QuarterWatch® Reports

Adverse Drug Events in Children Under Age 18

This QuarterWatch™ report analyzes 15 drugs that accounted for 41% of recent serious adverse events in children reported to the U.S. Food and Drug Administration (FDA) over the five years 2008-2012. In addition, we examine reporting trends from the same period for all domestic reports to the agency that identified adverse events in children under age 18.

Our study identified 45,610 adverse drug events reported in children less than 18 years of age. Of these, 64% (29,298) indicated a serious injury. Reports in children grew substantially over time - from 6,320 in 2008 to 11,401 in 2012, increasing at the same rate as for adult patients. Examined by year of age in children, the reports formed a U-shaped curve. The number was greatest in the first year of life, then declined and leveled off until adolescence, when cases again rose rapidly. There were insufficient data to evaluate 70% of the 741 drugs with reported serious adverse events in children because of fewer than 2 reports per year.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of prescription drugs after FDA marketing approval.