Promethazine Prescribing Patterns in Pediatric Inpatients Younger than Two Years before and after the Product Black Box Warning

Abstract

PurposeA black box warning was added to promethazine's labeling in November 2004 related to reports of respiratory depression in children younger than 2 years. The objective of this study was to determine what effect the changes in product labeling had on prescribing practices for promethazine at a pediatric hospital 1 year before (2004), 1 year immediately after (2005), and 2 years after (2006).MethodsA retrospective chart review of orders for promethazine in pediatric inpatients (2 years and younger) admitted between 2004 and 2006 was conducted. Information collected included patient demographics and specifics about orders for promethazine (dose in mg/kg, route, indication, and number of as-needed doses received).ResultsA total of 255 orders for promethazine met study criteria. Though the number of promethazine orders decreased each year, there was no significant difference in promethazine use observed between 2004 and 2005 ( P = 0.223). However, a significant decrease in promethazine use occurred between 2005 and 2006 ( P = 0.017), a full year after the initial black box warning was released.ConclusionThe black box warning has affected the prescribing patterns at a pediatric institution, causing a decrease in promethazine use. The response to the warning was slow for some services, which indicates a need for better communication and dissemination of prescribing information to medical staff and health care professionals.