FDA sets kids' dosing for liquid meds
May 6th, 2011
11:47 AM ET

FDA sets kids' dosing for liquid meds

Figuring out how much liquid medication to give your baby or toddler should be a little easier, if manufacturers follow the Food and Drug Administration's final recommendations for liquid over-the-counter drugs, which were released this week. The FDA is asking manufacturers to provide clearly and consistently marked delivery devices (syringes, cups, droppers or spoons), which will provide accurate doses of the liquid medication.

These guidelines grew out of concerns over confusing and/or mismatched instructions between labels and dispensing devices can lead to children getting too much or to little medication.

"Accidental medication overdose in young children is an increasingly common, but preventable public health problem," says Dr. Karen Weiss, in a statement. Weiss is the director of the "Safe Use Initiative" in the FDA's Center for Drug Evaluation and Research.

If an OTC liquid drug product does not provide a dispensing device, you have to use what you have, which could be a spoon from your kitchen drawer or a syringe from another drug for example.  The problem is that these alternative measuring devices can easily lead someone to get the wrong dosage.

Many products do come with dosing devices, but if you look at the measuring units in instructions printed on bottles or boxes, you might find they don't match those on the cups or droppers etc.  In other cases the measure markings on cup or syringe exceed the actual possible doses you can take – which just makes things confusing.  And if the instructions on the box call for teaspoon and the cup lists milliliters,  the confusion can lead to someone getting the wrong amount of the drug.  These types of scenarios are particularly dangerous when you're dispensing medication to the youngest patients.

These "final" recommendations closely resemble those draft recommendations first put out by the FDA in 2009.  The Consumer Health Products Association, an organization that represents companies that make OTC liquid products, issued guidelines similar to those of the FDA that same year. Companies are not legally bound to adhere FDA recommendations, which is why they are only guidelines and not requirements.

According to an FDA spokesperson, only minor changes and clarifications of the initial recommendations were needed based on public comments to the 2009 guidance. One clarification that resulted, was that the "guidance are intended only for orally ingested over the counter (OTC) liquid drug products."

A study published in the Journal of the American Medical Association last November confirmed the need for changes in product labeling.  After looking at 200 OTC liquid drug products, it found about a quarter didn't come with a measuring device and while 75% did have provide a spoon or a syringe or other dosage delivery device, almost all (98.6%) had at least one mismatch between dosing markings on the measuring device and the written dosing directions.

At that time the CHPA said: " It is our goal that all OTC medicines will fully follow the [CHPA] guidelines by the end of 2011."

Dr. Darren A. DeWalt, who is an associate professor of Medicine at University of North Carolina School of Medicine and wrote an accompanying editorial to the 2010 JAMA study, hopes that the FDA's publication of these final recommendations with lead "some companies will interpret it as another reminder that they need to get this done." He believes more needs to be done to avoid overdosing but says "the FDA is a little bit stuck because of a lack of research to tell us exactly how to make the [best] labels."
Time will tell if manufacturers will make the necessary adjustments. In the meantime, the FDA provides "10 tips to prevent an accidental overdose."

soundoff (12 Responses)
  1. dom625

    I don't recall my sons *ever* being happy about medicine. How about we show a picture of a mom straddling a kicking, screaming toddler and having to forcefully deliver the medicine?

    May 6, 2011 at 13:29 | Report abuse | Reply
    • turtlesoup

      You really make me wish these comments had a "like" button. The only baby that smiles like that for a medicine dropper is one who's never actually had to take any medicine. Getting medication down my toddler is an epic battle every time.

      May 6, 2011 at 19:36 | Report abuse |
  2. WellnessDrive

    Any amount of medicine for an infant scares me – unless there is an absolute need.

    One area that I prefer for stomach problems is using Aloe Juice. Everyone knows the healing power of Aloe Vera. Of-course, always check with your Dr on any product. Our kids love the taste of the Ultimate Aloe Juice from WellnessDrive.com.

    May 6, 2011 at 13:34 | Report abuse | Reply
    • Lasciel

      Extreme caution here!!!!! Recent research showed high doses of aloe ingested in rats led to tumors. (read in April issue of New Scientist)

      May 6, 2011 at 16:46 | Report abuse |
    • nina786

      yup..i totally agree.....


      May 7, 2011 at 11:14 | Report abuse |
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