FDA Labeling Change: Oral Anticoagulants and Clinically Significant Uterine Bleeding

Cases of severe uterine bleeding associated with use of novel oral anticoagulants (ACs) have been reported in the FDA Adverse Event Reporting System (FAERS) and the medical literature. FDA conducted a Sentinel study to examine severe uterine bleeding events requiring medical intervention in women treated with oral ACs. Among 1,050,192 new users of oral ACs, the incidence rates of severe uterine bleeding with medical, transfusion, and surgical (e.g., hysterectomy, myomectomy) management were 0.6, 1.7, and 5.0 per 1000 person-years, respectively. These findings contributed to the following class-wide label change for oral ACs in Section 8.3, “The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including [PRODUCT name] should be assessed in females of reproductive potential and those with abnormal uterine bleeding.”