FDA Considers Banning OTC Cough Medicines For All Children Under 6

Pediatricians are asking the FDA to recall all OTC cough medicines for children under six years old, and the FDA is holding a public hearing on the subject today. One reason this has only recently become an issue is that when the FDA originally set rules for OTC cough medicines, they were based only on studies for adults, not kids, writes the Associated Press. Although there’s a low risk of unintentional overdose—the AP says about 7,000 children are admitted to ERs each year—the other issue is that there’s very little evidence that they’re effective.

“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.”

“FDA urged to recall cold medicines for youngsters” [Associated Press]
(Photo: Getty Images)


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  1. DeltaTee says:

    If all the cough medicines for children under six are pulled off the shelf, then, effective or not, parents will just give their kids the adult version. How is this an effective policy?

    • davere says:

      @DeltaTee: ding ding ding!

      • ELC says:

        @davere: So again, we are supposed to allow some regulation in the hopes that the adults won’t be idiots and put their kids in peril. If the stuff doesn’t work (adult cough/cold medicine does nothing for me), then why give it to them? If they choose to, and injure their kids, then I guess they can go to jail for it.

    • @DeltaTee: It’s not, because they won’t pull the stuff for young kids 6 and up… so parents will just use that instead, which is pretty much the same thing. And barring that, you’re right: they’ll crank up the adult stuff and the number of kids in emergency rooms will jump 35%.

    • Parting says:

      @DeltaTee: Why not give kids honey? It soothes the throat, and unless you’re allergic, not dangerous. (I’m talking about real honey, not chines processed shit that sell 99cents a bottle with ”honey” label.)

      • alexawesome says:

        @Victo: Because honey can be deadly for kids under a year old. Young children don’t have immune systems equipped for dealing with bacteria in honey, which is why it’s perfectly safe for older children and adults to eat.

      • floraposte says:

        @Victo: Honey can actually be dangerous to kids under a year old (they’re susceptible to the botulinus spores found in it for the first year or so). Not that I think they’re the prime recipients of cough medicine, but it’s worth noting.

    • mwshook says:

      @DeltaTee: It shifts the litigation risk off of the pharma companies and doctors.

      @Victo: honey is great for cough, but not to be used under 12 months.

  2. Gopher bond says:

    As long as I can still get me cases of the Grape Dimetapp, I don’t care.

  3. "I Like Potatoes" says:

    When I was a kid, parents all gave their kids baby aspirin. Then they found out that was bad so people stopped using it. They didn’t pull baby aspirin off the shelves, though. People were informed of the dangers and they could make their own informed decision. Why should this be any different?

  4. quail says:

    If the kid’s cough is bad enough to hang on after a sleep inducing dose of OTC cough medicine then it’s time to get a prescription. Why do parent’s insist on over dosing?

    And I’ll agree with the above comment. If they do away with OTC for kids some parents will become even more crazy in what they give their kids. (Ever deal with a coughing, cranky kid late one night? You’ll do anything to help him and get back to sleep.) They’ll use adult OTC cough medicine or even whiskey.

    • zentex says:

      @quail: or even whiskey.

      Always use brandy on kids. It’s got a fruity kick, and it’s sweet. Save the expensive whiskey for yourself.

    • pbwingman says:

      @quail: I’ve never given booze to my daughter, but I have thinned out/reduced the dose of the older kid stuff. Then you sigh in relief when they sleep for even a few hours.

  5. Ayanami says:

    They’re not supposed to be “effective” for cough and cold, they’re pain suppressors, nothing more. If they were “effective” the cough or cold would go away faster. which it does not. Seems to me like the FDA is just trying to make itself look over good over something that shouldn’t be an issue

    • fredgar says:

      @Ayanami: Sorry, but you’re wrong – children’s cough and cold OTC meds are clearly marketed for symptomatic relief of the symptoms (cough, congestion) of colds. Although some contain an analgesic (such as Tylenol), it is put in there for treatment of fever, not pain, since there isn’t much of a pain component to the common cold generally. There are lots of medications that provide ‘symptomatic’ relief without shortening the duration of the underlying illness. And finally, the regulatory function of the FDA as defined by federal law is to insure that OTC and presciption meds are both safe and efficacious. Unfortunately, all of these pediatric cold medicines (like all medicines in fact) can present the risk of toxicity, and IN FACT, we have known for more than 30 years that none of the marketed children’s cold medicines work any better than placebo or chicken soup in either providing symptomatic relief or shortening the duration of illness.

  6. krom says:

    the other issue is that there’s very little evidence that they’re effective

    I sort of think this is probably true for most adult cold medicine, too.

    • Gopher bond says:

      @krom: The old NyQuil, before the meth-heads and overzeaouls legislation ruind the formula, was fantastically effective. Well, maybe not at treating the symptoms but after one or two shots, you sure as hell didn’t care.

      • LostAngeles says:

        @testsicles: Exactly! I’ve gone back to Robitussin now. Until the media finds out about Robi-trippin’, we should be ok.

      • TheStonepedo says:

        @testsicles: I think you can still buy the old formulas of things (at least it’s the case with Robitussin) but they’re marked differently and occasionally not available in all stores. I actually prefer medicines where I have a choice of several “recipes”; the little differences make you think about just what the hell you’re putting in your body.

      • The Porkchop Express says:

        @testsicles: I think you can get that behind the counter.

    • homerjay says:

      @krom: Why did Vicks take the pseudophedrine out of NyQuil all together? Why didn’t they just have two versions like Sudafed where the good stuff is behind the counter and the crappy stuff that they make now is on the shelf?

      I miss NyQuil……

      • dorastandpipe says:

        I can’t even buy something with DIPHENHYDRAMINE in it at good old Target without them harassing me for my birth date/ ID in order to purchase it. The new version of NyQuil has it and I was told they ask for ID or at least a birth date because “teenagers buy it to get drunk.” OK, so now I just refuse to buy products that you unnecessarily ID for at your business.

      • BytheSea says:

        @homerjay: Ugh, I know. Dayquil has some other decongestant in it, but Nyquil? Only has a fucking antihistamine. I’m so angry I bought it without reading the label, thinking they’d both have effective ingredients.

        Robitussin changed the formula, too, so now I’m just screwed when I get a bad cold and I’m snotting everywhere. Not like I need to go to work or anything.

  7. flaxen_vixen says:

    A shot of Irish Whiskey, tablespoon of honey, squeeze of lemon juice, slightly warmed is the only cough medicine any kid needs. Alcohol is a natural cough suppressant and will make a little one sleepy, honey soothes the throat and the lemon is that extra kick of vit C.

    • Gopher bond says:

      @flaxen_vixen: You’re seriously advocating giving kids alcohol?!? Do you not know the drinking age is 21?!?! Are you a terrorist? Won’t someone think of the children?

      • flaxen_vixen says:

        @testsicles: “one will make you larger, and the other will make you small, but the ones that mother gives you don’t do anything at all….”

        There already is a ton of alcohol in kid’s cough syrup.

    • @flaxen_vixen: Strangely, my daughter’s pediatrician gave us a very similar recipe. Off the record of course.

    • LostAngeles says:

      @flaxen_vixen: Vitamin C doesn’t do much unless you take it in, “megadoses.” [www.newscientist.com] But regular dosing apparently does shorten it.

      Liquids, on the other hand, are great for you, so don’t skip the OJ. Or swap it for Gatorade or what have you. You want to stay hydrated when you’re ill.

      But I’m totally backing you on the booze. A shot will kill the pain at the very least.

    • catastrophegirl chooses not to fly says:

      @flaxen_vixen: in my family it was always equal parts honey, ginger brandy and lemon juice. served warm, a teaspoon at a time. the honey soothes the irritation in the throat and the ginger and alcohol clear some airways and the acidity of the lemon cuts the mucus. that’s what the pediatrician said anyway. stills works for me even now….
      including the part where it knocks me out and i actually get to fall asleep when i am sick.

      if a parent gave this to a kid today, i am guessing they could get hauled away to jail and lose custody.

    • no.no.notorious says:

      @flaxen_vixen: my mom (german/irish/croatian) said that her parents would give her a taste of whiskey when she had fevers/tooth aches as a child. would knock her right out.

      if it ain’t broke, don’t fix it!

  8. LostAngeles says:

    So as an aside, I can’t help but wonder if this is also in part from the parents who dose their kids to make them shut up….

  9. BeeBoo says:

    An expectorant without an antitussive can be helpful for children and adults.

    Personally, I just take decaff tea with lemon and honey. It helps loosen phlegm and open the sinuses and soothes the throat. The shot of whiskey might not be a bad idea, either.

  10. savvy999 says:

    I find that putting a pillow over my ears is the best way to deal with my kids when they’re sick with a hacking cough. No use both of us being up all night.

    Keep ’em hydrated and warm, they’ll eventually get better.

  11. bilge says:

    Once out of desperation, I had some whisky when I couldn’t find any cough syrup. Worked like a charm. Now whenever I have a cough, it’s Suntory time.

  12. There’s a Chinese medicine in most Asian markets. I don’t know what it’s called because the label is in Chinese, but its got honey and elm bark, which my singing coach always made me suck. Its gloopy and dark red/black, but its fairly effective and completely innocuous in terms of poisoning the chillins.

  13. ElizabethD says:

    Who is old enough to remember being given Paregoric (over the counter liquid) for a “tummy ache”? I was as young as 3 and remember getting little dropper-fulls of the licorice-tasting stuff. Of course it was pure narcotic. And it worked like a charm. (Donnatal Rx is closest today.) Man, we kids had fun with substance abuse back then!

  14. magic8ball says:

    See, I’m questioning the FDA’s definition of “effective” here. Are OTC cough and cold medicines effective at curing a cough or cold? Obviously not. That’s not why we give them to our kids, nor why we take them as adults. We take them because they alleviate our symptoms – and they are somewhat effective at that. If their definition of “effective” is “cures your illness,” then they should ban adult cough and cold medicines as well.

    OK, please don’t tell them I said that, OTC decongestants are my friend when I’m sick.

    • whatdoyoucare says:

      @magic8ball: I think the reason the FDA is recalling the cough medicines is because the meds aren’t effective at alleviating the symptoms (and obviously not at curing the cold or cough). If the meds aren’t effective at alleviating the symptoms why drug the kids? I believe this is only directed at cough medicines and not at decongestants.

    • floraposte says:

      @magic8ball: I don’t think they’re suggesting “effective” is the same as “curative”–I think they just mean the medicine is supposed to do what it says it does, whether it be alleviating symptoms or shortening the duration of illness, for its target population.

      Like you, I’m not giving up my symptom suppressors any time soon.

  15. Razorgirl says:

    Does anyone else notice that it is “pediatricians” who are making this request? No matter the merit or lack thereof to their assertions that OTC cough medicines are ineffective for children under 6 years old, the group making the suggestion only stands to profit from removing the product from sale.

    I don’t want to suggest that our pediatricians are not concerned with the well being of our children, but with the cold and flu season approaching in many areas of the country, this poses a major problem. Either parents will indeed resort to giving their children remedies that may not be wholly appropriate, or they will have to pay to take the child to the doctor in order to obtain a prescription. With so many people struggling financially, I would be willing to bet many people will be finding their own methods of addressing the issue at home, rather than spending money they don’t have to take their child to the doctor for a cough.

  16. pecan 3.14159265 says:

    My mom used to give me warm coke and lemon when I had a cough or sore throat. On one road trip, a friend of mine got really sick off chicken at Subway (I didn’t eat Subway for the next three years) and it was about 2 a.m. when his symptoms hit, and we were kind of in the middle of nowhere…in a town, but stores weren’t that convenient. There wasn’t really anything we could do about it, but we had some coke and lemon and it helped him feel better until we got some OTC stuff.

  17. Murph1908 says:

    We, adults and humans, over-medicate enough the way it is.

    When you are sick, you feel like crap for a reason. That’s your body saying, “Hey, dipshit. Lay down. Sleep. Let me mobilize the white cells and fight this battle.”

    Taking anything for the sole purpose of alleviating symptoms is doing you and your body a disservice.

    I’ve lived by this practice for 18 adult years and guess what…I don’t get sick often. And when I do, I take the day off, drink fluids and sleep, and I am fine in a day.

    • Murph1908 says:

      Adults and humans???
      Adults and children.

    • Tonguetied says:

      @Murph1908: And if you’re so sick that you can’t get any sleep because your body is racked by coughs and you’re feverish?

      Taking medicine to reduce the symptoms so that you’re actually able to rest is wise. Taking medicine to reduce the symptoms so that you can go out and play with the other kids is not wise.

      • Murph1908 says:


        Yes, better to medicate and rest than medicate and stay active.

        But I still believe you are tricking your body into not fighting the infection/illness as hard.

  18. LionelEHutz says:

    Sounds to me like the Pediatricians and Pharmacies are just looking for more business (you get tagged with a copay on both ends if you needed to get a prescription, assuming that you have insurance).

  19. BytheSea says:

    How are they not effective? They lower the kid’s fever, stop them coughing, break up the congestion, and let them and the parents sleep. Are they basing that claim on the fact that there isn’ta cure for the common cold, only a way to suppress the symptoms?

    • floraposte says:

      @BytheSea: I think they’re basing the claim on the fact that there’s no hard evidence showing that they do lower fever, break up congestion, and produce sleep any greater than placebo in kids. Medication often works very differently in kids and adults (and in men and women, which is a sticking point with some treatments too). They’re also not tested for safety in kids.

      I don’t see how this is a bid for more business on the part of doctors and pharmacies, though–they’re nowhere saying that the kid should be brought to the doctor or given a prescription instead, and there wouldn’t be many additional options if the kid did come in.

  20. 718brooklyn says:

    Personally, I am a strong believer of herbal medicine. With that said, I would never give any of my children OTC drugs that only suppress the pain. The best way to combat these symptoms are to make sure your child has a well balanced diet to start out with and that they are taking enough Vitamin C during the day. For sore throats with children, herbal tea is the best way to go.

  21. Tonguetied says:

    I think this will end up working out the same way the pajamas ban did a few years back. Loose fitting pajamas were deemed to be unacceptable so the only styles that were permitted to be sold were form fitting pjs tat many children and parents didn’t like. So parents started just puting their kids in loose shorts and oversized tee shirts and not buy pajamas at all.

    Or similar to the time they began requiring that infants have a separate plane seat. As a result instead of flying people started driving and since driving is more dangerous than flying more babies started being killed.

    Parents are going to be looking for something to relieve the symptoms that their children are having and so they will get out the older children versions or even worse the adult versions and dose their kids with them.

    In the long run this will be extremely counterproductive.

  22. jstonemo says:

    Most OTC cold medications for children already state that it is for kids over 6. If you look at the dosing chart on the bottle, it says to ask your doctor for dosing children under 6. There are very few cold meds for toddlers/babies as it is right now.

    My 3 year old has a hacking cough at night right now and we only give her children’s Robitussin (half of the 6-12 year dosage) at bed time. During the day, she is on her own. Your body will not heal as quickly when you can’t get any sleep because you are hacking up lung chunks all night long.

    This site has been a great help when trying to figure out dosing for kids under 6. [www.askdrsears.com]