{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T09:42:53Z","timestamp":1784194973544,"version":"3.55.0"},"reference-count":31,"publisher":"American Academy of Pediatrics (AAP)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2010,12,1]]},"abstract":"\n OBJECTIVE:<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n METHODS:<\/jats:title>\n Emergency department (ED) visits for CCM-related AEs among children &lt;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.<\/jats:p>\n <\/jats:sec>\n \n RESULTS:<\/jats:title>\n After withdrawal, the number and proportion of estimated ED visits for CCM-related AEs involving children &lt;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: \u221215.4% [95% confidence interval [CI]: \u221225.9% to \u22125.0%]), whereas the overall number of estimated ED visits for CCM-related AEs for children &lt;12 years of age remained unchanged (9408 visits [95% CI: 6874\u201311 941 visits] vs 9727 visits [95% CI: 6649\u201312 805 visits]). During both periods, two-thirds of estimated ED visits involved unsupervised ingestions (ie, children finding and ingesting medications).<\/jats:p>\n <\/jats:sec>\n \n CONCLUSIONS:<\/jats:title>\n ED visits for CCM-related AEs among children &lt;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 &lt;4 years of age.<\/jats:p>\n <\/jats:sec>","DOI":"10.1542\/peds.2010-1839","type":"journal-article","created":{"date-parts":[[2010,11,23]],"date-time":"2010-11-23T04:48:04Z","timestamp":1290487684000},"page":"1100-1107","source":"Crossref","is-referenced-by-count":43,"title":["Adverse Events From Cough and Cold Medications After a Market Withdrawal of Products Labeled for Infants"],"prefix":"10.1542","volume":"126","author":[{"given":"Nadine","family":"Shehab","sequence":"first","affiliation":[{"name":"Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa K.","family":"Schaefer","sequence":"additional","affiliation":[{"name":"Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott R.","family":"Kegler","sequence":"additional","affiliation":[{"name":"Office of Statistics and Programming, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel S.","family":"Budnitz","sequence":"additional","affiliation":[{"name":"Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, and"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2010,12,1]]},"reference":[{"issue":"3","key":"2021121006591485600_B1","doi-asserted-by":"crossref","DOI":"10.1542\/peds.108.3.e52","article-title":"Toxicity of over-the-counter cough and cold medications","volume":"108","author":"Gunn","year":"2001","journal-title":"Pediatrics"},{"issue":"23","key":"2021121006591485600_B2","doi-asserted-by":"crossref","first-page":"2321","DOI":"10.1056\/NEJMp0707400","article-title":"Over the counter but no longer under the radar: pediatric cough and cold medications","volume":"357","author":"Sharfstein","year":"2007","journal-title":"N Engl J Med"},{"key":"2021121006591485600_B3","unstructured":"US Food and Drug Administration. Nonprescription Drug Advisory Committee Meeting: cold, 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. 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Makers of OTC cough and cold medicines announce voluntary withdrawal of oral infant medicines, October 11, 2007. Available at: www.chpa-info.org\/10_11_07_OralInfantMedicines.aspx. Accessed May 3, 2010"},{"key":"2021121006591485600_B11","unstructured":"US Food and Drug Administration. News & Events. FDA 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. Available at: www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/2008\/ucm116839.htm. 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Children's OTC cold medicines: the public, and parents, weigh in, December 2007. Available at: www.kff.org\/kaiserpolls\/upload\/7726.pdf. 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