(RxWiki News) Medicine is meant to heal, but sometimes even over-the-counter products can have unintended effects. A new study focused on such a situation involving young children and cold medicine.
This study explored emergency visits for certain cough and cold medications after label changes to these products were made several years ago.
The researchers found that the label changes seemed to have reduced the number of emergency room visits for young children related to the medications.
"Ask a doctor about medicine for young children."
According to the study authors, led by Lee M. Hampton, MD, MSc, of the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, manufacturers of over-the-counter infant cough and cold medications in the US withdrew the products from the market in October 2007.
The manufacturers later announced (in October 2008) labeling changes for the products that warned against use of over-the-counter infant cough and cold medications for children under the age of 4.
Dr. Hampton and colleagues set out to study if emergency department visits related to adverse drug events (ADEs) went down after these changes were made. To do so, they utilized data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project, which involved 63 hospitals across the nation.
The researchers looked at the data from 2004 to 2011 and estimated the number of emergency department visits for ADEs related to cough and cold medicines. Numbers from before and after the products' withdrawal from the market and before and after label changes were examined.
Dr. Hampton and colleagues found that emergency department visits by children under 2 for ADEs related to cough and cold medications dropped from 4.1 percent of all ADE emergency visits before the withdrawal to 2.4 percent of all ADE emergency visits after.
For children aged 2 to 3, the cough and cold medicine ADE visits dropped from 9.5 percent of all ADE emergency visits before the withdrawal to 6.5 percent of all ADE visits after.
The researchers also found that unsupervised ingestions of the medicines accounted for 64.3 percent of the cough and cold medicine ADE emergency department visits for children under the age of 2 after the medicines were withdrawn from the market. After the label changes, unsupervised ingestions accounted for 88 percent of ADE visits for children aged 2 to 3.
Dr. Hampton and team noted that while emergency visits related to intentional ingestion of the medicines seemed to drop significantly after the product withdrawal and changes, efforts still need to be made to reduce ADEs related to young children ingesting the medicine while unsupervised.
This study was published in the December issue of Pediatrics. No conflicts of interest were reported.