Diagnosis and Management of Infantile Hemangioma

Table 8. Harms/adverse effects in comparative studies of steroids to treat IH (continued)
N Studies Reporting
Intervention
Harm/Adverse Event
Harm (# Participants
With Harm/Total
Participants)
Prednisone 2-2.8
mg/kg/day
IV methylprednisolone
30mg/kg
Intralesional
triamcinolone with or
without other steroids 1-
5 mg/kg
Oral corticosteroids
(undefined)
Irritability or behavioral
changes 96,132,133
Reported Rates
Across Studies
2 (8/50) 6%-17%
Oral thrush 96 1 (2/12) 17%
Insomnia 96 1 (1/12) 8%
Hypertension 96,132,133 2 (3/50) 5%-8%
Growth failure 96,132,133 2 (4/50) 3%-8%
Cushingoid appearance 132,133 1 (38/38) 100%
Glucosuria 132,133 1 (1/38) 3%
Irritability 107 1 (3/10) 30%
Crying 107 1 (2/10) 20%
Hyperactivity 107 1 (2/10) 20%
Vomiting 107 1 (2/10) 20%
Abdominal pain 107 1 (2/10) 20%
Insomnia 107 1 (1/10) 10%
Apathy 107 1 (1/10) 10%
Behavioral change 107 1 (1/10) 10%
Respiratory distress 107 1 (1/10) 10%
Pain 122 1 (47/47) 100%
Itching 122 1 (9/47) 19.1%
Bleeding 122,131 2 (17/76) 17%-31%
Infection 122 1 (8/47) 17%
Ulceration 108,131 2 (8/54) 4%-24%
Ulcer and depigmentation 108 1 (1/25) 4%
Cushingoid appearance 122 1 (1/47) 2.1%
Skin atrophy 108,122 2 (5/72) 4%-8.5%
Skin depigmentation or
2 (6/72) 6.4%-12%
hypopigmentation 108,122
Cushingoid appearance 97 1 (42/42) 100%
Gastroesophageal reflux 97 1 (4/42) 10%
Arterial bleed 97 1 (4/42) 10%
Hirsutism 97 1 (4/42) 10%
Growth retardation 97 1 (4/42) 10%
Hypercholesterolemia 97 1 (4/42) 10%
Scarring and lip contraction 97 1 (4/42) 10%
Hypertension 97 1 (2/42) 5%
Mometasone furoate Itching 122 1 (10/52) 19.2%
(topical)
Hypopigmentation 122 1 (4/52) 7.7%
Observation Spontaneous ulceration 108 1 (4/25) 16%
IH = infantile hemangioma; n = number
Note: One study 40 comparing prednisolone and methylprednisolone regimens reported Cushingoid facies in 20/45 children,
irritability in 16/45, and increased appetite in “almost all” children. The study does not report the regimen associated with each
adverse event. One cohort study comparing propranolol and prednisone was reported in 2 publications. 132,133 we use the harms
data reported in the 2008 publication. 133
Case series included 3508 children receiving intralesional, oral, or topical steroids or
combinations of agents, with doses of oral steroids ranging from 1 to 5 mg/kg/day and
intralesional doses (where reported) ranged from 0.5 to 6 ml (Table 9). We considered all studies
as poor quality for harms reporting. No studies explicitly reported harms sought, and the lack of
a comparison group and typically small sample sizes limit our understanding of the significance
of these harms.
Frequently reported harms across agents were Cushingoid facies (reported in 0.45%-100%
of children in 12 studies), diminished height or weight gain or growth retardation (0.45%-47% of
31