FDA rejects ban on children’s cold and cough medicines: CHPA to the rescue?

by James Hubbard, M.D., M.P.H.

The FDA met to look at evidence, take comments and decide whether there should be a ban on children’s cough and cold medicine under the age of 6.  They acknowledged the evidence from pediatricians that it was not effective at that age and sent thousands of kids to the ER each year.  Then they punted.  No ban or recall.

A spokesperson for the FDA acknowledged there was no evidence that the meds worked under 6  (apparently the meds were “grandfathered” by the FDA many years ago with no tests on children), but was afraid that parents would use stronger adult meds on children if there was a ban.  The American Academy of Pediatrics does not recommend the meds under 6 and an independent group advised the FDA to ban them last year.

Now in steps the Consumer Healthcare Products Association (CHPA) to save the day (sort of).

CHPA is made up of the manufacturers of the aforementioned meds.  In a statement, they volunteer to label “do not use” for children under 4 on all of their pediatric cold and cough meds. A list of the manufacturers and meds involved are at their otcsafety.org pdf site.  CHPA says the drugs are safe.  They are labeling them because children under 4 tend to get into the tasty medicine and overdose.  Also many parents don’t dose correctly. (Both are true and documented facts.)

But no one is putting a gun to your head.  Don’t use them in children under 6.  Instead try JHMFD‘s tips.

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5 Responses to “FDA rejects ban on children’s cold and cough medicines: CHPA to the rescue?”

  1. Dr. J Says:

    It’s unfortunate that drugs have become so ubiquitous in our society! Maybe Nancy Reagen was right :-)

  2. James Hubbard Says:

    True Dr. J. “just say no”.

  3. cathy Says:

    I’m so conflicted on this one. It bothers me when they say that the cold medicines don’t work on children because that is not my experience. They work WONDERS for my older child – always have – but my youngest might as well drink water for all of the good it does her. They clearly do work for some children, though those children may be in the minority.

    Also, I’m a stickler for dosages, so if the medicine is safe at the recommended dosage, well, I have a problem with it no longer being available for our use.

    Still, I don’t like the waffling. Either take them off of the shelf and make them prescription only for children or else declare them safe at the recommended dosages.

  4. James Hubbard Says:

    Good point, Cathy.

    If you are going to use them, don’t mess with the dosage amount and time between doses. Also keep them out of reach of children always.

  5. lhubbard Says:

    I just got some interesting thoughts from people on Twitter ( https://twitter.com/FamilyDoctorMag ).

    One woman wonders, if they don’t work on kids under 6, why can we buy them? “It’s so confusing,” she says.

    A doctor declares, “FDA blew it!” He or she (not sure because of the Twitter name) says the FDA taking a stand “would help with the false expectations.”

    But another doctor, a primary care physician, argues, “Sedation is the best argument for OTC meds. Kid feels lousy and you make them sleep.” He’s not had experience with kids being harmed, he says.

    Those are just some of the comments. Seems like an interesting topic, and people have thought-provoking arguments on each side.

    Leigh Ann Hubbard
    Managing Editor
    James Hubbard’s My Family Doctor

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