Safety of oral propranolol for infantile hemangioma

Although European regulators have granted pediatric use marketing approval to oral propranolol for the treatment of infantile hemangioma, the drug's safety had not been assessed at population level.

Although European regulators have granted pediatric use marketing approval to oral propranolol for the treatment of infantile hemangioma, the drug's safety had not been assessed at population level. A team of French researchers undertook the task, using a nationwide claims database to identify children aged 3 years or younger who had been given propranolol at any time during July 2014–June 2016. They counted 1,753 patients—1,484 of whom were healthy, with no underlying disease, and 269 of whom suffered from cardiovascular (CV), respiratory, or metabolic disease. There were 2 CV events requiring hospitalization in the healthy population vs. 11 in the "unhealthy" group, verifying the acceptable safety profile for oral propranolol. The number of respiratory and metabolic events in the healthy children was also considered favorable.