More Discussion of Over the Counter Cough and Cold Preparations

We appreciate the opportunity to read and comment on a recent publication in Annals by Dart et al regarding potential toxicity from over the counter cough and cold preparations,1 a group of medications that has never shown much clinical efficacy in children. This topic has been commonly found in both the lay press and medical publications of late, and this work will no doubt add to our knowledge. However, we believe it is prudent to point out some issues regarding the article's findings. First, although the authors amassed 118 cases judged possibly, likely, or definitely related to the cough and cold ingredients, it should be emphasized that this number was reported over a 50-year period, and not one of these were judged by the expert panel of reviewers to have occurred with “therapeutic” dosing of the products. All cases reported involved either “supratherapeutic” doses (75%), or the dose was unknown. Some of these supratherapeutic doses were intentionally administered for reasons other than symptom relief, such as for sedation or suspected homicide. Other cases were likely unintentional ingestions by young children of excessive doses. It is possible that the take-home message from these findings is not that these drugs are inherently dangerous in young children in recommended doses, but that overdosing these, like other over the counter medications including acetaminophen and salicylate, can be fatal.

Decreasing exposures to and ultimately fatalities from over the counter pharmaceuticals can be accomplished several ways. First, engineering and technological advancements in packaging and precise dosing may decrease unintentional ingestions and overdose. Second, educational awareness can be improved, for example by making parents more informed of the consequences of supratherapeutic dosing. Finally, government regulation can reduce potential exposure. This can be accomplished most abruptly by removing the agent from over the counter store shelves and controlling access, but also by removing specific ingredients from over the counter products, or by making recommendations to health care providers, such as the Food and Drug Administration did in this case. It is interesting to note that the 2007 collective data reported by US poison centers recorded similar numbers of childhood fatalities from cough and cold preparation and from over the counter analgesics, with many more exposures to over the counter analgesics.2 Advances have been made in packaging and dispensing technology of over the counter analgesics that may have improved safety, and it is possible that these types of innovations could be applied to over the counter cough and cold preparations. This may permit ongoing over the counter status of these agents, especially since large numbers of parents prefer to continue to administer them to children.3

Lastly, it should be remembered that the most important conclusion of reviewing groups looking at the over the counter cough and cold medications in children was that they may be ineffective.4 This would seem to be a more prudent argument limiting their use or availability than showcasing their toxicity, especially in therapeutic doses.