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Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Severe Uterine Bleed

Basic Details
Status
Complete
Last Updated
Monday, May 24, 2021
Original Posting Date
Health Outcome(s)
severe uterine bleed
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Regulatory Determination / Use

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.”

Analytic Code Link(s) (1)
Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Analysis
Result(s) (3)
Incidence of Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Descriptive Analysis Severe Uterine Bleed Following Novel Oral Anticoagulants Use: A Propensity Score Analysis Incidence Rate of Severe Uterine Bleeding Among New Users of Oral Anticoagulants: A Descriptive Analysis
Regulatory Link(s) (3)
Drug Safety-related Labeling Change (Xarelto) Drug Safety-related Labeling Change (Pradaxa) Drug Safety-related Labeling Change (Eliquis)
Related Publication(s) and/or Presentation(s) (3)
Publication: Risk of Severe Abnormal Uterine Bleeding Associated with Rivaroxaban Compared with Apixaban, Dabigatran and Warfarin Publication: Incidence of Uterine Bleeding following Oral Anticoagulant Use in Food and Drug Administration’s Sentinel System Publication: Incidence of Severe Uterine Bleeding Outcomes among Oral Anticoagulant Users and Nonusers