{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T13:38:45Z","timestamp":1784209125474,"version":"3.55.0"},"reference-count":25,"publisher":"American Academy of Pediatrics (AAP)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,6,1]]},"abstract":"<jats:sec>\n                  <jats:title>BACKGROUND AND OBJECTIVES:<\/jats:title>\n                  <jats:p>The safety of cough and cold medication (CCM) use in children has been questioned. We describe the safety profile of CCMs in children &amp;lt;12 years of age from a multisystem surveillance program.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>METHODS:<\/jats:title>\n                  <jats:p>Cases with adverse events (AEs) after ingestion of at least 1 index CCM ingredient (brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, and pseudoephedrine) in children &amp;lt;12 years of age were collected from 5 data sources. An expert panel determined relatedness, dose, intent, and risk factors. Case characteristics and AEs are described.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS:<\/jats:title>\n                  <jats:p>Of the 4202 cases reviewed, 3251 (77.4%) were determined to be at least potentially related to a CCM, with accidental unsupervised ingestions (67.1%) and medication errors (13.0%) the most common exposure types. Liquid (67.3%), pediatric (75.5%), and single-ingredient (77.5%) formulations were most commonly involved. AEs occurring in &amp;gt;20% of all cases included tachycardia, somnolence, hallucinations, ataxia, mydriasis, and agitation. Twenty cases (0.6%) resulted in death; most were in children &amp;lt;2 years of age (70.0%) and none involved a therapeutic dose. The overall reported AE rate was 0.573 cases per 1 million units (ie, tablets, gelatin capsules, or liquid equivalent) sold (95% confidence interval, 0.553\u20130.593) or 1 case per 1.75 million units.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS:<\/jats:title>\n                  <jats:p>The rate of AEs associated with CCMs in children was low. Fatalities occurred even less frequently. No fatality involved a therapeutic dose. Accidental unsupervised ingestions were the most common exposure types and single-ingredient, pediatric liquid formulations were the most commonly reported products. These characteristics present an opportunity for targeted prevention efforts.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1542\/peds.2016-3070","type":"journal-article","created":{"date-parts":[[2017,5,4]],"date-time":"2017-05-04T09:10:14Z","timestamp":1493889014000},"source":"Crossref","is-referenced-by-count":34,"title":["Safety Profile of Cough and Cold Medication Use in Pediatrics"],"prefix":"10.1542","volume":"139","author":[{"given":"Jody L.","family":"Green","sequence":"first","affiliation":[{"name":"Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George Sam","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Children\u2019s Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, Colorado;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate M.","family":"Reynolds","sequence":"additional","affiliation":[{"name":"Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Banner","sequence":"additional","affiliation":[{"name":"Oklahoma Center for Poison and Drug Information, Oklahoma University College of Pharmacy, Oklahoma City, Oklahoma;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G. Randall","family":"Bond","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Hope Africa University, Bujumbura, Burundi;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralph E.","family":"Kauffman","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert B.","family":"Palmer","sequence":"additional","affiliation":[{"name":"Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian M.","family":"Paul","sequence":"additional","affiliation":[{"name":"Departments of Pediatrics and"},{"name":"Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard C.","family":"Dart","sequence":"additional","affiliation":[{"name":"Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2017,6,1]]},"reference":[{"key":"2021121100490801900_B1","unstructured":"US Food and Drug Administration\n          . Joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee. Briefing information. Available at: https:\/\/www.fda.gov\/ohrms\/dockets\/ac\/07\/briefing\/2007-4323b1-00-index.htm. Accessed December 9, 2016"},{"key":"2021121100490801900_B2","unstructured":"Testimony of David Bromberg, MD, FAAP, on behalf of the American Academy of Pediatrics. Available at: https:\/\/www.aap.org\/en-us\/advocacy-and-policy\/federal-advocacy\/Documents\/David_Bromberg_Testimony_11-17-11.pdf. Accessed December 12, 2016"},{"key":"2021121100490801900_B3","author":"Berkelhamer"},{"issue":"2","key":"2021121100490801900_B4","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2008-0498","article-title":"Cough and cold medication use by US children, 1999-2006: results from the slone survey.","volume":"122","author":"Vernacchio","year":"2008","journal-title":"Pediatrics"},{"issue":"1","key":"2021121100490801900_B5","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1016\/j.acap.2009.07.002","article-title":"Physician and parent response to the FDA advisory about use of over-the-counter cough and cold medications.","volume":"10","author":"Garbutt","year":"2010","journal-title":"Acad Pediatr"},{"issue":"11","key":"2021121100490801900_B6","doi-asserted-by":"crossref","first-page":"1083","DOI":"10.1177\/0009922813497427","article-title":"Cold preparation use in young children.","volume":"52","author":"Lazarus","year":"2013","journal-title":"Clin Pediatr (Phila)"},{"issue":"5","key":"2021121100490801900_B7","doi-asserted-by":"crossref","first-page":"1024","DOI":"10.1016\/j.jpeds.2014.07.047","article-title":"The impact of pediatric labeling changes on prescribing patterns of cough and cold medications.","volume":"165","author":"Mazer-Amirshahi","year":"2014","journal-title":"J Pediatr"},{"issue":"6","key":"2021121100490801900_B8","doi-asserted-by":"crossref","first-page":"1047","DOI":"10.1542\/peds.2013-2236","article-title":"Cough and cold medication adverse events after market withdrawal and labeling revision.","volume":"132","author":"Hampton","year":"2013","journal-title":"Pediatrics"},{"issue":"6","key":"2021121100490801900_B9","doi-asserted-by":"crossref","first-page":"510","DOI":"10.1097\/PEC.0b013e3182587b0c","article-title":"Effect of cough and cold medication withdrawal and warning on ingestions by young children reported to Texas poison centers.","volume":"28","author":"Forrester","year":"2012","journal-title":"Pediatr Emerg Care"},{"key":"2021121100490801900_B10","unstructured":"International Conference on Harmonisation\n          . ICH harmonised tripartitie guideline: clinical safety data management: definitions and standards for expedited reporting. Available at: www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E2A\/Step4\/E2A_Guideline.pdf. Accessed June 1, 2016"},{"key":"2021121100490801900_B11","first-page":"30042","article-title":"Cough, cold, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for OTC antitussive drug products.","volume":"52","author":"Food and Drug Administration","year":"1987","journal-title":"Fed Regist"},{"key":"2021121100490801900_B12","first-page":"29172","article-title":"Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for OTC antitussive drug products.","volume":"59","author":"Food and Drug Administration","year":"1994","journal-title":"Fed Regist"},{"key":"2021121100490801900_B13","first-page":"4216","article-title":"Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for OTC antihistamine drug products.","volume":"59","author":"Food and Drug Administration","year":"1994","journal-title":"Fed Regist"},{"key":"2021121100490801900_B14","first-page":"58356","article-title":"Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for OTC antihistamine drug products.","volume":"57","author":"Food and Drug Administration","year":"1992","journal-title":"Fed Regist"},{"key":"2021121100490801900_B15","first-page":"8494","article-title":"Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; expectorant drug products for over-the-counter human use; final monograph.","volume":"54","author":"Food and Drug Administration","year":"1989","journal-title":"Fed Regist"},{"key":"2021121100490801900_B16","first-page":"43386","article-title":"Cold, cough allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for OTC nasal decongestant drug products.","volume":"59","author":"Food and Drug Administration","year":"1994","journal-title":"Fed Regist"},{"issue":"9","key":"2021121100490801900_B17","doi-asserted-by":"crossref","first-page":"1508","DOI":"10.1016\/S0149-2918(04)80297-2","article-title":"Dose-response relationship with increasing doses of dextromethorphan for children with cough.","volume":"26","author":"Paul","year":"2004","journal-title":"Clin Ther"},{"issue":"4","key":"2021121100490801900_B18","doi-asserted-by":"crossref","first-page":"411","DOI":"10.1016\/j.annemergmed.2008.09.015","article-title":"Pediatric fatalities associated with over the counter (nonprescription) cough and cold medications.","volume":"53","author":"Dart","year":"2009","journal-title":"Ann Emerg Med"},{"issue":"11","key":"2021121100490801900_B19","first-page":"CD001831","article-title":"Over-the-counter (OTC) medications for acute cough in children and adults in community settings.","author":"Smith","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"issue":"5","key":"2021121100490801900_B20","doi-asserted-by":"crossref","first-page":"1372","DOI":"10.1016\/j.jpeds.2013.04.054","article-title":"Effect of cough and cold medication restriction and label changes on pediatric ingestions reported to United States poison centers.","volume":"163","author":"Mazer-Amirshahi","year":"2013","journal-title":"J Pediatr"},{"issue":"4","key":"2021121100490801900_B21","doi-asserted-by":"crossref","first-page":"1134","DOI":"10.1016\/j.jpeds.2013.05.045","article-title":"Efficacy of flow restrictors in limiting access of liquid medications by young children.","volume":"163","author":"Lovegrove","year":"2013","journal-title":"J Pediatr"},{"issue":"149","key":"2021121100490801900_B22","first-page":"40111","article-title":"Child-resistant packaging for certain over-the-counter drug products. Final rule.","volume":"66","author":"Consumer Product Safety Commission","year":"2001","journal-title":"Fed Regist"},{"key":"2021121100490801900_B23","first-page":"641","article-title":"Do new child resistant closures reduce injury following accidental ingestion?","volume":"53","author":"Geller","year":"2015","journal-title":"Clin Toxicol"},{"issue":"2","key":"2021121100490801900_B24","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2014-0395","article-title":"Unit of measurement used and parent medication dosing errors.","volume":"134","author":"Yin","year":"2014","journal-title":"Pediatrics"},{"issue":"2","key":"2021121100490801900_B25","doi-asserted-by":"crossref","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","article-title":"Research electronic data capture (REDCap)\u2013a metadata-driven methodology and workflow process for providing translational research informatics support.","volume":"42","author":"Harris","year":"2009","journal-title":"J Biomed Inform"}],"container-title":["Pediatrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/doi\/10.1542\/peds.2016-3070\/1063154\/peds_20163070.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/doi\/10.1542\/peds.2016-3070\/1063154\/peds_20163070.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,11]],"date-time":"2021-12-11T08:23:41Z","timestamp":1639211021000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.aap.org\/pediatrics\/article\/139\/6\/e20163070\/38712\/Safety-Profile-of-Cough-and-Cold-Medication-Use-in"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,6,1]]},"references-count":25,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2017,6,1]]},"published-print":{"date-parts":[[2017,6,1]]}},"URL":"https:\/\/doi.org\/10.1542\/peds.2016-3070","relation":{},"ISSN":["0031-4005","1098-4275"],"issn-type":[{"value":"0031-4005","type":"print"},{"value":"1098-4275","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,6,1]]},"article-number":"e20163070"}}