The safety analysis of lurasidone based on the real-world data of FAERS database

To assess lurasidone's real-world safety via retrospective analysis of post-marketing adverse reactions.

Signal mining was carried out by retrieving the adverse events (AEs) associated with lurasidone from the FDA Adverse Event Reporting System (FAERS) database spanning from the first quarter of 2011 to the fourth quarter of 2023. Disproportionality analyses including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and empirical Bayesian geometric mean (EBGM) were used to assess the presence of significant associations between lurasidone and AEs.

From the 10,176,406 reports collected in the FAERS database, a total of 12,451 reports of lurasidone-related AEs were identified, which focused on Psychiatric disorders (n = 8950), notably, akathisia and parkinsonian rest tremor are strongly associated with lurasidone; Breast engorgement, galactorrhea, breast discharge, and umbilical cord around neck and new ocular AEs including oculogyric crisis, excessive eye blinking, and blepharospasm, have not been mentioned in the specification. The most common and most severe PT reported was off-label use, followed by suicidal ideation.

This study reveals known and unexpected AEs about lurasidone, related to the eye, lactating women and life-threatening threats, and underscores the need for ongoing post-marketing surveillance of lurasidone.