14 Children's Cold Meds Withdrawn From the Market

Johnson & Johnson today recalled several infant cough and cold medicines, citing “rare instances of misuse leading to overdose, particularly in infants under two years of age.”

The FDA recently issued a public heath advisory warning parents of the risk of overdose from OTC cough and cold medicines when administered to children under 2, and has been taking a much closer look at cold and cough medicines marketed towards small children. Safety experts advising the FDA on the issue have been recommending that the drugs be pulled from the market.

According to a safety report commissioned by the FDA, at least 54 children died after taking decongestants, and 69 died after taking antihistamines from 1969 to 2006. The report also suggested that that those numbers were probably significantly understated because deaths from overdose are “reported voluntarily and fitfully.”

The following products are being recalled by Johnson & Johnson:

  • 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

On Oct. 18, the FDA’s Nonprescription Drugs Advisory Committee will meet to discuss the issue.

McNeil Consumer Healthcare Is Voluntarily Withdrawing Infants’ Cough And Cold Products (Press Release) [Johnson & Johnson] (Thanks, M.!)

Comments

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  1. gmark2000 says:

    As Mary Poppins sang “A spoonful of sugar helps the medicine go down”…

    That’s the trouble of making medicines appealing to children with grape, bubblegum and whatever flavouring. Having sweet, sugary solutions will make the kids want them like candy.

    That was the danger of Flintstones vitamins. Kids started eating them as candy.

  2. KingPsyz says:

    As a new dad, I would rather pay my co-pay rate for a perscribed medicine than what is sold over the counter.

    $10 for a doctor perscribed medicine is a lot better than $9 for some random OTC medicine which may or may not have an adverse effect on my baby, seeing as I am not a doctor.

  3. Trai_Dep says:

    I hate year-and-a-half drug addicts. Why can’t they just be winos, like kids were when I was their age?

  4. SkyeBlue says:

    When my grandaughter was about 3 years old her mother had to rush her to the hospital because she was having hallucinations of snakes. The Dr. said it was caused by her being given a children’s pain reliever AND an OTC cold medecine at the same time. People think they are relatively harmless since they are sold OTC but that isn’t the case.

  5. Jaysyn was banned for: http://consumerist.com/5032912/the-subprime-meltdown-will-be-nothing-compared-to-the-prime-meltdown#c7042646 says:

    I bet they all have dextromethorphan in them.

  6. kelmeister says:

    I was carded last night trying to by generic NyQuil at the supermarket. It didn’t even have pseudoephedrine in it…heck, it doesn’t contain a decongestant at all.

    This doesn’t have anything to do with kids and cold medicines, but it was a really random WTF moment, and as I am doped up on cold medicine I felt obliged to share.

  7. protest says:

    @KingPsyz:
    do you have to be a doctor to follow the directions on the box?

    i don’t understand why this recall is even happening, the numbers figure to about 3 kids per year. from what i read, all of these children died from overdose caused by misuse, meaning they were given more than the directed amount, or were given more than one medicine at once.
    maybe J&J want to see if they could lower the recommended dose so if parents can’t read directions they will be less likely to accidentally kill their kid?

  8. RottNDude says:

    So this recall is due to the fact that a few people couldn’t be bothered to read the directions on the side of the box? Interfering with such stupidity should be a crime. Thin the herd, folks!

  9. Womblebug says:

    I think the recall is due in part to deaths from misuse, and in part due to the fact that these medicines don’t do diddly for kids this age. My pediatrician told me that in clinical studies the cold medicine ingredients (decongestant, cough suppressant, etc) had no more effect than placebos on kids under five or so. Risk of death + no real benefit = time to go.

    Better to use humidifiers, saline sprays, etc.

  10. MYarms says:

    I’d be willing to bet that this recall has less to do with infants and more to do with trashy people making meth from the cold medicines.

  11. TedOnion says:

    @RottNDude: This recall is due to the fact that there is a question of the safety and effectiveness of these drugs. They are also targeted at children under two which should not be given drugs if they are not under the supervision of a doctor.

  12. Elvisisdead says:

    @KingPsyz: I’ve been a dad for about a year now, and there are some medicines that a doc won’t prescribe. Like OTC decongestants. However, ANYTHING you administer to a kid under 2 needs to be cleared through a doc first. Don’t even think about giving a kid under 9 months ibuprophine because their little livers can’t handle it, and it can cause liver failure.

    I’ve given our daughter the PediaCare stuff, but only when the doc says so, and only in the dose he says.

    @GMARK: My kid hates the stuff. I tasted it, and it tasted bad. Like bitter cherries.

    The problem here is that jerkholes can’t or won’t read the dosing instructions and give their kid the recommended doseage. You have to know how old the kid is and what they weigh. If you take your kid to the doc for checkups, you know the weight. If not, you better get a flipping scale and find out before giving your kid a weight-based doseage of medicine.

    Most of the droppers on these medicines have two lines on them (measuring a single .4 oz dose and a .8 dose for a larger weight/age). The trick is that the larger doses are and AND condition. I don’t recall exactly, but something like 9 months AND 15 pounds for a .8 dose. Either/or doesn’t work, but that’s not clearly stated. If you do it wrong, it can kill your child.
    The problem is that people don’t consider how an amount of a substance that’s harmless to an adult can really injure a child.

  13. indiie says:

    A local woman was just in court for giving her baby an overdose of cold medicine, killing him. Then of course she tossed the baby in a dumpster…. I believe she was on meth. yikes.

  14. j03m0mma says:

    How about the scientific studies that have been published in medical journals that state that children’s cold and cough medicines do ZERO to help a childs cough. A glass of water does more. Check story [seattlepi.nwsource.com]

  15. FightOnTrojans says:

    I have a bad feeling that in a year or two, we are going to see an increase in overdoses amongst children under two as parents resort to giving their children the regular strength medicine. I can just imagine the thought process:
    1. The children’s medicine was just a watered down version of the adult’s medicine.
    2. It should be ok to give them this, just in a smaller dose.
    3. Darn, doesn’t seem to be working, let me give the baby more.
    4. Back to Step 1.
    5. Eventually, call poison control and 911.

    I’m not saying that these items shouldn’t be pulled from the shelves, but I am concerned about the long-term ramifications. If people were dumb enough to OD their kids on the infant-strength medicine, you better expect them to continue with the adult-strength.

  16. jacknval says:

    @FIGHTONTROJANS – you can count on it!

    I used these one my 3 kids and they seem to work. Of course I follow the directions. They also pulled the triaminic cough patches I used to buy for my kids last year because 6 kids ate them and 1 had a siezure. Pretty soon we will not be able to buy any OTC products due to people’s stupidy and love of a big lawsuit!

  17. paco says:

    Ummm… The problem is not necessarily reading or not reading the instructions. The problem is that the instructions are guesswork based on adult bodyweights with the same medicines. There is _no_ telling how a child will react to these medicines–and there has never been any formal testing of the medicines on children. That is the problem.

    Blame the FDA and the corporations, not the parents.

  18. Namilia says:

    I recall a woman that would give her unruly children benadryl to make them fall asleep whenever they got too rowdy, rather than actually take the time and effort to parent them. She wasn’t even a particularly busy person with multiple jobs, etc..she had one job at fast food. Seeing such bad parenting left me completely disgusted..I wonder if abusing childrens’ medicines as a form of discipline is entailed in this also.
    “I don’t feel like dealing with Junior right now.”
    *gives junior a larger than necessary dose of medicine*
    *junior goes to drug-induced sleep*

    Like has been said, some parents seem to assume that since it is OTC it is perfectly safe, which of course is not the case.

  19. Namilia says:

    @paco: I’m not typically a victim blamer, but in this case, because of my previous comment and a feeling she isn’t the only one who abuses childrens’ drugs in this fashion, I’d have to only half agree with you. You make a good point about the FDA and dosages being based on body weight, and perhaps some of those deaths resulted as a repercussion of lack of formal studies, etc. But I think that in at least some of the cases, it is also bad parenting or parents not reading the dosage and assuming they fill up the little cup that comes on top or somesuch.

  20. karimagon says:

    Look at the products being recalled: Mostly infant-branded medicine. That’s because the infant-strength stuff is concentrated and is actually way stronger than the children’s strength stuff. Thus, it’s was easy to overdose a baby with it, if you don’t read the directions because you think you understand how the dosages work.

  21. taka2k7 says:

    lovely… I just bought some infant medicine yesterday…

    Directions say to call doctor first for kids under 2. I’d be curious as to what percent of the kids who were overdosed don’t have a family doctor. Maybe the directions should say, “1. Reform Health Care 2. Get a doctor 3. Call doctor for doseage amount 4. Send the doctor your next paycheck”

  22. nancypants says:

    A lot of the problem with the misuse comes from people dosing according to age and not weight.

    The efficacy and safety of the drugs themselves isn’t so much the issue, although dextromethorphan is really considered to be useless in children, it’s that they’re not being dosed properly.

    The problem is mainly that with kids that young, their weights change often and quickly, and parents have to estimate. Add to the fact that they may not be using the proper measuring devices and the medications are concentrated, leaving less room for error, and you’ve got a recipe for a dead kid.

  23. nancypants says:

    @taka2k7: Did you try talking to the pharmacist for a dose?

    If it’s really not safe, I don’t see them telling you a dosage for it. I know all the folks I work with never would, but they will give you a dosage according to weight, which is much safer than just estimating.

    Besides, “consult a doctor” doesn’t mean “schedule an appointment.” Call the office, call a walk-in clinic, tell them what’s going on and see if they’d at least recommend it. The worst they can do is say, “Sorry, you’ll need to come in.”

    Sorry for the double post.

  24. Red_Eye says:

    Yes its true some parents kill their kids with this stuff. Some though do the responsible thing and ask their doctors what they can and cant do. What they can and cant give. The problem in some of these cases I am sure is not so much the meds it the lack of having a doctor to communicate with over the child’s care.

    In my case my wife leaves all the medicine decisions for over the counter minor symptomatic stuff between me and the dr. So I have had to educate myself in pharmaceuticals a bit. Youd be shocked just how many of these meds have the EXACT same ingredients and you wind up overdosing your kid if you dont learn to read the labels. A gret example that comes to mind is mixing perscriptions and non perscription drugs. For example for bad allergies my kid gets proscribed Bromaxafed, what is it? That can be a little difficult to find, turns out its brompheniramine/dextromethorphan/pseudoephedrine. Dextromethorphan is a common cough suppressant and pseudoephedrine is a common decongestant.

    Now since big pharma hides that information by reformulating the 3 drugs into on amalgam so they can patent it and make more profit who suffers? That right your kid. Because without that knowledge you can on top of their already medicated state ADD the same medication again. Now big pharma aint trying to hide the contents and your pharmacist can usually tell you whats in a medication. But its up to the consumer to ask and educate themselves but in the end if you dont want a dead kid…..

  25. Hambriq says:

    This has been in the cards for weeks now.

    Here’s the thing: OTC cough medicines should not be given to children under 2. You can say it’s parental stupidity for not reading the box when it says Usage Instructions for Children Under 2: Ask A Doctor. But when the products are marketed as “Infants Cold Drops“, that pretty much implies you can use it on infants.

    But let me reiterate the main point. OTC COUGH MEDICINES SHOULD NOT BE GIVEN TO CHILDREN UNDER 2. NOT NOW, NOT EVER, NOT 6 MONTHS AGO.

  26. Hambriq says:

    @Red_Eye: “For example for bad allergies my kid gets proscribed Bromaxafed, what is it? That can be a little difficult to find,

    Ugh. Someone needs to give your doctor a wake up call. Prescriptions like Bromaxafed, Pseudovent, and various other combinations of OTC cough, cold and allergy medications are the biggest ripoff in the pharmaceutical industry. They are proprietary blends in specific amounts, so they can’t be generically substituted, and they cost between 50 to 100 dollars for a 30 days supply, whereas the equivalent amount of OTC medicine would cost between 10 and 20 dollars.

    They are almost exclusively manufactured by tiny companies who are hoping to cash in on people’s ignorance of what actually goes into prescription medicines. And they do. What’s even worse is stuff like Adoxa and Solodyn, which are $300-$400/month versions of generic Doxycycline and Minocycline, respectively, both of which cost approximately $15/month.

    When people talk about “Big Pharma”, this is the kind of shit they are referring to.

  27. paco says:

    @Namilia: Right. I agree with you, except for one thing. If the medicines were not so heavily marketed creating the consumer’s presumption of safety, the likelihood of your example might be lowered… and leave plenty of other ways for those people to be bad parents.

  28. KingPsyz says:

    @protest:

    As has been mentioned elsewhere in the comments, this isn’t just about the “overdose” issue, which I think is fairly non-existant with normally intelligent people. Although when it comes to an infant, like say my 2 week old who was just circumcised and was perscribed pain medication if he couldn’t rest, the difference between correct doseage and overdosage is fairly microscopic.

    The real reason for the recall in my mind anyway, is that some of these drugs can have a large impact on an infant and in reality, medical care for children under 2 should be handled by a medical professional.

    If you have kids you should do whatever it takes to make sure at least they have some sort of insurrance.

  29. whiteswan3711 says:

    I am from another country where doctors and even pharmacists actually care about the patients and not their wallets. Most doctors there will not take advantage of their patients’s ignorance when it comes to medicine, unfortunately, in the U.S. this is not the case. A lot of times the doctor doesn’t even know all the facts before prescribing the medicine the pharmaceutical company paid him to prescribe. Every time I went to a REAL doctor he or she would first suggest dietary means through which I would gain better health or relief from whatever ailment I had. They would tell me what to eat, more importantly, what not to eat as well as, prescribe certain herbs and therapeutic procedures. Only as a last resort would they ever prescribe something that has as many side effects as an average American prescription. For some strange reason Americans think that their government protects them from anything and everything, including their own ignorance, this is not true. Because the U. S. gives major corporations way too much power, they take advantage of consumers. To avoid danger you must always look into the side- effects of the medicine you are taking yourself or are giving your kids.Often, just by looking at the small print on the back of an add in a magazine can be enough to turn you off. For example, a while ago there were Zoloft adds all over the place, if you look on the back of the add it lists an enourmous amount of dangerous side effects among which is,”…may cause suicidal thoughts…” Why would any parent in their right mind give kids medicine that is even remotely rumored to cause death when there is a multitude of natural products out there that have no side effects unless you are taking other dangerous drugs, prescribed or over-the-counter, or are allergic to them. All you have to do is read, be cautious and do your own research.