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

Ital J Pediatr. 2017 Apr 19;43(1):40. doi: 10.1186/s13052-017-0357-9.

Abstract

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 .

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Administration, Oral
  • Age Factors
  • Cohort Studies
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Hemangioma / diagnosis
  • Hemangioma / drug therapy*
  • Humans
  • Infant
  • Infant, Newborn
  • Italy
  • Male
  • Patient Safety
  • Propranolol / administration & dosage*
  • Propranolol / adverse effects
  • Retrospective Studies
  • Skin Neoplasms / diagnosis
  • Skin Neoplasms / drug therapy*
  • Treatment Outcome

Substances

  • Propranolol