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Diagnosis and Management of Infantile Hemangioma

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hypopigmentation, impaired wound healing, increased sweating, petechiae <strong>and</strong> ecchymoses,<br />

rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp<br />

hair, urticaria, abnormal fat deposits, decreased carbohydrate tolerance, development <strong>of</strong><br />

Cushingoid state, hirsutism, manifestations <strong>of</strong> latent diabetes mellitus <strong>and</strong> increased requirements<br />

for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon faces,<br />

secondary adrenocortical <strong>and</strong> pituitary unresponsiveness (particularly in times <strong>of</strong> stress, as in<br />

trauma, surgery or illness), suppression <strong>of</strong> growth in children, potassium loss, hypokalemic<br />

alkalosis, sodium retention, abdominal distention, elevation in serum liver enzymes levels<br />

(usually reversible upon discontinuation), hepatomegaly, hiccups, malaise, nausea, pancreatitis,<br />

peptic ulcer with possible perforation <strong>and</strong> hemorrhage, ulcerative esophagitis, osteonecrosis <strong>of</strong><br />

femoral <strong>and</strong> humeral heads, Charcot-like arthropathy, loss <strong>of</strong> muscle mass, muscle weakness,<br />

osteoporosis, pathologic fracture <strong>of</strong> long bones, steroid myopathy, tendon rupture, vertebral<br />

compression fractures, arachnoiditis, convulsions, depression, emotional instability, euphoria,<br />

headache, increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually<br />

following discontinuation <strong>of</strong> treatment, insomnia, meningitis, mood swings, neuritis, neuropathy,<br />

paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, vertigo,<br />

exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts,<br />

alteration in motility <strong>and</strong> number <strong>of</strong> spermatozoa.<br />

We also identified safety data for another steroid evaluated in studies in this review,<br />

mometasone furoate. The use <strong>of</strong> this medication in pediatric patients (>2 years) is not<br />

recommended for more than 3 weeks. 143 This medication is administered topically, <strong>and</strong> pediatric<br />

patients will have an increase in the skin surface area to body mass ratio. As a result, adverse<br />

events such as hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome, adrenal<br />

insufficiency upon cessation, skin atrophy, striae, linear growth retardation, delayed weight gain,<br />

<strong>and</strong> intracranial hypertension are more likely to occur in pediatric patients. We report additional<br />

harms data form package inserts <strong>and</strong> U.S. Food <strong>and</strong> Drug Administration (FDA) approval<br />

documents in Appendix H.<br />

Effectiveness <strong>and</strong> Harms <strong>of</strong> Beta-Blockers<br />

Key Points<br />

Propranolol Versus Observation or Placebo<br />

• In our network meta-analysis, oral propranolol was associated with a mean estimate <strong>of</strong><br />

expected clearance <strong>of</strong> IH <strong>of</strong> 95% (95% BCI: 88% to 99%) compared with 6 percent (95%<br />

BCI: 1% to 11%) for placebo or observation arms (high SOE for greater effectiveness <strong>of</strong><br />

propranolol versus placebo or observation).<br />

• Oral propranolol at doses <strong>of</strong> 2-3 mg/kg/day divided two to three times daily <strong>and</strong> given for<br />

up to 6 months promoted resolution or near resolution <strong>of</strong> IH in children under the age <strong>of</strong><br />

12 months with superficial, deep, mixed, or ulcerated IH in most studies.<br />

• Adverse events, measured in the short-term only, associated with these doses <strong>of</strong><br />

propranolol in this same population were limited in frequency <strong>and</strong> severity (moderate<br />

SOE association <strong>of</strong> propranolol with clinically important <strong>and</strong> minor harms).<br />

34

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