FDA considers ban of some medicines for children

What will I do now when you're sick?
What will I do now when you're sick?
If you are the parent of a young child like I am, you are probably bombarded with conflicted information, much like I am.

Don’t give toddlers whole milk! There is too much fat in whole milk for their diets! You must give toddlers whole milk! Their brains need the fat to develop!

And, if you are the parent of a small child, you live though, and often experience first hand, every illness they come across – including what appears to be an honest interest in the world record for number of colds in a 6 month period.

Now information comes out of the Food and Drug Administration (FDA) on over-the-counter (OTC) multisymptom cough and cold medicines for children under 6 that makes life more confusing. Back in August they issued a safety advisory and last Friday safety experts working for the FDA urged the agency to ban all these multisymptom medicines and to standardize the cups, droppers and syringes included with products for children to reduce confusion and the resulting possibility of overdose.

The recommendation comes from a 356-page report in which the FDA’s safety experts reported that there is little evidence that multisymptom cough and cold medicines are effective in young kids, and that they may in fact be dangerous. According the report, over the past 37 years at least 54 children died after taking decongestants, and 69 died after taking antihistamines. A study by the Centers for Disease Control found that more than 1,500 children under the age of 2 had suffered serious health problems after being treated with common cough and cold medicines between 2004 and 2005.

Not surprisingly, the drug companies have an industry trade group called the Consumer Healthcare Products Association, and they issued their own report (only 156 pages) and they recommended adding mandatory warning labels indicating that the drugs not be used in children under 2, but not that they be banned. Currently when you look at the back of these medicines, they tell you to “consult your doctor” for administering to children under two.

The next step in this process is a meeting of outside experts on October 18 & 19 to examine the safety issues and provide recommendations to the FDA.

It is an interesting dilemma for our household as we head into cold season (and as I see all the runny noses this morning at daycare). My doctor recommends using them, as other remedies (saline drops and suction to clear out the nose – not fun and propping up their head while they sleep) don’t seem to help much. And from my perspective, the cold medicinesdo seem to help. What will we do the next time our 18-month old gets sick when my experience is that I can give her something that will make her feel better but that there is a small, but dangerous, chance that in doing so I am putter her at risk? I think I’ll be forced to make a decision about this very soon.

Your Comments, Thoughts, Questions, Ideas

Liza's picture
Liza says:

The Canadian equivalent of the FDA has also recommended that over-the-counter cold medications not be packaged for kids under 6. (As of right now, the FDA says these medicines shouldn't be used by kids under 2, and many manufacturers are changing the labeling to require that parents of children under 4 check with a doctor before dosing. And the FDA is considering new recommendations for children ages 2-11.)

So what's a parent to do?
If you've got a coughing child over 1 year old, try honey. It won't do anything for a drippy or stuffy nose, though. In those cases, saline washes, humidifiers, lots of liquids--that's your arsenal.

posted on Mon, 12/22/2008 - 3:22pm
Liza's picture
Liza says:

You might think that a product like Vick's VapoRub is safe for those under-sixers, since they don't ingest it so there's no possibility of overdose. But a new study says not so fast.

Turns out the popular cold remedy can cause severe respiratory distress in kids under two. When applied directly under the nose, VapoRub can cause a child's airway to swell and fill with mucous, making it tough to breathe.

The message: don't put VapoRub under anyone's nose, child or no, and don't use the product at all on children younger than 2.

posted on Tue, 01/13/2009 - 12:06pm
Anonymous's picture
Anonymous says:

I never knew that you needed to give babies whole milk and how important it is for their diets!

posted on Mon, 06/28/2010 - 1:37pm

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