Decongestants and cold medications for young children are no longer recommended for children < 4years of age due to serious side effects that led to this recommendation by the Food and Drug Administration to institute package labeling saying usage is contraindicated in our youngest patients. But since they are still found over the counter on shelves in grocery and drug stores, should we be concerned about their ongoing risks to children of all ages? Just how safe are they? Green et al. (10.1542/peds.2016-3070) opted to look into this question by collecting cases of adverse events from the use of a cough and cold medication in children less than 12 years of age. The authors reviewed more than 4000 cases to determine if the adverse event might have been related to an active ingredient in a particular cold or cough medication and how that event might have occurred. To no real surprise, a high number of cases were due to unsupervised ingestions (67%) and medication errors (13%) with a variety of adverse events reported, ranging from tachycardia and agitation to somnolence and hallucinations. Single ingredient preparations had more complications than the multiple—probably because dosages in the combination products tend to be lower than therapeutic to reduce risk of side effects when multiple drugs are combined in one medication.
Sadly, 20 cases (1%) resulted in the death of a child—the majority of which occurred in children less than two who received a higher therapeutic dose than would have been recommended by weight. The good news from reading this study is that adverse events are not common if the therapeutic dose is adhered to. The bad news is that adverse events, sometimes fatal ones, can and do occur especially if children gain access to these medications and ingest them at higher doses in unsupervised accidental situations. As to which drugs cause a problem and which do not, and what ingredients in cough and cold preparations cause the most problem—check out this study and share your findings with your patients. You’ll find the information nothing to sneeze at.
