{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T05:10:01Z","timestamp":1791609001624,"version":"4.3.4"},"reference-count":105,"publisher":"American Academy of Pediatrics (AAP)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2016,10,1]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND AND OBJECTIVES:<\/jats:title>\n                    <jats:p>Given the widespread use of propranolol in infantile hemangioma (IH) it was considered essential to perform a systematic review of its safety. The objectives of this review were to evaluate the safety profile of oral propranolol in the treatment of IH.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>We searched Embase and Medline databases (2007\u2013July 2014) and unpublished data from the manufacturer of Hemangiol\/Hemangeol (marketed pediatric formulation of oral propranolol; Pierre Fabre Dermatologie, Lavaur, France). Selected studies included \u226510 patients treated with oral propranolol for IH and that either reported \u22651 adverse event or effect (AE) or planned to capture AEs. Data capture was standardized and extracted study design, demographic characteristics, IH characteristics, intervention, and safety outcomes. AEs were assigned a system organ class and preferred term.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>A total of 83 of 398 identified literature records met the inclusion criteria, covering 3766 propranolol-treated patients. The manufacturer\u2019s data for 3 pooled clinical trials (435 propranolol-treated patients) and 1 Compassionate Use Program (1661 patients) were included. AE data were reported for 1945 of 5862 propranolol-treated patients. The most frequently reported AEs included a range of sleep disturbances, peripheral coldness, and agitation. The most serious AEs (atrioventricular block, bradycardia, hypotension, bronchospasm\/bronchial hyperreactivity, and hypoglycemia-related seizures) were managed by decreasing doses or temporary\/permanent discontinuation of propranolol. Limitations included the variety of included study designs; monitoring, collection, and reporting of AE data; small sample sizes for some articles; and the wide scope of review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>Oral propranolol is well tolerated if appropriate pretreatment assessments and within-treatment monitoring are performed to exclude patients with contraindications and to minimize serious side effects during treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1542\/peds.2016-0353","type":"journal-article","created":{"date-parts":[[2016,9,29]],"date-time":"2016-09-29T05:07:39Z","timestamp":1475125659000},"source":"Crossref","is-referenced-by-count":173,"title":["Safety of Oral Propranolol for the Treatment of Infantile Hemangioma: A Systematic Review"],"prefix":"10.1542","volume":"138","author":[{"given":"Christine","family":"L\u00e9aute-Labr\u00e8ze","sequence":"first","affiliation":[{"name":"Unit\u00e9 de Dermatologie P\u00e9diatrique et Centre d'Investigation Clinque P\u00e9diatrique 1401, H\u00f4pital Pellegrin-Enfants, Bordeaux, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Boccara","sequence":"additional","affiliation":[{"name":"Service de Dermatologie, H\u00f4pital Necker Enfants Malades, Paris, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Degrugillier-Chopinet","sequence":"additional","affiliation":[{"name":"Service Explorations Cardiovasculaires et de Cardiologie P\u00e9diatrique, Centre Hospitalier R\u00e9gional Universitaire de Lille, Lille, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juliette","family":"Mazereeuw-Hautier","sequence":"additional","affiliation":[{"name":"Service de Dermatologie et Centre de R\u00e9f\u00e9rence des Maladies Rares de la Peau, H\u00f4pital Larrey, Toulouse, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sorilla","family":"Prey","sequence":"additional","affiliation":[{"name":"Unit\u00e9 de Dermatologie P\u00e9diatrique et Centre d'Investigation Clinque P\u00e9diatrique 1401, H\u00f4pital Pellegrin-Enfants, Bordeaux, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Genevi\u00e8ve","family":"Lebb\u00e9","sequence":"additional","affiliation":[{"name":"Pierre Fabre Medicament, Boulogne, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phanie","family":"Gautier","sequence":"additional","affiliation":[{"name":"Institut de Recherche Pierre Fabre, Toulouse, France; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Val\u00e9rie","family":"Ortis","sequence":"additional","affiliation":[{"name":"Pierre Fabre Dermatologie, Lavaur, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martine","family":"Lafon","sequence":"additional","affiliation":[{"name":"Institut de Recherche Pierre Fabre, Toulouse, France; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agn\u00e8s","family":"Montagne","sequence":"additional","affiliation":[{"name":"Institut de Recherche Pierre Fabre, Toulouse, France; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Delarue","sequence":"additional","affiliation":[{"name":"Pierre Fabre Dermatologie, Lavaur, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Jacques","family":"Voisard","sequence":"additional","affiliation":[{"name":"Pierre Fabre Dermatologie, Lavaur, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2016,10,1]]},"reference":[{"issue":"2","key":"2021120904480621400_B1","doi-asserted-by":"crossref","first-page":"168","DOI":"10.1111\/j.1525-1470.2008.00626.x","article-title":"Infantile hemangiomas: how common are they? 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