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Since 2014, propranolol has been approved in both Europe and the U.S. for treatment of infantile hemangioma. Early safety studies were reassuring, but postmarketing, large-scale observational data from real-life settings have not been reported.
Using nationwide claims data, researchers in France assessed risks for respiratory, cardiovascular, and metabolic health events requiring hospitalization among 1753 children aged <3 years who received at least two doses of propranolol between 2014 and 2016. Standardized morbidity ratios (SMR) were calculated, comparing the number of observed events in propranolol-exposed children with the number of expected events (based on a matched population of nonexposed children). Children with underlying cardiov…