Details
Hypoglycemia is a well-known adverse reaction associated with beta blocker use. During routine post-market surveillance, the FDA identified a case report describing severe hypoglycemia in an infant associated with nadolol therapy for infantile hemangioma. While select beta blockers are approved by the FDA for specific pediatric indications including hypertension (metoprolol succinate), hemangioma (Hemangeol, an oral propranolol solution), and lowering of intraocular pressure (timolol ophthalmic solution), various beta blockers may be used for a range of off-label conditions in this population. The hypoglycemia safety signal and the limited understanding of the magnitude and patterns of beta-blocker use in the pediatric population prompted a Sentinel study to comprehensively characterize beta blocker use and assess the incidence of hypoglycemia associated with various beta blockers in this population.
Findings indicated that beta blockers were used for a variety of cardiac and non-cardiac conditions in the pediatric population, with potential indications for use varying by age groups. Notably, the study found that beta blocker use for indications approved by the FDA (Hemangeol for hemangioma and metoprolol succinate for hypertension) accounted for only 2% of all beta blocker use in the pediatric population. Additionally, children five years of age and younger appeared to be more prone to experience hypoglycemia following beta-blocker initiation.
Data from the FDA Adverse Event Reporting System, published case reports, the National Poison Data System, and this Sentinel study suggest that the association between beta blocker exposure and hypoglycemia in the pediatric population was observed with products across the beta blocker class. Based on the totality of data, the FDA approved safety-related labeling changes for beta blocker products to describe the risk of hypoglycemia in pediatrics or individuals unable to communicate signs of hypoglycemia. These changes are captured in the “Warnings and Precautions” and “Patient Counseling Information” sections of the Prescribing Information.