Diagnosis and Management of Infantile Hemangioma

coldness (8%), agitation (8.5%), diarrhea (4.5%), somnolence (5.0%), nightmare (2.0%),
irritability (5.5%), decreased appetite (2.5%), and abdominal pain (3.5%). Adverse events and
frequencies for patients receiving Hemangeol® 3.4 mg/kg/day (n=224) included: sleep disorders
(16.1%), bronchitis (13.4%), peripheral coldness (6.7%), agitation (4.5%), diarrhea (6.3%),
somnolence (0.9%), nightmare (6.3%), irritability (1.3%), decreased appetite (3.6%), and
abdominal pain (0.4%). Additional adverse events reported in less than 1% of patients
participating in clinical trials included: second degree atrioventricular heart block (occurring in a
patient with underlying conduction disorder), urticaria, alopecia, decreased blood glucose, and
decreased heart rate.
The safety and efficacy of the oral tablet, oral capsule, and injectable formulations of
propranolol have not been investigated in pediatric patients. 207-209 The package inserts for these
formulations state that reports of bronchospasm and congestive heart failure have been reported
in pediatric patients receiving propranolol. Additional adverse events revealed during postmarketing
surveillance include agranulocytosis, hallucination, and purpura. 206
Harms of Other Active Comparator Agents
Harms of corticosteroids and PDL are presented in those sections; this section only includes
medications for which harms are not presented elsewhere in this review. In a study rated poor
quality for harms reporting, reported complications of bleomycin included febrile episode,
superficial ulceration, and raised alkaline phosphatase. 95 The proportion of participants who
experienced these complications is unclear. In another study, which was rated good quality for
harms reporting, adverse effects in 20 participants using imiquimod included crusting of lesions
(65%), superficial scars (15%), and skin pigmentation (29%).
Key Question 3. Effectiveness and Harms of Drugs
Administered After the Failure of Corticosteroids or Beta-
Blockers
We did not identify any comparative studies addressing this Key Question.
Key Question 4. Effectiveness and Harms of Surgical
Interventions
Key Points
• Studies primarily addressed different laser modalities compared with observation or other
laser modalities. PDL was the most commonly studied laser type, but multiple variations
in treatment protocols did not allow for demonstration of superiority of a single method
(low SOE for difference in effects on size reduction between longer pulse PDL and other
lasers).
• Two small studies addressed different surgical techniques (cryotherapy, intense pulsed
light photothermolysis, sclerosis) and reported some positive effects in reducing IH size
or improving appearance, but their smaller size and low quality preclude conclusions
(insufficient SOE).
• Many studies used historical controls, based on now superseded treatment regimens.
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