Johnny has a bad cold. His nose won't stop running. He keeps coughing and it's hard for him to sleep at night because his nose is so stuffed up. Is it safe to give him an over-the-counter cough and cold medication (CCM)? Researchers looked at how safe these are when used for children younger than 12 years old in a Pediatrics study earlier this summer.
Before 2007, about 10 percent of U.S. children were using CCMs every week. The highest use was in children younger than 5 years of age. In 2007, a citizen's petition raised concerns about the safety and effectiveness of CCMs, and claimed that professional organizations and agencies had the same concerns. At the time, there was limited scientific data to address these concerns.
Regardless, this led to voluntary relabeling of CCMs with "do not use in children less than 4 years old," withdrawal of the concentrated infant formulations, and reminders from the U.S. Food and Drug Administration to never use CCMs in children less than 2 years of age. Statements from representatives of the American Academy of Pediatrics supported these actions. Despite these events and warnings, caregivers continue to give these medications to young children and some medical providers continue to recommend their use — even in young children. U.S. consumers continue to spend more than $5 billion a year on these products.
In 2008, the Pediatric Cough and Cold Safety Surveillance System was launched to assess the safety of CCMs by collecting data from five different national sources on significant adverse events associated with the use of these products in children less than 12 years of age.
The researchers found 3,251 reported cases of adverse events related to CCMs from 2009-2014. The most common adverse events in more than two-thirds of cases were from accidental unsupervised ingestions (AUIs), and medication errors (13 percent). Almost 46 percent of the events involved children 2 to 4 years of age, and the majority were from AUIs. The most common active ingredients mentioned were diphenhydramine and dextromethorphan. The most common adverse events were transient, and included rapid heart rate, sleepiness, hallucinations, unsteady gait, dilated pupils, and agitation. There were 20 (0.6 percent) deaths, of which two were from AUIs, two from medication errors, and the rest were for other reasons.
Adverse events from pediatric use of CCMs were uncommon, at a rate of 1 case per 1.75 million units sold. The rate of AUIs was five times that of medication error cases. This study suggests that adverse events from CCM use in children are not related to their use per se, but from the risk of having young children accidentally ingesting them because of their availability at home, much like acetaminophen and ibuprofen accidental ingestions by young children are common because they are kept in most households.
This research showed that outside of young children accidentally taking CCMs, the risk of their use is low. But do they really work? This study did not assess the effectiveness of these products, and the current available scientific data are inadequate to answer this question. Colds from viruses are self- limited and eventually get better. CCMs treat the symptoms of colds and not the underlying disease.