Prescribing Propranolol for Hemangioma of Infancy: Assessment of Dosing Errors

In 2008, oral propranolol was serendipitously discovered to be an effective treatment for Infantile hemangiomas (IH). Since then, this medication has gained widespread popular acceptance as a treatment for IH. Generic propranolol oral solution has been commercially available for decades in two different concentrations: 20 mg/5 mL and 40 mg/5 mL. These formulations have been widely used off-label since 2008, to treat IH, initially empirically dosed by weight, in gradually escalating amounts given every 8-12 hours, up to a total of 3 mg/kg/day. In 2014, a unique oral pediatric formulation (4.28 mg/mL propranolol hydrochloride, Hemangeol®, Pierre Fabre Pharmaceuticals Inc.), was approved by the United States Food and Drug Administration (FDA), and established as first-line therapy for high-risk IH. Access to Hemangeol® is via a single specialty pharmacy. Prior to Hemangeol® FDA approval, the lower concentration formulation of generic propranolol was used. However, multiple anecdotal reports have cited dispensing errors of...