{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T06:16:26Z","timestamp":1792131386485,"version":"4.4.0"},"reference-count":18,"publisher":"American Academy of Pediatrics (AAP)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,6,1]]},"abstract":"<jats:sec>\n                    <jats:title>OBJECTIVES:<\/jats:title>\n                    <jats:p>The safety of oral propranolol for infantile hemangioma has not yet been studied at population level since the pediatric use marketing authorization was obtained in Europe.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>A survey of a nationwide, claim-based observational cohort of children &amp;lt;3 years old, with at least 1 delivery of oral propranolol between July 2014 and June 2016, was performed by using the database of the French National Health Insurance system. Standardized morbidity ratios (SMRs) were calculated by using, from the same database, a representative random sample of nonexposed subjects. The main outcomes were hospitalizations for cardiovascular (conduction disorders, bradycardia, and hypotension), respiratory (bronchial hyperactivity and bronchospasm), or metabolic events (hypoglycemia and hyperkalaemia), identified through the hospitalization diagnostic codes of the International Classification of Diseases, 10th Revision. The main analysis was conducted separately on \u201chealthy\u201d children (N = 1484), that is, free from of any prespecified underlying disease and on children with 1 of these underlying diseases (N = 269).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>In all, 1753 patients &amp;lt;3 years of age had at least 2 deliveries of oral propranolol. In the healthy population, we observed 2 cardiovascular events (SMR = 2.8 [0\u20136.7]), 51 respiratory events (SMR = 1.7 [1.2\u20132.1]), and 3 metabolic events (SMR = 5.1 [0\u201310.9]). In the population with an underlying disease (mainly congenital heart disease), we observed 11 cardiovascular events leading to an SMR of 6.0 (2.5\u20139.6). SMRs were not significantly raised for respiratory or metabolic events in this \u201cnonhealthy\u201d population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>In this study on a large continuous nationwide claims database, we confirm the safety profile of oral propranolol in healthy children to be good.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1542\/peds.2017-3783","type":"journal-article","created":{"date-parts":[[2018,5,29]],"date-time":"2018-05-29T03:35:10Z","timestamp":1527564910000},"source":"Crossref","is-referenced-by-count":46,"title":["Safety of Oral Propranolol for Infantile Hemangioma"],"prefix":"10.1542","volume":"141","author":[{"given":"Catherine","family":"Droitcourt","sequence":"first","affiliation":[{"name":"University of Rennes, Rennes, France;"},{"name":"Departments of Dermatology,"},{"name":"Institut National de la Sant\u00e9 et de la Recherche M\u00e9dicale, Centre d'Investigation Clinique 1414, Rennes, France;"},{"name":"University of Rennes, EA 7449 REPERES Pharmacoepidemiology and Health Services Research, Rennes, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandrine","family":"Kerbrat","sequence":"additional","affiliation":[{"name":"University of Rennes, EA 7449 REPERES Pharmacoepidemiology and Health Services Research, Rennes, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Rault","sequence":"additional","affiliation":[{"name":"University of Rennes, EA 7449 REPERES Pharmacoepidemiology and Health Services Research, Rennes, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie-Anne","family":"Botrel","sequence":"additional","affiliation":[{"name":"University of Rennes, EA 7449 REPERES Pharmacoepidemiology and Health Services Research, Rennes, 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