Patterico's Pontifications


FDA Re-evaluates Children’s Cold Medicines

Filed under: Government — DRJ @ 7:19 pm

[Guest post by DRJ]

Following last week’s restriction on the use of cold medicines in children under 2, an FDA panel issued a nonbinding recommendation against their use in children under 6 years of age:

The medicines long used by parents to treat their children’s coughs and colds don’t work and shouldn’t be used in those younger than 6, federal health advisers recommended Friday. The over-the-counter medicines should be studied further, even after decades in which children have received billions of doses a year, the outside experts told the Food and Drug Administration. The FDA isn’t required to follow the advice of its panels of outside experts but does so most of the time.

“The data that we have now is they don’t seem to work,” said Sean Hennessy, a University of Pennsylvania epidemiologist, one of the FDA experts gathered to examine the medicines sold to treat common cold symptoms. The recommendation applies to medicines containing one or more of the following ingredients: decongestants, antihistamines and antitussives. It doesn’t apply to expectorants, though many of the medicines also contain that ingredient.”

Why do I have the feeling these recommendations may be based on the same science that led to Britain’s legal intoxication standards?


28 Responses to “FDA Re-evaluates Children’s Cold Medicines”

  1. DRJ, the cold medicines are virtually useless for adults (at best, they relieve symptoms, and at worse, they are glorified placebos) and for children, dangerous.

    I agree completely with the FDA here and have for years. If you have children of the affected age, I’d urge you to follow their advice.

    Christoph (92b8f7)

  2. I took plenty of codeine for my coughs as a kid and I turned out just fine.

    Dude (7787b4)

  3. No, it was based partly on the fact that an infant died in central IL after being given some children’s cold meds…

    Scott Jacobs (a1de9d)

  4. Christoph,

    The author of this 2004 review published in the Journal of Infectious Diseases in Children suggests a different view – that there may not be enough data to say one way or the other:

    Overall, published evidence from well-done, controlled trials of CCM in the pediatric population is limited. This is especially true for young children, in that few published studies have evaluated CCM. Smith reviewed clinical trials of OTC CCM published between 1950 and 1991 to determine efficacy in children, adolescents and adults. Well-defined criteria were used to assess trials for scientific validity. Only two studies of children younger than 5 years of age were found that met inclusion criteria. Neither study provided evidence of benefit. Two studies evaluated CCM in older children (5 to 11 years of age), with some evidence of benefit of nasal decongestant and antitussive ingredients.
    Despite the availability of numerous CCM products, published evidence from well-done clinical trials documenting their efficacy is sparse. Published evidence for the efficacy of CCM in young children does not exist. Some evidence for CCM (decongestants, antihistamines) efficacy in adolescents and adults does exist.

    Note that he does find evidence to support the use of antihistamines in young children for its sedative effects. Studies also show some of these products do provide symptomatic relief in adolescents through adults.

    [NOTE: This comment was initially sent to the spam filter. I pulled it from moderation to add the link and complete quote. — DRJ]

    DRJ (67ced6)

  5. DRJ, the point is they have little if any benefit, certainly inconclusive, and they are potentially harmful. I am of the view that no responsible adult in light of this position by the FDA would offer their children under six these formulations. If you have a different view, that’s fine; I’ve shared mine.

    Christoph (92b8f7)

  6. Anyway, sorry, I was too abrupt and too absolute. I got these medicines as a kid… but medically and scientifically, I have long doubted their uselessness. Symptomatic relief at best with the possibility of harm.

    Obviously, anti-histamines are different. I’m referring to the decongestants and such. I personally wouldn’t recommend these medicines to anyone and would argue against their use. My girlfriend and I have discussed it and when we get married and have kids have decided not to use these barring further proof of their safety and effectiveness.

    The kids will live.

    Christoph (92b8f7)

  7. Warnings are fine but I’m not inclined to give any more power to pediatricians than they already have. This strikes me as a first step to greater regulation, not the final step.

    DRJ (67ced6)

  8. How the hell does this give more power to pediatricians and what do you have against them anyway? I’m saying dopey parents shouldn’t give their kids probably worthless drugs.

    Christoph (92b8f7)

  9. Because pediatricians will tell parents not to give these products to their children when they might have authorized it before. I’m all for improving our knowledge and making better decisions based on that knowledge, but show me the studies that say this is based on better knowledge.

    DRJ (67ced6)

  10. … symptomatic relief at best …

    This seems a strange thing to say. Symptomatic relief is the whole point, and I don’t think anyone has ever claimed otherwise.

    LTEC (858b88)

  11. Because pediatricians will tell parents not to give these products to their children when they might have authorized it before.

    So how does this increase the power level of pediatricians?

    Christoph (92b8f7)

  12. Let me give you an example: My secretary has a 12-month-old daughter who has occasional allergy symptoms. The pediatrician did not authorize the parents to use Benadryl for symptomatic relief until their daughter was 10 months old. Occasional Benadryl made a big difference for her and, consequently, for her family. Now, however, the pediatrician has told the family not to use Benadryl because of the FDA’s recommendation and the family has complied.

    In other words, the family will do what the pediatrician tells them – which gives the pediatrician a lot of power over their lives – and the pediatrician will recommend whatever the FDA tells him to do. This is how things are supposed to work but the whole thing falls apart if the FDA’s recommendations are not based on valid scientific data.

    DRJ (67ced6)

  13. LTEC, touché. That’s all the drugs could have accomplished in a best case scenario.


    The panel’s advice dovetails with a petition filed by pediatricians that argued the over-the-counter medicines shouldn’t be given to children younger than 6, an age group they called the most vulnerable to potential ill effects. The American Academy of Pediatrics and other groups back the petition.

    … I don’t know. I’m not really sure I support you in your war against the treat of pediatricians’ ever increasing power. I think they might know a whole lot more about the danger of drugs and which ones work than you do.

    I personally have more faith in a pediatrician’s medical knowledge than the average American parent. God bless the parents when it comes to teach what values and morals their children should have, but not what drugs.

    Christoph (92b8f7)

  14. *treat = threat

    Christoph (92b8f7)

  15. Like lawyers, physicians provide expert opinions and they aren’t supposed to make decisions for us. Unfortunately, very few people these days understand the difference.

    DRJ (67ced6)

  16. DRJ, your comment 12 is a good example and you could be right… but this argues for your secretary’s pediatrician’s weakness, not strength. It argues for the FDA’s strength.

    Christoph (92b8f7)

  17. I doubt a pediatrician could buck the FDA’s recommendations and stay in the good graces of his malpractice insurance carrier and participating HMOs/PPOs.

    DRJ (67ced6)

  18. Therefore, you prove my semantic point that this doesn’t increase pediatricians’ power.

    Christoph (92b8f7)

  19. If you mean the real problem may be the FDA, I agree, but parents get their advice from pediatricians and they are the mechanism that implements FDA guidelines. These guidelines may weaken the pediatrician vs. the FDA, but the parents’ ability to choose treatment options are weakened compared to the pediatrician’s.

    DRJ (67ced6)

  20. Leaving aside for a moment the fact that I agree with the FDA’s new position wholeheartedly and was at least a decade in advance of them, “If you mean the real problem may be the FDA…”

    What or who else do you think it is?

    Christoph (92b8f7)

  21. I’m not sure where this is coming from. I assume (and I mean this sincerely) that it is based on a heartfelt desire to protect kids from dangerous products, but that doesn’t mean the FDA is the source of the concern. It could also be the CDC or the AAP, especially in light of reports like this.

    Much of this seems to relate to reported infant deaths from pseudoephedrine, which in the linked case was at 9-14 times the recommended levels. One significant problem seems to be the lack of appropriate dosing instructions and parents who overdose their children. I have no problem with limits on pseudoephedrine and products that include it, or with educating the public about the dangers of stimulants. I’m not so sure about the blanket prohibition on everything else.

    DRJ (67ced6)

  22. Thanks for the elaboration.

    Also, I am a huge opponent of pseudoephedrine and related drugs. In your country, you sell concentrated capsules of it at the checkout stands of almost every friggin’ gas station and convenience store. Yet it can cause interruption in heart rhythms and I know people who have felt its effects — and as adults. Here is one more reason why I agree with the FDA.

    Decongestants in general are stimulants.

    Christoph (92b8f7)

  23. I’ll have to read up on the potential side effects, but I cannot just shrug off the fact that they have worked for my kids.

    Drugs do work differently on different people. I’m not so dumb I’d keep giving my kids something that doesn’t work. When you have a child who has so much congestion that they are waking up in the night to throw up all over themselves, you and their bed, you might think that a little relief is a very good thing.

    I almost never take cold meds myself, because I don’t like the way they me feel, but my kids react differently.

    MamaAJ (788539)

  24. #10 is on the money. I already understand that there is no cure for the common cold. Don’t we all know that? I want to relieve my kid’s symptomatic suffering.

    How does one determine effectiveness on infants and toddlers? After giving my kid a dose of Children’s Tylenol, he always feels better and calms down. But then, he may have done so anyway with the passage of time. These tests and trials are worthless.

    Christoph, best of luck to you and your future children. When they get sick (and they will), you will need a will of iron not to open that bottle of medicine.

    Viktor (6c107f)

  25. It seems the FDA is just another bunch of buricrats making wacky suggestions

    krazy kagu (171210)

  26. i am a physician and suffer frequent attacks of asthma and allergic symptoms. i use these medications only for their symptomatic effects nothing else. a child under 6 years no way. look at the dangerous massive use of ritalin and other stimulants for so-called attention deficit disorders. atd is a symptom of parental atd and not the child. retarded emotional growth and all kinds of side effects result from the stupidity and ignorance of medical practitioners and parents who suffer from child racism syndrome. children should see no evil, hear no evil and say no evil is the way of neanderthal idiots who do not comprehend that beloved of the lord are the children who are magnificent wonderful creatures full of evil and good. dr adam rosenblatt

    adam rosenblatt dr (8db014)

  27. I agree with you Doc, but some safer altenatives would be nice! As far as overdosing don`t you think it`s time to ajust the print size on the
    dosage directions and bolder markings on the droppers! As a Nanny i believe this would help alot for safer dosing. Nanny Sandi

    Sandi Houle (c4b55b)

  28. Wait, someone killed their kid by giving the poor tyke TEN TIMES the recommended amount for kids twice their age, plus aspirin, while two of the three kids were *already* on prescription meds…so they’re dangerous?

    Jeeze. Let’s outlaw knives. If you’re dumb enough to slice off your kid’s hand, they could bleed to death. Outlaw antifreeze– if you ignore the warnings and drink it, you’ll be poisoned. Etc, etc, etc.

    The parents involved should be charged with negligent homicide. There aren’t even OTC *doses* for kids under two.

    Foxfier (290c52)

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