COMMENTARY

Bradycardia, Hypotension, and Hypoglycemia: Is Propranolol Safe for Infants?

William T. Basco, Jr, MD, MS

Disclosures

September 18, 2018

Infantile hemangioma is relatively common.[1] These benign vascular neoplasms generally appear after birth and increase in size during the first 6 months of life, stabilize in size at age 12-18 months, and then begin to involute.[1] In the later 2000s, infants began to be treated with propranolol for infantile hemangioma; however, potential side effects, including bradycardia, hypotension, and hypoglycemia, raised concerns about the risk-benefit of treatment.

A recent study[1] used the French national medical database to evaluate the safety of oral propranolol at the population level. From this database, infants exposed to propranolol were identified and a comparison cohort of nonexposed children was selected. The cases were all infants < 3 years old who had received at least one dose of propranolol, given between 2014 and 2016. The aim was to determine whether cardiovascular, respiratory, or metabolic problems were any more frequent among children treated with propranolol compared with the untreated comparison group.

The authors subsequently excluded the infants who received only one dispensing and another 269 infants with some sort of underlying disease, leaving a final group of 1484 exposed infants who had received more than one dose. Standardized mortality ratios (SMRs) were calculated to compare the frequency of observed versus expected events between the treatment group and the comparison group.

Only two healthy children experienced cardiovascular events, with an SMR of 2.8 (95% confidence interval [CI], 0-6.7), meaning that it was not significant. The SMR for respiratory events was 1.7 (95% CI, 1.2-2.1); this result was primarily driven by an increased risk for bronchiolitis among treated infants. Finally, only three infants experienced metabolic events, for an SMR of 5.1, yielding a 95% CI that included zero. These data suggest an overall safe profile for the use of propranolol for treating infantile hemangioma in young infants.

Viewpoint

We may never have the opportunity to see randomized data for treatment of infantile hemangioma, so a population-based evaluation such as this one is very helpful in providing evidence on the safety of propranolol treatment. Certainly, any provider who has treated a significant number of infants with propranolol has treated some who had bradycardia or hypoglycemia (making the provider nervous). Guidelines suggest starting therapy with the infants under observation (in the hospital for infants < 8 weeks or postconception age < 48 weeks).

Monitoring large population databases such as this one allows infants to be assessed across the entire treatment course and suggests overall very low rates of potential side effects. Given how revolutionary the use of propranolol has been in the treatment of infantile hemangioma, careful monitoring and appropriate dosing of patients should allow many children to benefit from this treatment.

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