Fortnightly features' series: Children's Cold Medicine

The issues deliberated

The controversy over commonly available, over-the-counter, children’s cold medicines had been brewing in the United States for over 2 weeks now, following a meeting of a high profile FDA panel of experts recommending against the use of these medicines for children under the ages of 6.

 

This situation was brought about by the lack of data supporting efficacy for these products for the patients that they are being marketed for.

 

"The data that we have now is they don't seem to work," said Sean Hennessy, a University of Pennsylvania epidemiologist, one of the FDA experts gathered.

 

While the consensus is that they shouldn’t be used in children under the age of 6, there isn’t enough evidence to show that they work in older kids too. The jury is still out on eliminating their use in children under 12.

 

The expert panel are pushing for further evaluation and studies of medicines long used to treat common cold symptoms. The non-binding recommendation applies to medicines containing one or more of the following ingredients: decongestants, expectorants, antihistamines and antitussives.

 

What’s going to happen?

Some manufacturers have already pulled various products for the lower age groups off the shelves in anticipation of FDA’s decision. However, the drug industry is vehemently contesting the safety and restrictions on sales of these products to this market.

 

Although the FDA does not have to comply with the recommendations of its expert panels, it usually does so most of the time. Besides restudying these drugs, FDA may impose a stricter drug labelling for these products to reflect the new recommendations.

 

What are the drugs affected?

The drugs at the centre of this furore include Dimetapp Decongestant Plus Cough Infant Drops, Dimetapp Decongestant Infant Drops, Little Colds Decongestant Plus Cough, Little Colds Multi-Symptom Cold Formula, Pediacare Infant Drops Decongestant, Pediacare Infant Dropper Decongestant, Pediacare Infant Dropper Long-Acting Cough, Pediacare Infant Dropper Decongestant & Cough, Robitussin Infant Cough DM Drops, Triaminic Infant & Toddler Thin Strips Decongestant, Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough, Tylenol Concentrated Infants' Drops Plus Cold and Tylenol Concentrated Infants' Drops Plus Cold & Cough. - have never been tested in children, something flagged as long ago as 1972 by a previous FDA panel.

 

The situation at home

It may be assuring for local parents to know that none of these formulations are licensed or available in Singapore.

 

While there have been reported adverse events from the FDA associated with the use of antihistamines and decongestants in children under 2 years of age, there has not been any such fatal drug reactions reported in Singapore.

 

Parents in Singapore should consult their children’s doctors if they are unsure about this issue and with the flu season coming up, it would be wise to consider some precautionary actions, such as flu vaccination.

The following table highlights some general recommendations for parents when checking out their children’s medicines

 

Active Ingredient	Below 6 months	6 months-2 years	Above 2 years
Promethazine	Do not use	Not recommended	Cautionary use
Antihistamines   (Brompheniramine, Chlorpheniramine, Diphenhydramine)	Not recommended	Use when benefits are well established by doctor	Cautionary use
Cough Suppressants   (Codeine, Dextromethorphan, Diphenhydramine)	Not recommended	Use when benefits are well established by doctor	Cautionary use
Cold & Flu Products   (Pseudoephedrine, Ephedrine, Guaifenesin, Phenylephrine)	Not recommended	Use when benefits are well established by doctor	Cautionary use

 

 

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