FDA to Review Children's Cold Remedies

It seems that children’s cold medicines that have been in use for decades may not have gotten rigorous FDA review when they were first introduced. Subsequently, the popularity of the various brands may have made the FDA reluctant to review their safety and effectiveness. From the NYT:

The agency has for decades promised to review systematically the safety of all old drugs, but for a variety of reasons like budgetary constraints, time and popularity of a particular drug has not done so.

We, like the reader who sent this story in, find it troubling that “popularity” is a factor in deciding whether or not to review the safety of a drug. The New York Times doesn’t explain in detail what is meant by this quote, but we’re hard pressed to think of any explanations that would make us say, “Wow, that’s really awesome.”

In addition to safety, the FDA is also going to review the drugs for effectiveness, as new studies show some cold remedies are no more effective than a placebo.

“There is widespread consensus that there is no good evidence for the effectiveness of several of the compounds used in cold medicines,” said Dr. Ian M. Paul, an assistant professor of pediatrics at Penn State College of Medicine who has studied the medicines. Last year, the American College of Chest Physicians recommended that parents avoid using cough and cold medicines in children, especially young ones.

Despite these growing worries, sales of the drugs are booming. Most major pharmacies carry a dozen or more brands.

This is an article you’ll want to read if you have children, particularly children under the age of 2, as it has also has some good information on recommended dosing and ways to avoid dangerous overdose. —MEGHANN MARCO

U.S. Reviewing Safety of Children’s Cough Drugs [NYT] (Thanks, Jason!)


Edit Your Comment

  1. snowferret says:

    I would think they would look to test popular drugs first seeing as they affect more people.

  2. mopar_man says:

    Hmm….the FDA will pass a nonprescription diet drug but they’ll skip over children’s medicine? Fantastic!

  3. royal72 says:

    “In addition to safety, the FDA is also going to review the drugs for effectiveness, as new studies show some cold remedies are no more effective than a placebo.”

    [sarcasm] well, as long as the cold meds get kids high and knock em out, who cares if they actually alleviate symptoms… [sarcasm/]

    fda, go fuck yourself.

  4. wezelboy says:

    Some of the OTC drugs can be VERY dangerous. I would never ever give my child dextromathorpan for instance.

  5. vanilla-fro says:

    how does a placebo effect a child under two who wouldn’t know what is supposed to happen anyway? I thought it only worked on people who knew what the drug was supposed to do.

    Anyway, children’s medicine should be one of the most tested as they tend to get sick more often, have weaker bodies, are still developing, and can’t decide what to take on there own after doing any research.

  6. bluegus32 says:

    I was in the pharmacy the other day looking for an effective cough syrup for my young son. The very nice pharmacist told me that none of them work. In fact, most adult cough medicines don’t work either.

    But then again, kids are very easy to manipulate with the placebo effect. So I got an old empty bottle of childrens’ medicine that I had at home, filled it with syrup and water, and told my son that it was cough medicine. And it worked.

    Moral of the story — avoid giving kids (or yourself) medicine unless it came from a doctor. Even though, be weary. Medicine is more about profit than it is about helping people.

  7. mopar_man says:

    That’s very interesting.

  8. erockO says:

    they should just go back to old-school (early 20th cenury) elixirs that were just alcohol and/or opium. I miss the days when they made OTC meds that could kill a kid!

  9. faust1200 says:


    Whoah I just made that up. Who’s up for a Robitussin-bong?

  10. kimsama says:

    We are…Penn State ^_^

    When I was a student there I had a professor who told us that cough medicines were more harmful than beneficial. And just to never ever buy cough suppressant.

    And bluegus32, you are so right — a little honey on a spoon works just as well as store-bought crap if you’re creative in how you present it to children (I was suckered into this for a decade because I loved Mary Poppins. Anything in a spoon worked like a charm).

  11. Jesse in Japan says:

    Sounds like they’ve finally figured out the secret ingredient in Flaming Moe’s.

  12. Metschick says:


    yup. My mom makes all these home made elixirs with honey. Honey and salt. honey and garlic. It all tastes wonderfully horrible, but I’d rather take that than any OTC cough medicine.

  13. QuirkyRachel says:

    @bluegus32: Excellent use of psychology!
    My parents rarely gave me medicine unless really necessary.

  14. Tonguetied says:

    I always thought the reports of the ineffectiveness of cough medicines were pretty bogus. The report basically said that “these medicines don’t cure your cough”. Well duh! They supress the cough reflex for a time. It’s a temporary patch to let you sleep or to give your throat a break. I know it ain’t perfect but it’s generally better than nothing.