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Cold drug debate could take years to shake out

/ Source: NBC News

It brought widespread shock and disbelief.

Parents across the country heard last week that there is no evidence that widely used over-the-counter medications do any good for common cold symptoms in children. A Food and Drug Administration panel of experts said that the drugs shouldn't be given to children under 6.

Blogs lit up with parents flatly declaring that taking away these products would amount to government intrusion into their common sense. But parents should relax. Nothing will change for years, if ever.

The surprise is understandable. According to the New York Times, there are about 800 cough and cold preparations for children available in the United States. Parents spend almost $500 million on some 95 million boxes that they use to dispense 3.8 billion doses a year. In one month alone, fully one-third of all the 3-year-olds in the country got at least one dose of a cough or cold medicine, a 1994 study found.

Heavy marketing

How could this be if the drugs are no good?

Industry representatives raised that point many times during the two days of FDA panel hearings. “If these medicines are allegedly not effective or materially unsafe, how is the purchase of hundreds of millions of doses explained?” asked panel member Dr. George Goldstein, a pharmaceutical industry consultant.

“It is marketing,” replied Dr. Richard Neill, a family medicine physician with the University of Pennsylvania Health System. During the hearings panel members saw numerous examples of packaging and ads for the medicines, all picturing happy infants and toddlers.

Heavy marketing is certainly a big factor in the use of these medicines — as it is with many other over-the-counter drugs.

But this issue also has a long history. Most of the ingredients in cough and cold medicines, for both children and adults, have been around for decades — so long that they did not have to meet the standards that would apply for a drug coming to market today.

'Not little adults'

In the 1960s the FDA drew up a list of ingredients used in older drugs that were “generally recognized as safe and effective.” Over-the-counter cough and cold medicines fell into that category.

When it came to treating children, two prevailing views dominated the thinking of pediatricians and pharmacologists at that time and into the ‘70s. First, if a drug worked in adults, it was fine to give it to children at lower doses. The usual formula was: half a dose for children ages 6 to 12; a quarter for those 2 to 6; and an eighth for those under 2. A second view held it was unethical to perform experiments on children.

Since then, the conventional wisdom has shifted 180 degrees. At last week’s hearings, it was often heard that “children are not little adults.” Kids often metabolize drugs differently from adults and show different reactions. Experts now believe that, with proper safeguards, studies can and should be carried out on children.

The problem is not that large, well-conducted studies show the drugs fail to work in children. The issue is a lack of evidence one way or the other. As a result, the panel asked the FDA to compel companies to set up studies to find the answers.

The panel came very close to recommending that the medications not be used in kids under 12 based on the the lack of proof that they work, combined with the clear evidence that — in rare cases — the medications can cause serious side effects, even an occasional death. Dr. Robert  Daum, pediatric infectious disease specialist at the University of Chicago, said, "If there is no evidence of efficacy, I can't support the use of” the medicines in children.

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.

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.