@article{ref1,
title="Adverse Events From Cough and Cold Medications After a Market Withdrawal of Products Labeled for Infants",
journal="Pediatrics",
year="2010",
author="Shehab, Nadine and Schaefer, Melissa K. and Kegler, Scott R. and Budnitz, Daniel S.",
volume="126",
number="6",
pages="1100-1107",
abstract="Objective: A voluntary market withdrawal of orally administered, over-the-counter, infant cough and cold medications (CCMs) was announced in October 2007. The goal of this study was to assess CCM-related adverse events (AEs) among children after the withdrawal. Methods: Emergency department (ED) visits for CCM-related AEs among children <12 years of age were identified from a nationally representative, stratified, probability sample of 63 US EDs, for the 14 months before and after announcement of withdrawal. Results: After withdrawal, the number and proportion of estimated ED visits for CCM-related AEs involving children <2 years of age were less than one-half of those in the prewithdrawal period (1248 visits [13.3%] vs 2790 visits [28.7%]; difference: -15.4% [95% confidence interval [CI]: -25.9% to -5.0%]), whereas the overall number of estimated ED visits for CCM-related AEs for children <12 years of age remained unchanged (9408 visits [95% CI: 6874-11 941 visits] vs 9727 visits [95% CI: 6649-12 805 visits]). During both periods, two-thirds of estimated ED visits involved unsupervised ingestions (ie, children finding and ingesting medications). Conclusions: ED visits for CCM-related AEs among children <2 years of age were substantially reduced after withdrawal of over-the-counter infant CCMs. Further reductions likely will require packaging improvements to reduce harm from unsupervised ingestions and continued education about avoiding CCM use for young children. Monitoring of CCM-related harm should continue because recommendations were updated in October 2008 to avoid the use of CCMs for children <4 years of age.<p /> <p>Language: en</p>",
language="en",
issn="0031-4005",
doi="10.1542/peds.2010-1839",
url="http://dx.doi.org/10.1542/peds.2010-1839"
}