1. The proportion of emergency department (ED) visits due to adverse drug effects (ADEs) in young children from infant cough and cold medications (CCMs) compared to other medications has decreased since withdrawal and relabeling interventions in 2007 and 2008, respectively.
2. Following the 2008 label revisions, ADEs due to unsupervised ingestions of CCMs in children ages 2-3 years experienced a smaller decline (24%) than those due to supervised administration (54%). Similarly, ADEs due to unsupervised ingestions accounted for 64% and 88% of ADE ED visits after withdrawal and relabeling interventions, respectively.
Evidence Rating Level: 2 (Good)
Study Rundown: Adverse drug effects (ADEs) due to cough and cold medications (CCMs) have been associated with emergency department (ED) visits in children and even infant deaths. In light of these known risks, in 2007, over-the-counter (OTC) infant CCMs for children < 2 years old were withdrawn voluntarily. One year later, in 2008, CCM labels were revised to state that they should not be used in children < 4 years old. This study assessed whether these interventions were associated with changes in ED visits for CCM ADEs in children. Results indicated that the proportion of CCM-related ADEs have decreased since withdrawal and relabeling interventions in 2007 and 2008. However, ADEs due to unsupervised ingestions of CCMs in children ages 2-3 years experienced a smaller decline (24%) than those due to supervised administration (54%), following label revisions. Furthermore, ADEs due to unsupervised ingestions accounted for 64% and 88% of ADE ED visits after withdrawal and relabeling interventions, respectively. Data from this study do not include ADE cases that were not in the ED, which may have limited the results. Still, because CCM-related ED visits have not been completely eliminated, and because this study links unsupervised ingestions to most CCM ADEs, efforts must be made to limit young children’s access to medications, such as safer medication handling and storage in the home.
Relevant Reading: Toxicity of Over-the-Counter Cough and Cold Medications
Study Author, Dr. Lee Hampton, MD, talks to 2 Minute Medicine: Medical Officer, Division of Healthcare Quality Promotion, CDC.
“The 2007 withdrawal of over-the-counter infant cough and cold medications and the 2008 addition of a warning against use by young children to over-the-counter cough and cold medication packages were associated with reductions in emergency department visits for adverse events caused by these medications among young children, especially adverse events resulting from caregivers giving medications to children. However, in recent years the vast majority of emergency department visits for cough and cold medication adverse events have been due to children getting into these medications when they were not supposed to.
Efforts to reduce cough and cold medication adverse events among children need to focus on preventing children from accessing such medications without supervision. Clinicians can help by counseling adults to keep medications up and away and out of sight, to properly lock child-resistant caps after every use, and to not give cough and cold medications to children <4 years old.”
In-Depth [retrospective analysis]: Data were collected from 58 general hospitals and 5 pediatric specialty hospitals as part of the National Electronic Injury Surveillance System-Cooperative ADE Surveillance (NEISS-CADES) project. ED visits by patients < 12 years of age who were seen for an ADE-related reason from January 1, 2004 to December 31, 2011 were considered for analysis. From there, cases were classified as either “unsupervised ingestions” that lacked adult supervision, or “supervised administrations,” those provided by a caregiver. Between 2004 and 2011, there were 61 168 CCM ADE-related ED visits involving children < 12 years of age, with CCMs being the only medication implicated in 93.4% of visits and OTC CCMs accounting for 76.6% of visits. Following the 2007 withdrawal of OTC infant CCMs, ED visits for CCM-induced ADEs for children < 2 years old decreased by 41% (difference in proportions: -1.7%, 95% CI: -2.7% to -0.6%). Specifically, ADE-related ED visits decreased by 55% for supervised administration (difference in proportions: -1.8%, 95% CI: -2.9% to -0.6%), while unsupervised ingestion ADEs did not decrease significantly. Similarly, following the 2008 relabeling intervention of CCMs, ED visits for ADEs for children ages 2 to 3 years decreased by 54% for supervised administration (difference in proportions: -2.9%, 95% CI: -5.4% to -0.5%), while unsupervised ingestions declined by only 24% (difference in proportions: -2.6%, 95% CI: -5.3% to -0.01%). ADEs due to unsupervised ingestions accounted for 64% and 88% of ADE ED visits after the withdrawal and relabeling interventions, respectively. Interrupted time series analysis revealed similar trends.
By Cordelia Y. Ross and Leah H. Carr
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