Nancy Bauman, MD, a pediatric otolaryngologist at Children’s National Medical Center in Washington, D.C., who is among those calling for more evidence, particularly prospective evidence, cites past experience with a drug that everyone thought was safe but that, over time, was shown to be unsafe in infants with hemangiomas.
Explore This IssueJuly 2011
“Years ago, we were excited about the use of alpha-interferon for treatment of infantile hemangiomas, but several years later our enthusiasm was dampened by its association with spastic diplegia when given to young infants,” she said.
Dr. Bauman thinks that propranolol is an excellent medication for infantile hemangiomas and believes that it is safe but feels that adverse events need to be carefully collected and monitored. “The increasing use of propranolol for treating infantile hemangiomas without first completing phase 2 studies is the natural process of using any medication [that is] available on the market but [is] used for an off-label indication,” she said.
To that end, she and colleagues recently conducted a literature review of all 49 manuscripts published on this topic before September 2010. The review is in press for the Annals of Otology, Rhinology and Laryngology and highlights not only the efficacy of propranolol, but also the importance of monitoring and tracking the side effects that occur in 17 percent of patients and can be serious, such as bradycardia, hypotension, hypoglycemia and bronchospasm.
Currently, data from non-prospective studies indicate that propranolol is well tolerated with few frequent side effects. Minor side effects like sleepiness and gastroesophageal reflux made up much of the toxicity reported in the most recently published series of studies by investigators from the University of Arkansas (Laryngoscope. 2010;120(4):676-681). Among the 32 children treated with oral propranolol in that study, 10 had minor side effects, of which somnolence was the most frequent (27.2 percent), followed by gastroesophageal reflux (9.1 percent), respiratory syncytial virus exacerbation (4.5 percent) and rash (4.5 percent).
Although none of the children in the study experienced serious side effects, and hemangiomas improved in 97 percent of participants, with 50 percent achieving an excellent response, lead author Lisa Buckmiller, MD, emphasized that propranolol should not be used lightly in this setting.
“Propranolol is a great medication in our armamentarium for treating hemangiomas,” Dr. Buckmiller said, but she emphasized that “serious side effects like life-threatening bronchospasm and hypoglycemia can occur, and we are discovering more about the medication and its side effects every day.”