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.