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

Abstract

BackgroundDespite 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.MethodsWe 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.ResultsA 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.ConclusionThe 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 .

Propranolol Treatment for Infantile Hemangiomas: Short-Term Adverse Effects and Follow-Up to Age Two

“…A study also showed that younger age, premature birth, and lower BW are associated with intolerable AEs [8]. On the contrary, starting age of younger than 5 weeks dose not lead to more AEs, compared with starting age of older than 5 months [35]. Our study showed that starting age of no older than 3 months led to more AEs in the CNS, and starting age of older than 3 months was a protective factor against side effects in the CNS.…”

Cardiac arrest in a toddler treated with propranolol for infantile Hemangioma: a case report

“…The number of patients treated with systemic beta-blockers for IHs is expected to grow and some clinicians might even consider offering this effective treatment to children beyond the proliferation phase. In fact off-label use of propranolol after 5 months of age (as for our case) has frequently been described as successful in the literature [ 14 – 17 ]. The experience with this drug is therefore accumulating and we will gain more and more information on its effectiveness [ 18 ] and its possible side effects.…”

A new clinical and dermoscopic monitoring of infantile hemangiomas treated with oral propranolol

“…12 Since then, three RTC and nine observational studies demonstrated a high safety profile of OP, [13][14][15][16][17][18][19][20] acceptable before 5 weeks and after 5 months of age. 21 OP is currently recommended as first-line treatment for proliferative phase IHs meeting the following criteria: 22 IHs causing/likely to cause visual impairment and potential or actual obstruction of the nasal cavity/airway/auditory canal, potential or actual functional impairment and/or lip deformities, IHs which develop ulceration or cause recurrent infection, organ compression (liver and spinal cord) and risk of permanent disfigurement.…”