A new CDC study says that ED visits due to adverse events from cold medicines dropped significantly among young children after a voluntary product withdrawal.
New research from the CDC indicates that US emergency department (ED) visits due to adverse events from cough and cold medicines declined substantially among children younger than two years old after a voluntary withdrawal of nonprescription infant products in 2007.
The product withdrawal of orally administered, over-the-counter cough and cold medications (CCMs) labeled for infants was announced in October 2007 because of concerns regarding limited evidence of efficacy and potential harmful effects of these products among young children.
In the study, which is published in Pediatrics, Daniel S. Budnitz, MD, MPH, of the CDC’s Division of Healthcare Quality Promotion, and colleagues assessed changes in CCM-related harm, as measured with national estimates of ED visits for CCM-related adverse events, among children <12 years of age from a nationally representative sample of 63 EDs.
In the 14-month period after announcement of the withdrawal of orally administered, over-the-counter CCMs for infants, the number and proportion of estimated ED visits for CCM-related AEs involving children <2 years of age were less than half of those in the pre-withdrawal period (1,248 visits compared to 2,790 visits). At the same time, the overall number of estimated ED visits for CCM-related AEs for children <12 years of age remained unchanged (9,408 visits versus 9,727 visits). During both time periods, most ED visits for CCM-related AEs involved children 2 to 5 years of age, and boys accounted for a nominally greater number of ED visits, according to the authors.
Another key finding from the study is the fact that both before and after the product withdrawal, about two-thirds of all ED visits for cough and cold medicines were the result of unsupervised ingestions by children. Further reductions in ED visits will likely require packaging improvements, as well as continued education about avoiding CCM use for young children.
“The use of CCMs for children remains an important concern in the medical and public health communities,” said authors, who urge continued monitoring of CCM-related harm, particularly since recommendations were updated in October 2008 to avoid the use of CCMs for children <4 years of age.
The study, they noted, is the first of its kind to assess, based on active surveillance, the changes in the national burden and scope among children of CCM-related AEs and AEs related to medications potentially substituted for infant CCMs since the announcement of the withdrawal. These findings “have important implications for continued efforts to reduce the burden of harm resulting from these medications,” the authors said.
To read the study—Adverse Events from Cough and Cold Medications after a Market Withdrawal of Products Labeled for Infants—click here.
These findings suggest that voluntary product withdrawals can lead to a significant decrease in ED visits. What do you feel is the most effective method for communicating this information to patients and their families?