Diagnosis and Management of Infantile Hemangioma

Harms of Beta-Blockers
Harms Reported in Studies Included in This Review
Thirteen comparative studies specifically defined harms of beta-blockers used to treat
IH. 17,92-94,98,101,102,104,105,132,133,144,145,147 Several studies specifically noted that no harms were
observed: one study evaluating topical timolol maleate 0.5 percent gel compared to placebo; 104 a
cohort study evaluating topical 0.25 percent timolol maleate gel; 144 one RCT of ophthalmic
timolol, 105 and a cohort study of timolol that informed parents of potential adverse effects to
monitor for, reported evaluating for safety (non-specified), and stated that no adverse effects
were reported. 103 An RCT comparing atenolol versus propranolol 102 and two other cohort studies
of intralesional propranolol 130 and up to 2mg/kg/day of oral propranolol 95 reported that no harms
were observed. Another RCT of propranolol (3-4 mg/kg/day) including 14 participants reported
asymptomatic hypotension and bradycardia in an unstated number of infants and discontinuation
of treatment in one child due to drowsiness. 99
One RCT comparing propranolol and prednisolone reported side effects associated with 2
mg/kg/day dosing of propranolol in the categories of allergy/immunology (0.02% of lesions),
dermatologic (0.05% of lesions), gastrointestinal (0.11% of lesions), infection (0.11% of
lesions), pulmonary/respiratory (0.32% of lesions), vascular (0.07% of lesions). 98 Fewer severe
adverse events occurred in the propranolol arm compared with prednisolone (1 vs. 11, p=0.01);
the one severe event in the propranolol arm was a case of dehydration necessitating
hospitalization. Children in the propranolol group had more pulmonary events (typically upper
respiratory tract infections) than those in the prednisolone arm (14 vs. 5, p