Association of antidepressants plus antithrombotics and bleeding risk: a pharmacovigilance study.

AIM: The present study investigated the risk of bleeding when antidepressants are added to antithrombotics.

METHODS

Using data registered in VigiBase®, the WHO pharmacovigilance database, between 01/01/2000 and 31/12/2022, we compared the risk of reporting "serious" bleeding (Reporting Odds Ratio, ROR) with antidepressants + antithrombotics versus antithrombotics alone.

RESULTS

Increased values of ROR were found for the association Serotonin Reuptake Inhibitors (SRIs) + Direct Oral Anticoagulants (DOACs) versus DOACs alone (ROR=1.49(1.17-1.89)). Similar results were found for Factor Xa inhibitors or Thrombin inhibitors. This association was also found for other antithrombotics: Vitamin K Antagonists (ROR=1.37(1.12-1.68)), Platelet Aggregation Inhibitors PAIs (ROR=1.38(1.21-1.57)) and Heparins (2.04(1.59-2.62)) but not with other antidepressants (Non-Selective Monoamine Reuptake Inhibitors, NSMRIs).

CONCLUSION

The present study suggests an increased risk of "serious" bleeding when SRIs (but not NSMRIs) are associated with antithrombotics (all antithrombotics and not only DOACs).