Emerging adverse event signals of new analgesic suzetrigine: a disproportionality analysis of the FAERS database

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.