{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T02:01:22Z","timestamp":1790474482927,"version":"4.1.0"},"reference-count":21,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Quality and Outcomes"],"published-print":{"date-parts":[[2008,11]]},"abstract":"<jats:p>\n                    <jats:bold>\n                      <jats:italic>Background\u2014<\/jats:italic>\n                    <\/jats:bold>\n                    Many barriers exist to conducting pediatric cardiovascular (CV) trials, and the majority of therapies used are not evidence based. Recent legislation has aimed to stimulate pediatric research and improve drug labeling. This study describes off-label use of CV medications in children hospitalized with congenital and acquired CV disease.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>\n                      <jats:italic>Methods and Results\u2014<\/jats:italic>\n                    <\/jats:bold>\n                    The 2005 Pediatric Health Information System database was queried for patients with CV\n                    <jats:italic>International Classification of Disease, Ninth Revision<\/jats:italic>\n                    codes who received CV medications. Off-label use (patient younger than US Food and Drug Administration\u2013approved age) was described. Multivariate analysis used Poisson regression to model the number of CV drugs received off-label. There were 31 432 patients included (median age, 10.4 months; interquartile range, 30 days to 6.8 years). Congenital heart disease (67%) was the most common diagnosis. Other diagnoses included hypertension, arrhythmia, myocarditis\/cardiomyopathy, pulmonary hypertension, rheumatic fever\/endocarditis, and heart transplant. Seventy-eight percent received \u22651 CV medication off-label, and 31% received \u22653 CV medications off-label. The most commonly used CV medications were furosemide, epinephrine, dopamine, lidocaine, and milrinone. The latter 3 (prescribed in 69% of patients) were used off-label in all cases. Medications studied under recent federal initiatives were prescribed in only 20% of patients, and were still used off-label 62% of the time. In multivariate analysis, heart transplant recipients (odds ratio 1.7; 95% CI 1.5 to 1.9) were most likely to receive a greater number of off-label CV medications.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>\n                      <jats:italic>Conclusions\u2014<\/jats:italic>\n                    <\/jats:bold>\n                    Despite recent legislation, off-label use of CV medications in the pediatric population is common. These data highlight the need for further study to determine which treatments should be used more frequently and which are unsafe or ineffective in children hospitalized with CV disease.\n                  <\/jats:p>","DOI":"10.1161\/circoutcomes.108.787176","type":"journal-article","created":{"date-parts":[[2008,11,5]],"date-time":"2008-11-05T21:37:28Z","timestamp":1225921048000},"page":"74-83","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":73,"title":["Off-Label Use of Cardiovascular Medications in Children Hospitalized With Congenital and Acquired Heart Disease"],"prefix":"10.1161","volume":"1","author":[{"given":"Sara K.","family":"Pasquali","sequence":"first","affiliation":[{"name":"From the Division of Cardiology (S.K.P.), Department of Pediatrics, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC; Child Health Corporation of America (M.H.), Shawnee Mission, Kan; Departments of Pediatrics and Medicine (A.D.S.), Carilion Medical Center, Roanoke, Va; Department of Cardiology (K.J.J.), Children\u2019s Hospital, Boston, Mass; Divisions of Cardiology and Critical Care, Department of Pediatrics (B.S.M.), Cincinnati Children\u2019s Hospital Medical Center,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Hall","sequence":"additional","affiliation":[{"name":"From the Division of Cardiology (S.K.P.), Department of Pediatrics, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC; Child Health Corporation of America (M.H.), Shawnee Mission, Kan; Departments of Pediatrics and Medicine (A.D.S.), Carilion Medical Center, Roanoke, Va; Department of Cardiology (K.J.J.), Children\u2019s Hospital, Boston, Mass; Divisions of Cardiology and Critical Care, Department of Pediatrics (B.S.M.), Cincinnati Children\u2019s Hospital Medical Center,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony D.","family":"Slonim","sequence":"additional","affiliation":[{"name":"From the Division of Cardiology (S.K.P.), Department of Pediatrics, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC; Child Health Corporation of America (M.H.), Shawnee Mission, Kan; Departments of Pediatrics and Medicine (A.D.S.), Carilion Medical Center, Roanoke, Va; Department of Cardiology (K.J.J.), Children\u2019s Hospital, Boston, Mass; Divisions of Cardiology and Critical Care, Department of Pediatrics (B.S.M.), Cincinnati Children\u2019s Hospital Medical Center,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathy J.","family":"Jenkins","sequence":"additional","affiliation":[{"name":"From the Division of Cardiology (S.K.P.), Department of Pediatrics, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC; Child Health Corporation of America (M.H.), Shawnee Mission, Kan; Departments of Pediatrics and Medicine (A.D.S.), Carilion Medical Center, Roanoke, Va; Department of Cardiology (K.J.J.), Children\u2019s Hospital, Boston, Mass; Divisions of Cardiology and Critical Care, Department of Pediatrics (B.S.M.), Cincinnati Children\u2019s Hospital Medical Center,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley S.","family":"Marino","sequence":"additional","affiliation":[{"name":"From the Division of Cardiology (S.K.P.), Department of Pediatrics, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC; Child Health Corporation of America (M.H.), Shawnee Mission, Kan; Departments of Pediatrics and Medicine (A.D.S.), Carilion Medical Center, Roanoke, Va; Department of Cardiology (K.J.J.), Children\u2019s Hospital, Boston, Mass; Divisions of Cardiology and Critical Care, Department of Pediatrics (B.S.M.), Cincinnati Children\u2019s Hospital Medical Center,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meryl S.","family":"Cohen","sequence":"additional","affiliation":[{"name":"From the Division of Cardiology (S.K.P.), Department of Pediatrics, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC; Child Health Corporation of America (M.H.), Shawnee Mission, Kan; Departments of Pediatrics and Medicine (A.D.S.), Carilion Medical Center, Roanoke, Va; Department of Cardiology (K.J.J.), Children\u2019s Hospital, Boston, Mass; Divisions of Cardiology and Critical Care, Department of Pediatrics (B.S.M.), Cincinnati Children\u2019s Hospital Medical Center,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samir S.","family":"Shah","sequence":"additional","affiliation":[{"name":"From the Division of Cardiology (S.K.P.), Department of Pediatrics, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC; Child Health Corporation of America (M.H.), Shawnee Mission, Kan; Departments of Pediatrics and Medicine (A.D.S.), Carilion Medical Center, Roanoke, Va; Department of Cardiology (K.J.J.), Children\u2019s Hospital, Boston, Mass; Divisions of Cardiology and Critical Care, Department of Pediatrics (B.S.M.), Cincinnati Children\u2019s Hospital Medical Center,..."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_2_1_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.286.6.708"},{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1001\/archpedi.161.3.282"},{"key":"e_1_3_2_3_2","unstructured":"The Pediatric Exclusivity Provision January 2001 Status Report to Congress. 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Available at www.childrensoncologygroup.org. Accessed July 15 2007."},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-002-0479-9"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra035092"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1542\/peds.86.3.463"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-005-0981-y"},{"key":"e_1_3_2_19_2","unstructured":"List of Drugs for Which Pediatric Studies Are Needed: Federal Register notice 71FR23931 (issued 4\/25\/2006). Available at www.fda.gov\/cder\/pediatric. Accessed July 15 2007."},{"key":"e_1_3_2_20_2","unstructured":"Pediatric Heart Network current studies. Available at www.pediatricheartnetwork.org. 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