From Bedside to Package Insert: Presentation of AEs in Product Labeling

The appropriate presentation of adverse event (AE) data in product labeling first requires that AEs be collected in a consistent and systematic fashion. Data from placebo-controlled trials, active-control trials, and uncontrolled trials require different analytic techniques and should usually be presented separately. The integrated summary of safety should form the basis for displaying AE data in product labeling. Federal regulations dictate which AEs must be described under “contraindications,” “warnings,” “precautions,” or “adverse reactions.” AEs that are likely due to drug treatment and that are either predictable in occurrence or serious need special attention; for these AEs, the demographic and medical characteristics of the population at risk should be defined. Cumulative rate curves may assist the reader in understanding the link between AE frequency and duration of treatment. Vague terminology (eg, “rare,” “uncommon”) should be avoided in the package insert.