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Hemangeol found to be safe in treating infantile hemangioma
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Hemangeol was found to have a good overall safety profile as treatment for healthy children with infantile hemangioma, according to a study using a nationwide claims database in France.
“Infantile hemangioma (IH) is the most common soft tissue tumor in infants. Although the exact prevalence of IH remains unclear, it is estimated to affect 4% to 5% of white infants,” Catherine Droitcourt, MD, from the University of Rennes, and colleagues wrote.
“Although IH has a spontaneous course toward involution, treatment can be necessary to avoid or treat complications, which include painful, persistent ulcerations; compromised organ function; and disfiguring or life-threatening risks,” the researchers added.
Hemangeol (oral propranolol, Pierre Fabre Dermatologie) was approved by the FDA in 2014 for treating proliferating infantile hemangioma, requiring systemic treatment.
The European Medicines Agency (EMA) granted pediatric use marketing authorization (PUMA) to oral propranolol in April 2014 and included a risk management plan, which identified serious risks including cardiovascular, respiratory and metabolic disorders. The FDA issued similar warnings. In Europe, oral propranolol is marketed by Pierre Fabre Dermatologie under a slightly different product name, Hemangiol.
To assess the use of oral propranolol and its safety in real-world settings after the EMA granted the PUMA, Droitcourt and colleagues used the French National Health insurance database to conduct a nationwide, claims-based observational study of children aged at least 3 years with at least one delivery of oral propranolol from July 2014 to June 2016. ICD-10 codes were used to identify primary outcomes of hospitalization for cardiovascular events, including conduction disorders, bradycardia and hypotension; respiratory events, including bronchial hyperactivity and bronchospasms; or metabolic events, including hypoglycemia and hyperkalemia.
The analysis was conducted on 1,753 children (72.2% female; median age at oral propranolol initiation, 5 years) with at least two deliveries of oral propranolol. The patients were divided into two cohorts — 1,484 healthy children without any prespecified underlying disease and 269 children who had one of the diseases.
Two cardiovascular events (standardized morbidity ratio [SMR] = 2.8; 95% CI, 0-6.71), 51 respiratory events (SMR = 1.7; 95% CI, 1.2-2.1) and three metabolic events (SMR = 5.1; 95% CI, 0-10.9) were noted in the healthy cohort.
In 133 children with underlying cardiovascular diseases, 11 cardiovascular events for 1,025 person-months were noted during treatment (SMR = 6; 95% CI, 2.5-9.6). However, in the cohort with at least one underlying disease, SMRs for respiratory or metabolic events were not significantly higher.
“The data confirm the overall good safety profile of oral propranolol in children with IH, in particular for serious side effects with hospitalization,” the researchers concluded. “And the data show a stability of prescription levels for oral propranolol since the PUMA was granted. Our results do not support a reinforcement of oral propranolol monitoring in infants.” – by Bruce Thiel
Disclosures: The authors report no relevant financial disclosures.
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