Table 2.
Rate of safety label changes
| Modified section of safety label | Rate (95% CI) of safety related label changes (per year on market) | Rate ratio (95% CI) | |
|---|---|---|---|
| Expedited drugs* | Standard drugs | ||
| Any section† | 0.94 (0.88 to 1.00) | 0.68 (0.63 to 0.73) | 1.38 (1.25 to 1.52) |
| Boxed warning | 0.04 (0.03 to 0.05) | 0.02 (0.02 to 0.04) | 1.62 (0.98 to 2.65) |
| Contraindication | 0.05 (0.03 to 0.06) | 0.03 (0.02 to 0.05) | 1.41 (0.91 to 2.19) |
| Warning | 0.24 (0.21 to 0.27) | 0.18 (0.15 to 0.21) | 1.39 (0.90 to 2.15) |
| Precaution | 0.35 (0.32 to 0.39) | 0.26 (0.23 to 0.29) | 1.38 (1.18 to 1.62) |
| Adverse reaction | 0.26 (0.23 to 0.29) | 0.19 (0.16 to 0.22) | 1.38 (1.15 to 1.66) |
| Boxed warning or contraindication | 0.08 (0.07 to 0.10) | 0.06 (0.04 to 0.07) | 1.48 (1.07 to 2.06) |
| Warning, precaution, or adverse reaction | 0.85 (0.80 to 0.91) | 0.62 (0.58 to 0.67) | 1.37 (1.24 to 1.51) |
*Includes accelerated approval, priority review, and fast track. Stratifying by each type yielded virtually identical results.
†Includes boxed warning, contraindication, warning, precaution, and adverse reaction sections.