FDA Says No Cough Syrup For Toddlers Without Doctor Approval

The FDA is warning parents not to give cough syrup to children under 2 without doctor approval after becoming concerned about the number of children where were overdosing on OTC syrup. The FDA will also convene a panel of experts to evaluate the use of cold medicines in children.
“Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age,” the agency said.

There have been hundreds of overdoses and a “handful” of deaths from OTC medicines, according to the Washington Post. Current labels already warn parents not to give cough syrup to children under 2, but they don’t seem to be very effective.

FDA Warns Against Giving Cough Medicine to Toddlers [Washington Post]


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  1. Mom2Talavera says:

    When my daughter was little I have her Boiron Chestal Homeopathic honey Cough Syrup. Its safer and has a pleasant taste.

    /The FDA sucks

  2. Cowboys_fan says:

    How much cough syrup does it take to kill a kid? I mean if parents are giving a whole jar/day, that would be alot different than a few teaspoons. I find it curious they don’t mention that. What do they expect us to give them?

  3. QuirkyRachel says:

    What?! But I’m an American and I trust the FDA implicitly! I want drugs! And my kids want them, too!

  4. cabedrgn says:

    @Cowboys_fan: By talking to a couple of pharmacists at work there apparently is more likely hood of allergic reaction or their bodies not being able to handle even a ‘normal’ child dose of some of these medicines.

    Take into account weight. An average 2yr old weighs what; 20lbs? An average 4yr old weighs around 40lbs.

    So the 1/2 teaspoon is almost double the dosage for a 2yr old than a four year old. After figuring in other factors (such a liver, metabolism and such) a 1/2 teaspoon to a 2yr old could be the equivalent of giving a 4yr old 2 to 3 teaspoons meaning possible overdose.

    Its smart to check with a doctor before giving your child medicine when the bottle states “If under age X, check with your doctor.”

  5. madktdisease says:

    apparently, everyone’s been listening to that flight attendant.

  6. @madktdisease: Beat me to it.

  7. revmatty says:

    As you so rightly note, all kids medications advise you to consult your pediatrician for children under two. Our three year old got medications at various times, and our current babies will most likely get meds as needed before they are two, but we are always in close contact with both our pediatrician and the Children’s Hospital here anytime the kids are sick at all.

    Most of the time the meds simply don’t do any good (e.g. giving them enough to affect the symptoms would be dangerous) so it’s better to just give them plenty of TLC and help them to feel better.

    @Mom2Talavera: You do realize that ‘homeopathic’ means “we’re charging you $3/oz for water”, right?

  8. Nemesis_Enforcer says:

    @cabedrgn: Hmm 20 lbs for a 2 year old? My 10 month old weighs 22lbs, and before anyone flames me he isn’t fat he is in the 85th percentile for height. He is about 32 inches tall. So or doctor says he is in perfect balance for height/weight.

    Our pediatrician advised us to half whatever the dose was for a 2 year old, and we have only given him meds the doctor advised us were ok.

  9. cabedrgn says:

    @Nemesis_Enforcer: Yea, on further reading, avg weight for a 15mo old is around 20lbs. 2yr old is around 27/28lbs according to Kids Health.

    @REVMATTY: I’m also close to a children’s hospital (Arnold Palmer) which has come in handy a couple of times.

  10. jrdnjstn78 says:

    I have lots of parents come in wanting to give their,under age 1, child all kinds of medicines. no wonder why some of these children are overdosing on medicine. Some parents are just clueless when it comes to medicines for babies.

  11. paco says:

    I stopped giving my five-year old daughter Dimetapp (or anything with dextromethorphan) last year when I realized that it not only did very little for symptoms, but also radically changed her behavior. It was just after that that I first learned about the groups pressuring the FDA to step in on this. What really gets me is that these medicines have never been tested for kids because the powers-that-be decided they were too popular.

  12. tlynch says:

    No more cough syrup? How am I supposed to get the kids to sleep now? I hope Benadryl is still OK. ;)

  13. allthatsevil says:

    @Mom2Talavera: Honey can give infants botulism. Way to go, you!

  14. allthatsevil says:

    @Mom2Talavera: Honey can cause botulism in infants. Way to go, you!

  15. allthatsevil says:

    @allthatsevil: I just love when comments don’t show up after almost 15 minutes, then magically appear when you try to re-post them, making you look like an idiot.

  16. kaikhor says:

    I think the only thing I have ever given my daughter (who is 21 months) without first checking with the Dr is infant tylenol and that is for teething only. Otherwise, call first!

    Oh, and my daughter is 34 inches tall and 31 lbs, which everyone says is just fine and she’s not yet 2

  17. homerjay says:

    I find the only two medications that I will give my child without first checking with the doctor are Lister’s Carbonic Ungent and a Balsam Specific.

  18. homerjay says:

    Oh, and for diaper rash, the best has always been Smeckler’s Powder.

  19. formergr says:

    @allthatsevil: Um, she never specified how old her daughter was when she gave her the honey cough syrup, just that she was “little”.

    Babies 12 months and older can safely eat honey.

  20. CumaeanSibyl says:

    @revmatty: Hey, at least you can’t OD on homeopathic remedies.

  21. allthatsevil says:

    @formergr: True, she didn’t specify age. But considering we’re talking about kids under 2, there’s a good chance she was talking about giving it to her daughter when she was under a year. I could be wrong – stranger things have happened.

  22. allthatsevil says:

    @CumaeanSibyl: Technically yeah, you can OD on pretty much anything: Water, vitamins, air…Maybe not likely, but definitely possible.

  23. revmatty says:

    @paco: To be fair, the primary reason there hasn’t been testing is it’s real tough to get parents of infants to agree to let them be part of a clinical trial.

  24. lizzybee says:

    @allthatsevil: Botulism isn’t a disease– it’s a bacterial infection. Only bacteria-contaminated products can cause botulism. Honey isn’t inherently contaminated with Clostridium botulinum– the same honey that would give an infant botulism would do the same thing to an adult, depending on the levels of botulin in the honey.

  25. allthatsevil says:

    @lizzybee: I don’t remember saying anything about botulism being a disease. And you’re wrong – honey does cause botulism in infants (as someone mentioned, under the age of 12 months) but not in adults. Why don’t you Google it before trying to correct me?

    Or better yet, call your pediatrician.

  26. erica.blog says:

    @tlynch: the sad thing is that a lot of parents apparently don’t think the whole Nyquil/Benadryl for getting them to sleep through the night is a joke ;-)

  27. @paco: It seems like they almost always just test things on healthy adult males and assume the rest of the population will react the same way.

  28. synergy says:

    I was going to say that parents are probably trying to knock out their kids instead of taking care of them, but everyone beat me to it. It’s what happens when I get 5 days behind on the Consumerist. :D