Skip to main content

Angiotensin-Converting Enzyme (ACE) Inhibitors and Angiotensin II Receptor Blockers (ARBs) & Pediatric Drug Utilization

    Basic Details
    Last Updated
    Thursday, June 13, 2024
    Original Posting Date
    Health Outcome(s)
    pediatric drug utilization
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    FDA initiated this study in the Sentinel System to gather data on drug utilization of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) in various subgroups of patients aged less than one year. Product labeling for renin-angiotensin system (RAS) inhibitors, including ACE inhibitors and ARBs, has varying recommendations for indicated pediatric populations (i.e., enalapril is approved for patients aged greater than one month; candesartan is approved for patients aged greater than one year, etc.). RAS inhibition causes fetal and neonatal abnormalities when used late in pregnancy by the mother and the effects of inhibition on the developing human kidney (during the first year of life) are unknown. FDA sought to quantify the degree of prescribing of products affecting the RAS system in various pediatric age groups. Results of this study estimated the number of prevalent users and dispensings of ACE inhibitors and ARBs among these pediatric populations. This study provided pediatric drug utilization data that helped inform the review of some applications for ACE inhibitors and ARBs.