Very young children simply should not take some commonly used cold and cough medicines, federal health officials say in recommending that the “consult your physician” advice to parents on the labels be dropped.

The preliminary recommendation, from Food and Drug Administration safety officials, would apply to decongestant use in children under 2, and antihistamines in those younger than 6, according to agency documents.

“The basic question is, why should a product be so relentlessly marketed when it’s not safe or effective?” said Dr. Joshua Sharfstein, Baltimore health commissioner. “It does not make sense, in the absence of information, to say ‘consult a physician,’ because they do not have superhuman powers. They cannot make a product safe or effective.”

The Baltimore petition came on the heels of a Centers for Disease Control and Prevention report that found more than 1,500 toddlers and babies wound up in emergency rooms over a two-year period because of the drugs.

There are 800 over-the-counter cough and cold remedies on the list to be re-evaluated. Great job you’ve been doing – FDA.



  1. MikeN says:

    Cool, they should let more drugs onto the market. Health care is too expensive as it is. Now if they would loosen up their medical licensing.

  2. Mister Mustard says:

    There’s no money to fund the FDA. We’ve got a MISSION to ACCOMPLISH, to the tune of $200,000,000,000.00/year. You could pay the salary of an awful lot of new hires at the FDA for two hundred billion bucks a year.

    But that would be something BENEFICIAL to America. Can’t be having that.

  3. Hope42 says:

    My son is now 36 years old. When he was around 8 years old my pediatrician at the time prescribed Dimetapp whenever he had a cold. I told the doctor that I had read an article in the newspaper saying that Dimetapp had been shown in independent studies to have no affect whatsoever. He didn’t believe me and continued to prescribe the swill for the next 10 years for all of my children whenever they had a cold.

    I see the present articles also say Dimetapp and the other children’s cough and cold medicines do nothing. What a scam!
    Meanwhile whoever makes these so called medicines make millions of dollars.

  4. Mr. Fusion says:

    The Baltimore petition came on the heels of a Centers for Disease Control and Prevention report that found more than 1,500 toddlers and babies wound up in emergency rooms over a two-year period because of the drugs.

    Fair enough. How many toddlers and babies ended up with emergency visits because of a cold?

    Of these 1,500 visits, how many involved side effects of the drugs or that the children were not responding to the cold medicine?

    Is there an effective cold remedy for young children that is safe?

  5. Ben Waymark says:

    Mr. Fusion: Is there an effective cold remedy for young children that is safe?

    I think the question can stop as ‘is there an effective cold remedy’ and the simply answer is no. They are all snake oil. There are decongestant that work, but not cough syrup. What they should do is put labels on all the cough syrups saying “Warning: do not feed to children” and “Warning: this product is snake oil. It does nothing.”

  6. Mister Mustard says:

    >>There are decongestant that work, but not cough syrup.

    To paraphrase Bill Clinton, it depends on what you mean by “work”. There most certainly are cough suppressants that work. Dextromethorphan, for example. They treat the symptoms, rather than the underlying condition, but if you’re coughing up lung meat, they’re a good port in the storm.

    I guess it would be expecting too much to put “do not administer to children under 6 (or 2)” on the label, and assuming parents would comply.


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