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Bye, Bye Dimetapp- No more Kids Colds Medicines?

Posted Aug 26 2008 11:36pm

Just as we head into cough and cold season, major manufacturers have removed popular over-the-counter medications for kids from the market. These are of course are exactly the ones we don’t think about until our little ones are coughing and sneezing at 3:00 in the morning.

Not all kids cold medicines were withdrawn, fever reducers, such as Children’s Tylenol and ibuprofen are still available but, some of our favorites were…you know, Children’s Dimetapp, Pediacare and Children’s Robitussin. I wrote about this issue and what to do instead here.

Now there is an update out, as reported in this NY Times article F.D.A. Panel Urges Ban on Medicine for Child Colds. Though the original withdrawal was voluntary…in other words, major manufacturers pulled the products before the FDA forced them to do so, an FDA committee has recommended that medicines marketed to children under 6, containing selected ingredients be withdrawn; so an order from the FDA to do so could be forthcoming.




"The data that we have now is they don't seem to work," said Sean Hennessy, a University of Pennsylvania epidemiologist, one of the FDA experts gathered to examine the medicines sold to treat common cold symptoms. The recommendation applies to medicines containing one or more of the following ingredients: decongestants, antihistamines and antitussives. It doesn't apply to expectorants, though many of the medicines also contain that ingredient.

So, let me see…it seems that children’s medicines containing these drugs, that is those to relieve stuffy (decongestants) or runny (antihistamines) nose and cough (antitussives) will all be removed from the market. Why? the reason given seems to be, “they don’t work”…that however is not really the complete story. Note the wording in the above statement:

“The data that we have now is they don't seem to work”

In other words…there have been no studies done on children using these drugs. The pharmaceutical industry has tested these products on adults and then cut the dosage recommendation on their children’s version. This is of course of no surprise to many women who have found, to their shock, that many, many drugs are only tested on adult males. This leaves us in a bit of a quandary. These drugs may work in children…but no one has proven it yet. On the other hand…they may not and we are needlessly medicating our children. The panal’s recommendation indicates they are taking no chances.


Whatever the outcome in the marketplace, the panel’s advice for parents was clear. They should not use over-the-counter cold medicines in young children.


What worries me though is what one panel member said:

Amy J. Celento-Stamateris, a patient’s representative on the panel from Nutley, N. J., said she was worried that a ban would lead parents to give their children products intended for adults, increasing the risks of overdoses.

The American Academy of Pediatrics has a list of things to do instead of giving these medicines. Most of which you will recognize from your grandmother’s advice book. But, I really worry about what many of us will do when “nothing seems to work”.

This will take a change in mind set – which if you think about it logically isn’t that hard. The biggest concerns when a child has a cold are fever and dehydration. Cold cloths and children’s Tylenol or ibuprofen, which are both still available, can help get a fever down. Dehydration can staved off with lots of water. The other symptoms as doctors are prone to tell you, usually aren’t life threatening…just uncomfortable – coughs and stuffy or runny nose. And it is drugs that fight these 3 symptoms that the FDA recommends being removed from the market.

Ever practical, Dr. Sears has some excellent advice for not-quite-crunchy parents concerned about what to do this flu season. You can find it here. So, I guess we’ll just follow Doctor’s orders again this year!

By the way, did you know there are over 39 different ingredients used in OTC medicines for children? Yikes!

Related posts: No More Infant Cough and Cold Medicines, now what?

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