Old Wine in New Bottles: Propranolol for Infantile Hemangioma

We are in the early stages of preparing an article on this subject, which has a fascinating back story. It begins with a letter to the editor of The New England Journal of Medicine in 2008, written by a group of physicians from a children’s hospital in Bordeaux, France. They were treating a 4-month-old infant with a large nasal hemangioma with corticosteroids, which stabilized the tumor, but the child developed obstructive hypertrophic myocardiopathy. Because of that complication, the patient was started on propranolol. The next day, the hemangioma had changed color from intense red to purple and was noticeably softer. The corticosteroids were stopped. After 10 months of propranolol treatment, the hemangioma was completely flat. The Bordeaux doctors then treated 10 more children with severe or disfiguring infantile hemangiomas with propranolol. In all 10, the color changed, the tumor softened, and the hemangiomas regressed until they were nearly flat, with residual skin telangiectasias.

That was a bombshell. Propranolol? There were no FDA-approved treatments for infantile hemangiomas, which tend to grow for a while and then regress on their own, but some can cause serious complications, including disfigurement, of course, but also obstruction of respiration or vision, bleeding, ulceration, and heart failure. Those were generally treated with corticosteroids, but interferon and cancer chemotherapy agents were also used. In the years since the report from Bordeaux, many case reports have been published describing the results of treating hemangiomas with oral propranolol (and a few with atenolol and topical propranolol). Almost all reported that the beta-blocker produced regression of the hemangioma with no side effects.

Concerns about the completeness of these reports and unanswered questions about long-term use of propranolol in infants, such as the optimal dose and duration, led to a consensus conference of US pediatricians and other specialists, which took place in December, 2011 and was published in Pediatrics, first online in December, 2012 and then in the journal in January, 2013. Propranolol was available in an oral suspension at that time, but not in a formulation suitable for dosing in infants. Now a French pharmaceutical manufacturer has received FDA approval for a product (Hemangeol) targeted specifically at this disorder and the age group in which it appears. Watch for our review.

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