The safety profile of oral propranolol seems to be good for children with infantile hemangioma, according to a study published online May 29 in Pediatrics

Catherine Droitcourt, M.D., from the University of Rennes in France, and colleagues used the French National Health Insurance system to perform a survey of a nationwide cohort of children aged <3 years with infantile hemangioma with at least one delivery of oral propranolol between July 2014 and June 2016.

hemangioma, also known as infantile hemangioma (IH), is one of the most common benign tumors of infancy and occurs in approximately 5–10% of infants, though it occurs past infancy on rare occasions. Infantile hemangiomas are benign vascular tumors composed of an increased number of unique endothelial cells that line blood vessels. They occur more frequently in female, premature and low birth weight infants.

A survey of a nationwide, claim-based observational cohort of children <3 years old, with at least one delivery of oral propranolol between July 2014 and June 2016, was performed by using the database of the French National Health Insurance system. Standardized morbidity ratios (SMRs) were calculated by using, from the same database, a representative random sample of nonexposed subjects.

Infantile hemangiomas usually appear within the first weeks of life and grow most rapidly during the first three to six months of life. For most hemangiomas, 80% of infantile hemangioma size is generally reached by 3 months of age. 

Usually, growth and proliferation are complete and involution commences by twelve months of age. However, involution occurs slowly over many years with a majority of infantile hemangioma regression occurring by five years of age.

Main Outcomes

The main outcomes were hospitalizations for cardiovascular (conduction disorders, bradycardia, and hypotension), respiratory (bronchial hyperactivity and bronchospasm), or metabolic events (hypoglycemia and hyperkalemia), identified through the hospitalization diagnostic codes of the International Classification of Diseases, 10th Revision.

The main analysis was conducted separately on “healthy” children (N = 1484), that is, free from of any prespecified underlying disease and on children with 1 of these underlying diseases (N = 269).

Standardized morbidity ratios (SMRs) were calculated using a representative sample of nonexposed children from the same database. The main analysis was conducted on 1,484 healthy children, free of any prespecified underlying disease and on 269 children with one underlying disease (cardiovascular, respiratory, or metabolic disease).

In patients with an underlying disease, usually congenital heart disease, there were 11 cardiovascular events (SMR, 6 [2.5 to 9.6]). Among children with the underlying disease, SMRs were not significantly elevated for respiratory or metabolic events.

"In this study on a large continuous nationwide claims database, we confirm the safety profile of oral propranolol in healthy children to be good," the authors write.