In 2005, a national database of poisoning cases recorded more than 85,000 calls regarding reactions from the overdosing of young children with over-the-counter (OTC) antihistamines or cough and cold medicines.
And an FDA review of deaths among children between 1969 and 2006 found reports of 54 deaths from decongestants and 69 deaths from antihistamines, mostly in children under age 2.
The pharmaceutical companies themselves are beginning to show concern about this. On October 11, the Consumer Healthcare Products Association announced that,"out of an abundance of caution," the makers of several leading over-the-counter cold medications voluntarily withdrew their products sold for infants.
You might ask how parents can be dumb enough to give their young children overdoses of these medications. But don't judge so quickly. The doses on the drug labels are based on extrapolations from adult doses rather than from actual studies in children themselves, which would be unethical. And labels do not even give doses for children under 2 years of age. In addition, these products are found in so many OTC preparations that it is easy to overdose by unwittingly giving two different remedies that both contain the same drug.
After a recent spate of articles warning against use of cold remedies in young children, the FDA said that the media had "jumped the gun" by citing a 365-page Public Health Advisory posted on its Web site. Although the Advisory did indeed say that the cold remedies could be unsafe, it contained views of the staff that were not yet official.
In any case — whether these warnings are officially from the FDA or not — parents should be heed them. Not only do these medicines pose risks to children, but a number of small studies also indicate that they may not be effective in relieving their cold symptoms. If you are caring for young children, be on the lookout for the many popular children's remedies that contain the following drugs, either alone or in combination:
- the antihistamines diphenhydramine and bromopheniramine
- the decongestants phenylephedrine and pseudoephedrine
- the cough suppressant dextromethorphan
- the expectorant guaifenesin
These remedies probably should not be used in children under the age of 6, and for certain not in those less than 2.
After reading the newspaper article, I was reminded that in our medicine cabinet was a small bottle of Children's Benadryl®, which contains the antihistamine diphenhydramine. We have given this product to our grandson, who is not yet 3, for skin reactions caused by his allergy to eggs — children do benefit from antihistamines when these drugs are given for allergic reactions rather than for colds.
We will have to wait some time to learn whether the FDA removes some of these products from the market, adds stern warnings about their risks to the labels, or possibly avoids addressing the issue altogether.
