Good safety profile for children with infantile hemangioma with no prespecified underlying disease
THURSDAY, May 31, 2018 (HealthDay News) — 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. 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).
The researchers found that two cardiovascular events, 51 respiratory events, and three metabolic events were observed in the healthy population (SMR, 2.8 [0 to 6.7], 1.7 [1.2 to 2.1], and 5.1 [0 to 10.9], respectively). 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 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.
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