{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T04:58:36Z","timestamp":1791176316679,"version":"4.1.0"},"reference-count":36,"publisher":"American Academy of Pediatrics (AAP)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2013,12,1]]},"abstract":"<jats:sec>\n                  <jats:title>BACKGROUND:<\/jats:title>\n                  <jats:p>In October 2007, manufacturers voluntarily withdrew over-the-counter (OTC) infant cough and cold medications (CCMs) from the US market. A year later, manufacturers announced OTC CCM labeling would be revised to warn against OTC CCM use by children aged &amp;lt;4 years. We determined whether emergency department (ED) visits for CCM adverse drug events (ADEs) declined after these interventions.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>METHODS:<\/jats:title>\n                  <jats:p>We used National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance data from 2004 to 2011 to estimate the number of ED visits for CCM ADEs before and after each intervention.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS:<\/jats:title>\n                  <jats:p>Among children aged &amp;lt;2 years, ED visits for CCM ADEs decreased from 4.1% of all ADE ED visits before the market withdrawal to 2.4% of all ADE visits afterward (difference in proportion: \u20131.7%, 95% confidence interval [CI]: \u20132.7% to \u20130.6%). Among children aged 2 to 3 years, ED visits for CCM ADEs decreased from 9.5% of all ADE ED visits before the labeling revision announcement to 6.5% of all ADE visits afterward (difference in proportion: \u20133.0%, 95% CI: \u20135.4% to \u20130.6%). Unsupervised ingestions accounted for 64.3% (95% CI: 51.1% to 77.5%) of CCM ADE ED visits involving children aged &amp;lt;2 years after the withdrawal and 88.8% (95% CI: 83.8% to 93.8%) of visits involving children aged 2 to 3 years after the labeling revision announcement.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS:<\/jats:title>\n                  <jats:p>After a voluntary market withdrawal and labeling revision, ED visits for CCM ADEs declined among children aged &amp;lt;2 years and 2 to 3 years relative to ADE ED visits for all drugs. Interventions addressing unsupervised ingestions are needed to reduce CCM ADEs.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1542\/peds.2013-2236","type":"journal-article","created":{"date-parts":[[2013,11,12]],"date-time":"2013-11-12T01:56:19Z","timestamp":1384221379000},"page":"1047-1054","source":"Crossref","is-referenced-by-count":41,"title":["Cough and Cold Medication Adverse Events After Market Withdrawal and Labeling Revision"],"prefix":"10.1542","volume":"132","author":[{"given":"Lee M.","family":"Hampton","sequence":"first","affiliation":[{"name":"Division of Healthcare Quality Promotion, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Duc B.","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Division of Healthcare Quality Promotion, and"},{"name":"Epidemic Intelligence Service, Scientific Education and Professional Development Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan R.","family":"Edwards","sequence":"additional","affiliation":[{"name":"Division of Healthcare Quality Promotion, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel S.","family":"Budnitz","sequence":"additional","affiliation":[{"name":"Division of Healthcare Quality Promotion, and"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2013,12,1]]},"reference":[{"issue":"6","key":"2021120823380355100_B1","doi-asserted-by":"crossref","first-page":"1100","DOI":"10.1542\/peds.2010-1839","article-title":"Adverse events from cough and cold medications after a market withdrawal of products labeled for infants.","volume":"126","author":"Shehab","year":"2010","journal-title":"Pediatrics"},{"key":"2021120823380355100_B2","unstructured":"Consumer Healthcare Products Association. Makers of OTC cough and cold medicines announce voluntary withdrawal of oral infant medicines. Available at: www.chpa-info.org\/10_11_07_OralInfantMedicines.aspx. Accessed June 7, 2013"},{"key":"2021120823380355100_B3"},{"key":"2021120823380355100_B4"},{"key":"2021120823380355100_B5","doi-asserted-by":"crossref","unstructured":"Gunn VL, Taha SH, Liebelt EL, Serwint JR. Toxicity of over-the-counter cough and cold medications. Pediatrics. 2001;108(3).Available at: www.pediatrics.org\/cgi\/content\/full\/108\/3\/e52","DOI":"10.1542\/peds.108.3.e52"},{"key":"2021120823380355100_B6","unstructured":"Food and Drug Administration. Nonprescription Drug Advisory Committee Meeting\u2014cold, cough, allergy, bronchodilator, antiasthmatic drug products for over-the-counter human use, October 18 and 19, 2007. Available at: www.fda.gov\/ohrms\/dockets\/ac\/07\/briefing\/2007-4323b1-02-FDA.pdf. Accessed May 3, 2010"},{"issue":"23","key":"2021120823380355100_B7","doi-asserted-by":"crossref","first-page":"2321","DOI":"10.1056\/NEJMp0707400","article-title":"Over the counter but no longer under the radar\u2014pediatric cough and cold medications.","volume":"357","author":"Sharfstein","year":"2007","journal-title":"N Engl J Med"},{"issue":"1","key":"2021120823380355100_B8","first-page":"1","article-title":"Infant deaths associated with cough and cold medications\u2014two states, 2005.","volume":"56","author":"Centers for Disease Control and Prevention","year":"2007","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2021120823380355100_B9","unstructured":"Food and Drug Administration. News & Events\u2014FDA releases recommendations regarding use of over-the-counter cough and cold products. Products should not be used in children under 2 years of age; evaluation continues in older populations. 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