (of course, cold urticaria can’t be diagnosed on any type of allergy testing, other than with an ice cube applied to his skin); however, he has an elevated C4.

    My point about people giving kids adult medicines is just that: There are people who can’t afford to go in and see a doctor every time their child gets a cough, and if they do, they may be met with sarcasm and disdain. They will resort to whatever measures they *think* they can do to help their child rest and improve. Is it better to have these things in manageable doses, or do we want people trying to play junior pharmacist to figure out how much to give to their kids?

    The average person doesn’t have a clue about overdosing their child. All they know is their kid can’t sleep because he’s hacking up a lung, they’ve got to sleep and be to work in 5 hours, and there has to be something in here in the medicine cabinet to help them sleep. Here, let’s try some NyQuil…

  14. Who cares if these meds make the “cold” go away any quicker? That’s not what they are for. Rhinorrhea and nasal congestion are annoying enough to justify the use of OTC antihistamine/decongestant combinations in both adults and children, and the fact is that multiple studies suggest that rhinorrhea and nasal obstruction are indeed improved by the use of these medications. Even in children and infants.

  15. My mistake. There aren’t many studies in infants, but those that exist don’t show benefit other than sedation. This is a great overview”.

  16. 12: One sentence:
    These medications have never been proven to be more effective than placebo in relieving symptoms of the common cold.

    Here are a few examples of what I base my opinion on.
    PEDIATRICS Vol. 108 No. 3 September 2001, p. e52
    PEDIATRICS Vol. 114 No. 1 July 2004, pp. e85-e90
    Cochrane Database Syst Rev. 2003;(3):CD001267

    13: I am sorry your son had to go through what he did and it took another pediatrician to diagnose your child with something that was more than a cold. In retrospect it seems like kid always had RAD/Asthma from your story. Unfortunately your case does demonstrate some of what is wrong with these medicines. They only sedate kids and do little for the real symptoms. They make you think you are doing something good for your child when you could be masking the real culprit. And yes kids usually aren’t formally diagnosed with asthma until 2 or 3 years of age but RAD is commonly diagnosed in infancy and is the same illness. You probably know more about asthma now that your child is hopefully being dx/tx as such and probably have looked at the pediatric asthma guidelines. In the recommended therapies, there are no mentions of any of the commonly used cough/cold medications discussed.
    I would also say that most asthma docs would prefer you start your rescues inhalers with the first signs of cough rather than wait for the cough medicines to stop the cough. Cough is a sign of URI/Cold but can also be the first sign of an asthma attack.


    I think your last point is what I am trying to get at, “*think* they can do to help” and “The average person doesn’t have a clue about overdosing their child.” I would add they may not have a clue to dose correctly either. Is this safe?

    Our acceptance of these medications in general have been based on the fact that the have worked on adults so they should work on kids. In fact, most medications we use were never initially studied in children.
    Albuterol as an example… safety and efficacy never really studied in kids until xopenex came on the market.
    It wasn’t until the late 1990’s that drug companies were required to test *new* drugs on children before they could be marketed. Most older drugs are “grandfathered” so they don’t need to be studied either. Ask your pediatrician the next time a drug is prescribed if it was testes in children.

    Having these meds out there in pediatric friendly forms (i.e. liquids/meltaways) doesn’t make then any safer.

    Your story reminds me of something that still happens though less frequently now that there are safer (and studied in children) medications. Prior to zofran (a previously costly anti nausea/vomiting medication), kids were often treated with adult medications for vomiting and nausea with medicines like tigan/compazine etc. These medicines are great in adults, you stopped puking and you went to sleep. Unfortunately when used in young kids, they did stop vomiting for a while, but were so sedated that they got more dehydrated from not drinking. Worse case scenarios, they had brain tumors and their vomiting was a another symptom that was being masked (seen in my still relatively new practice.)

    My point after all this, these medications were never proven to be of benefit, there are real risks of injury, they are heavily marketed to parents (and physicians) and they are targeted at a population that is vulnerable and needs to be protected.

    I am up at 5:31 California time because my 11 month old has a cold and his cough has woken him up several times tonight. Is he in distress, no but he is definitely uncomfortable. I do wish there was something I could do to make him feel better faster but I am doing what I *know/think* is best for him and what I tell my patients to do, look for signs of respiratory distress, encourage fluids, and manually “suck the snot out.” That’s the best modern medicine has for a cold in children.

  17. 15: Scalpel
    They also were not shown to make the “runny nose” or “coughing” any less.
    The overview you presented was last revised in 1997, ten years now. Most of the original article cited were even older. The AAP has changed or made stronger recommendations regarding the use of these medications, mostly against the common use of them.

    This is a problem, it takes time to change the notion that these meds help to any real extent.

    Whitecoat: I don’t take it personally and I hope I didn’t offend or seem to attack anyone.

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