Cold drug debate could take years to shake out

While the outcome is seldom certain with FDA advisory panels, often one strong personality dominates the decision making. In this case the key player was not a physician, but Amy Celento-Statateris, a “parent representative” from Nutley, N.J.

Celento-Statateris became an activist in children’s health causes when her child was diagnosed with a rare, genetic blood disease.

Just as the panel was about to vote for the recommendation against using the drugs in kids 12 and under, she pointed out that parents “will administer adult products to their children because they know they work for them, or they feel they work for them, and I have significant concerns what will happen if they are completely gone.”

That statement led to the compromise — the recommendation against sales for kids under 6.

But these panels only offer advice. It is up to the FDA to make the decision, and a ban for the under 6 age group is unlikely to be enacted for at least a year — if ever. 

A week before the FDA panel meeting, the industry voluntarily withdrew cold products for children under 2. But the drug manufacturers, including Johnson & Johnson and Novartis, have promised to fight restrictions on sales to older kids (a much bigger market) in court, if necessary. That could delay action for years.

MSNBC video   FDA: Cold medicine not proven effective for kids Oct. 19: An FDA advisory panel says that cough and cold medicines have not been proven effective for children under the age of 12. NBC's Robert Bazell reports. MSNBC

Overdose risks
While the FDA is preparing its response to the advisory committee, parents would be well advised to pay attention to some other issues that were raised.

It turns out there are only a few key ingredients in all these cough and cold medicines and they are mixed in different combinations and varying brands and doses to come up with the 800 products. This can be a big problem when parents use different products simultaneously. They could unknowingly give their children double or triple the dose of an ingredient that can be hazardous in large quantities.

In fact, the bewildering array of instructions, labels and dosing presents a huge mess that many panel members believe should be cleaned up. Until then, parents would be smart to stick to cough or cold products with a single active ingredient and pay close attention to the dose.

Using them as sedatives
Finally, the panelists heard repeatedly that colds and coughs in children occur regularly and they almost always get better with no treatment. 

The biggest open secret with these medicines is that often parents use them as sedatives to get themselves and their children a good night’s sleep. This is especially common with diphenhydramne, the main antihistamine ingredient in Benadryl, and a component of many other medications. This is not a recommended use and it can be dangerous, the panelists heard.

“How do I advise parents to dose these medications?” quipped pediatrician Dr. Daniel Levy, clinical assistant professor of pediatrics at the University of Maryland, College Park. “I ask them to unscrew the top of the bottle, and, in one easy motion, invert it over the toilet.”

Many parents might not want to go that far. But they should remember that these products are unproven, kids do get better on their own and the drugs can have risks.

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