FDA Labeling Change: Additional Language to Mitigate the Risk of Hypoglycemia Associated with Beta Blockers in Children

During routine post-market surveillance, the U.S. Food and Drug Administration (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 evaluate hypoglycemia associated with beta blockers in this population.

Based on the totality of data from the FDA Adverse Event Reporting System, published case reports, the National Poison Data System, and the Sentinel System, 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.