Emerging adverse event signals of new analgesic suzetrigine: a disproportionality analysis of the FAERS database
Abstract
BACKGROUND: Suzetrigine, new non-opioid analgesic, does not cause respiratory depression and dependence, the main limiting factors for the use of opioids; however, its complete safety profile is not yet established.
OBJECTIVE: The aim of this study is first to review the adverse effects of suzetrigine published so far, and then to analyze the spontaneous reports of adverse events for suzetrigine in the FAERS database to identify possible signals of hitherto unknown adverse effects.
METHODS: The study's outcomes were the four standard disproportionality indices calculated for each adverse event reported: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Yule's Q, and Information Component (IC).
RESULTS: There are four signals of possible adverse effects of suzetrigine: paresthesia (ROR 19.62 ± 5.69, PRR 1.38 ± 0.36, IC 4.18 ± 0.41, Yules Q 0.90 ± 0.03), burning sensations (ROR 15.75 ± 7.26, PRR 2.43 ± 1.08, IC 3.93 ± 0.64, Yules Q 0.88 ± 0.05), a swollen tongue (ROR 13.04 ± 10.66, PRR 4.95 ± 4.00, IC 3.68 ± 1.08, Yules Q 0.86 ± 0.10), and abnormal dreams (ROR 23.49 ± 17.81, PRR 13.97 ± 10.44, IC 4.53 ± 1.01, Yules Q0.92 ± 0.06).
CONCLUSIONS: After the first year of widespread use of suzetrigine, there are only a few signals of possible side effects that were not observed in clinical studies, of which paresthesias have the highest probability of being a real side effect.
Suzetrigine is a new pain reliever that was recently approved for use in patients. Unlike…
Read the paper
Related studies
- Noninvasive and Point-of-Care Surface-Enhanced Raman Scattering (SERS)-Based Breathalyzer for Mass Screening of Coronavirus Disease 2019 (COVID-19) under 5 min
- De Novo Transcriptome Analysis and Detection of Antimicrobial Peptides of the American Cockroach Periplaneta americana (Linnaeus)
- Molecular Characterization and Expression Profiling of Tomato GRF Transcription Factor Family Genes in Response to Abiotic Stresses and Phytohormones
- Assembly of Tight Junction Strands: Claudin-10b and Claudin-3 Form Homo Tetrameric Building Blocks that Polymerise in a Channel-Independent Manner
- Update of the Pompe variant database for the prediction of clinical phenotypes: Novel disease‐associated variants, common sequence variants, and results from newborn screening
- Machine Learning-Based SERS Chemical Space for Two-Way Prediction of Structures and Spectra of Untrained Molecules
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.