Exploration of the potential association between new oral anticoagulants and anxiety symptoms adverse events: Evidence from a real-world analysis.

OBJECTIVE

Healthcare professionals should be more concerned about the psychiatric status of patients on long-term maintenance anticoagulation therapy. Therefore, the aim of this study was to assess the potential risk association between new oral anticoagulants (NOACs) and psychiatric disorder adverse event through data mining in the FDA Adverse Event Reporting System (FAERS).

METHODS

This is a retrospective study of pharmacovigilance data from the FAERS. Safety signals for NOACs-associated asAEs were quantified by reporting the ratio of odds ratios (ROR) and information components (IC025), and the weibull shape parameter (WSP) test was used for statistical analyses of time to onset (TTO).

RESULTS

Only apixaban was positively associated with psychiatric adverse events (n = 16,978, ROR = 1.48, IC025 = 0.50). There were 1147 reports of apixaban-related adverse events involving anxiety symptoms, with anxiety (n = 1096) having the highest number of PTs and mixed anxiety and depression disorders (n = 12, ROR = 12.31, IC025 = 1.94) being the strongest-signaling PT. Patients presenting with anxiety symptoms were predominantly from the U.S., with the majority of patients being female (n = 566) and over the age of 65 (n = 483). The median time to anxiety symptoms after apixaban treatment was 40.5 days, and the WSP test identified apixaban as a randomized failure type.

CONCLUSION

Long-term use of apixaban might be associated with an increased risk of anxiety symptoms, and healthcare professionals need to pay more attention to the emotional state of patients on long-term maintenance anticoagulation therapy.