Table 4.
Signal scores regarding drug misuse-, abuse-, and withdrawal-related AERs for semaglutide, other glucagon-like peptide-1 (GLP-1) analogues (dulaglutide, liraglutide, exenatide, lixisenatide, tirzepatide, and albiglutide), and the phentermine–topiramate combination. Data source: Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS; 2018–2022).
| Semaglutide vs. other GLP-1 Analogues | Semaglutide vs. Phentermine–Topiramate | |||||||
|---|---|---|---|---|---|---|---|---|
| PT (MedDRA) | PRR (FDR) | ROR (FDR) | IC025 (FDR) | EB05 (FDR) | PRR (FDR) | ROR (FDR) | IC025 (FDR) | EB05 (FDR) |
| Accidental overdose | 0.59 (0.60) | 0.59 (0.60) | −1.62 (0.34) | 0.50 (0.41) | Inf (<0.01) | Inf (<0.01) | −1.41 (0.50) | 0.99 (0.52) |
| Drug abuse | 4.05 (<0.01) | 4.05 (<0.01) | −0.63 (0.16) | 0.80 (0.12) | Inf (<0.01) | Inf (<0.01) | −1.74 (0.52) | 0.99 (0.53) |
| Drug level increased | 0.85 (0.46) | 0.85 (0.46) | −1.12 (0.27) | 0.62 (0.29) | Inf (<0.01) | Inf (<0.01) | −1.21 (0.49) | 0.99 (0.52) |
| Drug withdrawal syndrome | 4.05 (<0.01) | 4.05 (<0.01) | −0.63 (0.16) | 0.80 (0.12) | Inf (<0.01) | Inf (<0.01) | −1.74 (0.52) | 0.99 (0.53) |
| Incorrect route of product administration | 0.55 (0.61) | 0.55 (0.61) | −1.65 (0.34) | 0.48 (0.42) | Inf (<0.01) | Inf (<0.01) | −1.34 (0.50) | 0.99 (0.52) |
| Intentional product misuse | 0.42 (0.64) | 0.42 (0.64) | −1.68 (0.35) | 0.40 (0.45) | 0.32 (<0.01) | 0.32 (<0.01) | −1.01 (0.48) | 0.99 (0.53) |
| Intentional product use issue | 1.80 (<0.01) | 1.80 (<0.01) | 0.08 (<0.01) | 1.11 (<0.01) | Inf (<0.01) | Inf (<0.01) | −0.54 (0.41) | 0.99 (0.50) |
| Overdose | 0.92 (0.46) | 0.92 (0.46) | −0.66 (0.17) | 0.72 (0.19) | Inf (<0.01) | Inf (<0.01) | −0.71 (0.44) | 0.99 (0.51) |
| Prescription drug used without a prescription | 3.60 (<0.01) | 3.60 (<0.01) | −0.42 (0.10) | 0.85 (0.08) | Inf (<0.01) | Inf (<0.01) | −1.50 (0.51) | 0.99 (0.53) |
| Substance use | Inf (0.70) | Inf (0.70) | −0.29 (0.06) | 0.91 (0.04) | Inf (0.04) | Inf (0.04) | −1.74 (0.53) | 0.99 (0.53) |
Boldface denotes significance at FDR < 0.05; Signal scores for drug–event pairs less than 5 are not shown. Abbreviations: EB05: Bayesian empirical geometric mean (lower 5th percentile of the posterior observed-to expected distribution); FDR: false discovery rate; GLP-1: glucagon-like peptide-1; IC025: information component; the IC025 value is the lower limit of a 95% credibility interval for the IC; MedDRA: Medical Dictionary for Regulatory Activities; PRR = proportional reporting ratio; PT: preferred terms; ROR: reporting odds ratio.