Christine Léaute-Labrèze1, Olivia Boccara2, Caroline Degrugillier-Chopinet3, Juliette Mazereeuw-Hautier4, Sorilla Prey5, Geneviève Lebbé6, Stéphanie Gautier7, Valérie Ortis8, Martine Lafon7, Agnès Montagne7, Alain Delarue8, Jean-Jacques Voisard8. 1. Unité de Dermatologie Pédiatrique et Centre d'Investigation Clinque Pédiatrique 1401, Hôpital Pellegrin-Enfants, Bordeaux, France; christine.labreze@chu-bordeaux.fr. 2. Service de Dermatologie, Hôpital Necker Enfants Malades, Paris, France. 3. Service Explorations Cardiovasculaires et de Cardiologie Pédiatrique, Centre Hospitalier Régional Universitaire de Lille, Lille, France. 4. Service de Dermatologie et Centre de Référence des Maladies Rares de la Peau, Hôpital Larrey, Toulouse, France. 5. Unité de Dermatologie Pédiatrique et Centre d'Investigation Clinque Pédiatrique 1401, Hôpital Pellegrin-Enfants, Bordeaux, France. 6. Pierre Fabre Medicament, Boulogne, France. 7. Institut de Recherche Pierre Fabre, Toulouse, France; and. 8. Pierre Fabre Dermatologie, Lavaur, France.
Abstract
BACKGROUND AND OBJECTIVES: 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. METHODS: We searched Embase and Medline databases (2007-July 2014) and unpublished data from the manufacturer of Hemangiol/Hemangeol (marketed pediatric formulation of oral propranolol; Pierre Fabre Dermatologie, Lavaur, France). Selected studies included ≥10 patients treated with oral propranolol for IH and that either reported ≥1 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. RESULTS: A total of 83 of 398 identified literature records met the inclusion criteria, covering 3766 propranolol-treated patients. The manufacturer's 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. CONCLUSIONS: 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.
BACKGROUND AND OBJECTIVES: 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. METHODS: We searched Embase and Medline databases (2007-July 2014) and unpublished data from the manufacturer of Hemangiol/Hemangeol (marketed pediatric formulation of oral propranolol; Pierre Fabre Dermatologie, Lavaur, France). Selected studies included ≥10 patients treated with oral propranolol for IH and that either reported ≥1 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. RESULTS: A total of 83 of 398 identified literature records met the inclusion criteria, covering 3766 propranolol-treated patients. The manufacturer's 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. CONCLUSIONS: 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.
Authors: Jillian G Baker; Christophe Fromont; Marjorie Bruder; Kevin S J Thompson; Barrie Kellam; Stephen J Hill; Sheila M Gardiner; Peter M Fischer Journal: ACS Pharmacol Transl Sci Date: 2020-07-01
Authors: Gerilyn M Olsen; Leanna M Hansen; Nicole S Stefanko; Erin Mathes; Katherine B Puttgen; Megha M Tollefson; Christine Lauren; Anthony J Mancini; Catherine C McCuaig; Ilona J Frieden; Denise Adams; Eulalia Baselga; Sarah Chamlin; Deepti Gupta; Peter Frommelt; Maria C Garzon; Kimberly Horii; Justyna Klajn; Mohit Maheshwari; Brandon Newell; Henry L Nguyen; Amy Nopper; Julie Powell; Dawn H Siegel; Beth A Drolet Journal: JAMA Dermatol Date: 2020-02-01 Impact factor: 10.282
Authors: Samuel L Brady; Ka Kit Wong; Mikhail Doubrovin; Yuanyuan Han; Yimei Li; Shengjie Wu; A K M Moinul Hossain; Charles B Chism; Mihir H Naik; Michael Rossi; Barry L Shulkin Journal: Mol Imaging Biol Date: 2020-10-16 Impact factor: 3.488
Authors: Samar R El Khoudary; Anthony Fabio; Jessie W Yester; Matthew L Steinhauser; Adam B Christopher; Frank Gyngard; Phillip S Adams; Victor O Morell; Melita Viegas; Jose P Da Silva; Luciana F Da Silva; Mario Castro-Medina; Andrew McCormick; Miguel Reyes-Múgica; Michelle Barlas; Honghai Liu; Dawn Thomas; Niyatie Ammanamanchi; Rachel Sada; Megan Cuda; Elizabeth Hartigan; David K Groscost; Bernhard Kühn Journal: Int J Cardiol Date: 2021-07-12 Impact factor: 4.164