Oct. 22, 2007 -- Would you give an over-the-counter cold or cough medicine to your 5-year-old child?
Before last week, most of us would have said "yes." Indeed, a 1994 study found that in a given month, more than a third of U.S. 3-year-olds were getting a dose of cold or cough medicine. Now more than 30 of these preparations are marketed for children.
But by a 13-9 vote, an FDA advisory committee says these medicines should never be given to kids under age 6. The FDA is not required to obey its advisory committees. Until the FDA acts, the products will remain on drugstore shelves (except for cough/cold products aimed at kids under age 2, which the industry voluntarily withdrew from market before the committee met).
WebMD's message boards have buzzed with questions and comments from concerned parents. To respond, WebMD spoke with two experts.
One is Ian Paul, MD, associate professor of pediatrics at Penn State Children's Hospital. Paul is a member of the American Academy of Pediatrics' executive committee on clinical pharmacology and therapeutics.
The other is Michael Shannon, MD, MPH, professor and chairman of emergency medicine at Children's Hospital Boston and Harvard Medical School. Shannon is one of the 16 leading pediatricians and public health experts who petitioned the FDA to stop the marketing of cough and cold medicines to young children.
Your questions and the experts' answers:
When they say "cold and cough medications," what types of drugs are they talking about?
We are talking about four different medications. The first is a cough suppressant, dextromethorphan or DM. Second are the decongestants,pseudoephedrineand phenylephrine. Third is the expectorant, guaifenesin. And fourth are the antihistamines: brompheniramine, chlorpheniramine maleate, diphenhydramine -- Benadryl -- and others.
Aren't any of these types of drugs effective?
None has been shown effective for children. There are some data showing that pseudoephedrine, a decongestant, has some efficacy in adults. For the rest, the data are pretty weak and the effect size is pretty small. There is mixed data in adults, and you can question whether this means there it is a clinically significant effect. But those tested in children are not shown to be superior to inactive placebo.
The fact of the matter is, regardless of age, cough and cold preparations are ineffective. There is one study in adults, that the industry produces, showing that if you give cough and cold medicine to an adult you can expect about a 6% improvement. That is pretty doggone small. I interpret that and the rest of the medical literature to mean these products don't work in older children or adults, either.
In our petition we were interested in children under age 6 because there is where we saw the most problems, particularly in those under 2 years of age. The FDA panel chose not to take a position on children over 6, but in our petition we didn't ask them to. When they asked us, we said these medications are still not effective, but may be a little safer in older children.
But I gave these drugs to my children when they had colds and they worked. How can you say they don't?
Even though parents and some pediatricians believe these products work, science has proven that they don't. The studies show that these drugs don't work any better than inactive placebo. In fact, placebo worked better in one study. Treated children got better because colds get better over time.
A lot of parents may have had the impression these drugs were working. But if they gave them a sweet, syrupy liquid, they might have done just as well. So No. 1, it is a large placebo effect. No. 2, for our whole lives we have been told these drugs work. And No. 3, we all got better from every cold we ever had -- so we are apt to believe the drugs helped. But if people take an inactive placebo, they would get just as well, just as fast.
Are all of these types of drugs dangerous?
Any medicine we give to any child has the potential for side effects. The issue here is the risk/benefit relationship. So if we have medicines not proven effective, any side effect is too great.
Are any of these drugs particularly dangerous?
Because the antihistamines I mentioned [brompheniramine, chlorpheniramine maleate, and diphenhydramine] are sedating, they can be dangerous to young children already having breathing difficulties. And the decongestant pseudoephedrine could be dangerous to children with heart conditions, whether or not those conditions have yet been diagnosed.
These drugs have been on the market for years. Why take them away now?
There has been increasing evidence of lack of effectiveness and of some serious side effects. This raises the question of whether they should remain available for the treatment of cough and cold. There is a place for antihistamines in the treatment of children's allergy and allergic reactions.
This issue could have and should have been addressed a long time ago. The data showing lack of effectiveness have been around for more than five years. The answer to your question, from our perspective, is the number of deaths and adverse events in children continued to mount so much the issue could not continue to be ignored. It was OK not to start a battle over the drugs being ineffective, but it became mandatory to become vocal when it became clear they were unsafe.
If the harmful effects of these drugs are due to overdose, why can't the FDA trust me to read the labels if I opt to give these medicines to my child?
I think this is the most important misconception about this issue. The fact of the matter is these adverse events are not confined to overdose. While the majority of these events and deaths were the results of overdose, a significant percentage were unexpected effects or exaggerated effects in children who had underlying illnesses or who were taking other drugs the cold drugs interacted with. No amount of better labeling, better education, or better poison prevention would prevent that.
A lot of the health decisions we make are on a population-based risk. If you look at population of young children as a whole, the side-effect profile -- given lack of benefit -- is unacceptable. In the middle of the night, even smart parents could overdose their children. If a mother gives a child a dose and doesn't tell the dad, an overdose can happen. There are so many ways misdosing can happen.
This is going to be very difficult for many families. It is hard not to have something available to give a suffering child. But if parents bear with the community of physicians and the FDA and the pharmaceutical companies, I expect a lot of research to happen in the near future. That is how we will find safe, effective cold and cough drugs with proper dosing for children.
Won't this make things even more dangerous, as parents will simply start buying adult versions of the drugs and guessing at child dosages?
We hope that won't happen. It is a concern that parents would turn to adult doses or alternative remedies that could be dangerous. Hopefully there will be a lot of education to prevent that from happening.
It would be a very significant mistake for parents to do that. The mistake is thinking you can take a medicine meant for an adult, by simple math calculate a similar dose for a child, and expect a similar effect. The other real risk here is that a lot of these adult products have ingredients that really are not made for children -- such as alcohol. You could give a child alcohol poisoning.
Wouldn't clearer, easier-to-read labels solve this problem?
Yes, it would. But if it were that easy, the drug companies would have done that a long time ago. Even medical professionals have trouble saying the names of these compounds. And from one company to the other, the labels give information in different ways. An alternative would be to require cold medicines to contain just one drug, and to call them by the drug name rather than by a brand name -- but that isn't likely to happen.
Can my pediatrician prescribe cold and cough medicines for my child?
There aren't any. There simply aren't any medications proven to improve the congestion or cough of a cold.
At this time, there is nothing to prescribe for the common cold, other than waiting a couple of days.
If we can't use these products, what are we supposed to do when our little ones are sick?
You can give them a non-aspirin pain reliever, acetaminophen or ibuprofen. You can give them saline nose drops or spray. You can use an air humidifier in their bedrooms. And you can make sure they drink plenty of fluids.
OK, so maybe cold medicines don't relieve cold symptoms. But they help my child sleep. What's wrong with that?
I am discovering that for many parents, the sole reason and the sole goal of using cold medicine was to give their child a sedative. That really concerns me. One, that does nothing to improve the symptoms of cough or shorten duration of illness. And No. 2, it is never a good idea to sedate a child if you don't have to, because sedatives have their own set of safety risks. We pediatricians have our work cut out for us in terms of making sure we do a better job of helping parents treat this really common illness. We must reinforce the idea that the goal of treatment is not to just put the kids out. That is not a good approach.