Kids & Cold Drugs: Questions, Answers
Experts Answer Your Questions About Children's Cough and Cold Medicines
WebMD News Archive
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
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.