Summary on Propranolol
Just finished reading 6 Abstracts on the use of Propranolol in the management of Infantile Hemangioma. All of the information came from presentations at the 2014 ISSVA meeting in Melbourne, Australia last week. A summary is below. Much of the information is just now being published in the latest Medical Journals so it truly is the latest medical information on the subject.
Propranolol is a widely prescribed medication classified as a beta-blocker used for the treatment of infantile hemangioma. Since 2007 it has been used off-label because there has not been an approved formulation of propranolol, specific for infants and the treatment of infantile hemangioma. Several institutions here in the USA and Europe have taken part in a 2+ year study assessing the safety of propranolol in infants. As a result an oral formulation will be available here in the USA in June 2014 under the brand name Hemangeol. (Pierre Fabre Pharmaceuticals USA will be manufacturing the medication) The studies have not only produced a new brand name of propranolol here in the USA but it has produced data on the safety and efficacy of this medication in the treatment of infantile hemangioma.
Oral Propranolol has a favorable risk profile in the pediatric population studied. In one study of 460 infants the IH improved in 88% of the patients treated with no unexpected safety concerns. This same group reported that patients tolerated the medication with mild or moderate side effects. The only contraindication being noted is bronchial reactivity. (1,2)
Another study examined the impact of propranolol on pediatric growth and human growth hormone levels in infants. No impact was found. (3)
A group from Russia studied the effects of propranolol on the cardiovascular system with and without preexisting heart problems. 154 infants with IH were prescribed propranolol and cardiological evaluation with EKG, ECHO, holter monitoring and blood pressure was observed for more then 9 months. Only a small percentage of adverse events were noted. This group recommends monitoring children at risk for cardiac complications during use of propranolol. A similar study out of Oregon concluded that routine ECG monitoring for patients prior to propranolol use is not necessary and a more purposed driven strategy is a better approach. (4,5)
272 Hemangioma Patients were evaluated for developmental psychomotor skills. No delays or effects on psychomotor development was found. (6)
In my review of this information propranolol appears to be safe to use in most infants and children presenting with infantile hemangioma. Patients should be monitored during treatment and physicians should be awear of the indications for concern. More studies are on going.
1.Christine Leaute-Labreze, Ilona Frieden, Pierre Vabres, Sorilla Prey, Jean-Jacques Voisard, Propranolol in IH: Results from an international randomized placebo controlled study.
2.Sorilla Prey, Christinen Leute-Labreze, Ilona Frieden, Allain Delarue, Jean Jacquez Voisard, Safety of oral propranolol for the treatment of IH: 2 years results of a controlled multicenter trial
3.Rachel Giese, Mario Cleves, Jessica Boswell, James Suen, Gresham Richter, Propranolol for Treatment of IH: Efficacy and Effect on Growth and Development
4. Margarita Timofeeva and Natalia Katlukova, Cardiovascular Complications of Propranolol Treatment for IH
5.Kevin Yarbrough, Alfan Krol, Julianne Mann, Sabra Leitenberger, Carol MacArthur, Is Routine ECG necessary prior to initiation of propranolol for treatment of IH
6. Andre Moyakine, Denise Hermans, Joris Fuijkschot, Carine van der Vleuten, Development Milestone: no negative effects detected upon psychomotor development
As these articles get published we will update the references and citations.