1.1. Pediatrics

In 2004, promethazine received a “black box” warning with contraindications for use in children under two years of age and strengthened warnings for use in children two years of age and older. These revisions resulted from repeated reports to the Food and Drug Administration (FDA) of serious, life-threatening adverse events in children. Between 1969 and 2003, the FDA received 125 reports of adverse events in the pediatric population including respiratory depression, apnea, or cardiac arrest (n = 38); dystonic reactions (n = 29); unspecified central nervous system reactions (n = 24); seizures or seizure-like activity (n = 15); dermatologic reactions (n = 12); and neuroleptic malignant syndrome (n = 5). All routes of administration were responsible for the outcomes observed with these events, which included hospitalization, life-threatening events, disability, and death. ^1-6

Due to the limitations placed on promethazine prescribing, all profiles for patients under two years of age containing prescriptions for promethazine will be reviewed.