{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T00:50:56Z","timestamp":1761094256573,"version":"build-2065373602"},"reference-count":12,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2013,1,10]],"date-time":"2013-01-10T00:00:00Z","timestamp":1357776000000},"content-version":"vor","delay-in-days":9,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2013,1]]},"abstract":"<jats:sec><jats:title>Study Objective<\/jats:title><jats:p>To augment the December 2010 United States Food and Drug Administration (<jats:styled-content style=\"fixed-case\">FDA<\/jats:styled-content>) Drug Safety Communication on accidental ingestion of benzonatate in children less than 10\u00a0years old by summarizing data on emergency department visits, benzonatate exposure, and reports of benzonatate overdoses from several data sources.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Retrospective review of adverse\u2010event reports and drug utilization data of benzonatate.<\/jats:p><\/jats:sec><jats:sec><jats:title>Data Sources<\/jats:title><jats:p>The <jats:styled-content style=\"fixed-case\">FDA<\/jats:styled-content> Adverse Event Reporting System (<jats:styled-content style=\"fixed-case\">AERS<\/jats:styled-content>) database (1969\u20132010), the National Electronic Injury Surveillance System\u2014Cooperative Adverse Drug Event Surveillance Project (<jats:styled-content style=\"fixed-case\">NEISS<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">CADES<\/jats:styled-content>, 2004\u20132009), and the <jats:styled-content style=\"fixed-case\">IMS<\/jats:styled-content> commercial data vendor (2004\u20132009).<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients<\/jats:title><jats:p>Any patient who reported an adverse event with benzonatate captured in the <jats:styled-content style=\"fixed-case\">AERS<\/jats:styled-content> or <jats:styled-content style=\"fixed-case\">NEISS<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">CADES<\/jats:styled-content> database or received a prescription for benzonatate according to the <jats:styled-content style=\"fixed-case\">IMS<\/jats:styled-content> commercial data vendor.<\/jats:p><\/jats:sec><jats:sec><jats:title>Measurements and Main Results<\/jats:title><jats:p>Postmarketing adverse events with benzonatate were collected from the <jats:styled-content style=\"fixed-case\">AERS<\/jats:styled-content> database, emergency department visits due to adverse events with benzonatate were collected from the <jats:styled-content style=\"fixed-case\">NEISS<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">CADES<\/jats:styled-content> database, and outpatient drug utilization data were collected from the <jats:styled-content style=\"fixed-case\">IMS<\/jats:styled-content> commercial data vendor. Of 31 overdose cases involving benzonatate reported in the <jats:styled-content style=\"fixed-case\">AERS<\/jats:styled-content> database, 20 had a fatal outcome, and five of these fatalities occurred from accidental ingestions in children 2 years of age and younger. The <jats:styled-content style=\"fixed-case\">NEISS<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">CADES<\/jats:styled-content> database captured emergency department visits involving 12 cases of overdose from accidental benzonatate ingestions in children aged 1\u20133\u00a0years. Signs and symptoms of overdose included seizures, cardiac arrest, coma, brain edema or anoxic encephalopathy, apnea, tachycardia, and respiratory arrest and occurred in some patients within 15\u00a0minutes of ingestion. Dispensed benzonatate prescriptions increased by approximately 52% from 2004 to 2009.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Although benzonatate has a long history of safe use, accumulating cases of fatal overdose, especially in children, prompted the <jats:styled-content style=\"fixed-case\">FDA<\/jats:styled-content> to notify health care professionals about the risks of benzonatate overdose. Pharmacists may have a role in preventing benzonatate overdoses by counseling patients on signs and symptoms of benzonatate overdose, the need for immediate medical care, and safe storage and disposal of benzonatate.<\/jats:p><\/jats:sec>","DOI":"10.1002\/phar.1153","type":"journal-article","created":{"date-parts":[[2013,1,10]],"date-time":"2013-01-10T08:47:27Z","timestamp":1357807647000},"page":"38-43","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Analysis of Benzonatate Overdoses Among Adults and Children from 1969\u20132010 by the United States Food and Drug Administration"],"prefix":"10.1002","volume":"33","author":[{"given":"Melinda W.","family":"McLawhorn","sequence":"first","affiliation":[{"name":"Division of Pharmacovigilance\u2010I Office of Pharmacovigilance and Epidemiology Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margie R.","family":"Goulding","sequence":"additional","affiliation":[{"name":"Division of Epidemiology\u2010II Office of Pharmacovigilance and Epidemiology Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajdeep K.","family":"Gill","sequence":"additional","affiliation":[{"name":"Division of Epidemiology\u2010II Office of Pharmacovigilance and Epidemiology Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theresa M.","family":"Michele","sequence":"additional","affiliation":[{"name":"Division of Pulmonary, Allergy, and Rheumatology Products Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,1,10]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tips.2004.09.009"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.99.6.918"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1378\/chest.129.1_suppl.222S"},{"key":"e_1_2_7_5_1","unstructured":"Pfizer Inc.Tessalon (benzonatate) package insert. 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