Journal Article

Safety and effectiveness of oral propranolol for infantile hemangiomas started before 5 weeks and after 5 months of age: an Italian multicenter experience

Dalmonte, Pietro, Boccaletti, Valeria, Gesualdo, Francesco, Cutrone, Mario, Carnevale, Claudia, Neri, Iria, Porcedda, Giulio, El Hachem, Maya, Oranges, Teresa, Vercellino, Nadia, Berti, Irene, Diociaiuti, Andrea, Greco, Antonella

2017

Overview

Background Despite not being licensed for the treatment of infantile hemangiomas (IH) in infants younger than 5 weeks or older than 5 months, propranolol is often used in these age groups to prevent or to treat potentially severe complications. The objective of the present study was to review the experience of 8 Italian pediatric and dermatologic centers regarding propranolol treatment for IH started before 5 weeks or after 5 months of age. Methods We retrospectively reviewed the records of patients followed up for IH, on propranolol treatment started before 5 weeks or after 5 months of age, and collected information on sociodemographic data, treatment indications, IH involution, IH relapse, and treatment side effects. Results A total of 343 patients were enrolled; 15 were started on propranolol before 5 weeks (group 1), 328 were started after 5 months of age (group 2). The most frequent indications were permanent aesthetical disfigurement (91.8%) and function threatening complications (42.6%). In most cases, the treatment was effective. The involution was partial in 67.7% of patients. In 11.8% of cases a relapse was observed. No relapse was observed in group 1. Treatment complications were reported in 15.8% of children, most frequently sleep disorders (6.6%), followed by irritability (5.1%) and diarrhea (2.2%). Only a case of mild constipation was observed in group 1. Conclusion The safety and effectiveness profile of propranolol in infants younger than 5 weeks or older than 5 months may be acceptable. Taking in account propranolol's potential in preventing severe complications, further studies should assess the acceptability of propranolol treatment, especially in the <5-week age group .

• Publisher: BioMed Central,Springer Nature B.V,BMC
• Subject: Administration, Oral / Age / Age Factors / Amblyopia / Amniocentesis / Cardiac arrhythmia / Cohort Studies / Deformities / Dose-Response Relationship, Drug / Drug Administration Schedule / Female / Hemangioma - diagnosis / Hemangioma - drug therapy / Humans / Hypoglycemia / Infant / Infant, Newborn / Italy / Male / Maternal and Child Health / Medicine / Medicine & Public Health / Patient Safety / Patients / Pediatrics / Preeclampsia / Propranolol / Propranolol - administration & dosage / Propranolol - adverse effects / Retrospective Studies / Skin Neoplasms - diagnosis / Skin Neoplasms - drug therapy / Sleep Disorder / Sociodemographics / Statistical analysis / Treatment Outcome / Treatment Start / Twin Pregnancy