rivaroxaban and Menorrhagia

Heavy menstrual bleeding (HMB) is a common complication of anticoagulation, affecting ∼70% of menstruating women receiving oral anticoagulants. The risk of HMB is lower with apixaban and/or dabigatran than with rivaroxaban. HMB can result in iron deficiency with or without anemia, increased need for medical interventions, decreased quality of life, and missed school/work. Mainstays of treatment include hormone therapies such as the levonorgestrel intrauterine system, subdermal implant, and other progesterone-based therapies, which can result in decreased blood loss and, in some cases, amenorrhea. Combined hormone therapies can be used while patients continue receiving anticoagulation and are also highly effective for decreasing menstrual blood loss. Rarely, procedure-based interventions such as endometrial ablation may be required. Patients should be evaluated for iron deficiency and anemia and offered supportive therapies as needed. Abbreviating the course of anticoagulation or skipping doses can increase the risk of recurrent venous thromboembolism by as much as fivefold, but switching oral anticoagulants may be considered. Awareness of HMB and careful history taking at each visit are crucial to avoid a missed diagnosis.

Topics: Adult; Anticoagulants; Female; Humans; Levonorgestrel; Menorrhagia; Pyrazoles; Pyridones; Quality of Life; Rivaroxaban; Venous Thromboembolism

Two-thirds of users of oral anticoagulants use direct oral anticoagulants, among which increasingly women in their reproductive age. The risk of severe or abnormal menstrual bleeding doubles to 70% when using anticoagulants. With rivaroxaban especially the risk seems higher than with vitamin K antagonists; with dabigatran possibly lower.. We saw a 49-year-old woman who started the oral contraceptive pill because of heavy menstrual bleeding. After getting deep vein thrombosis we stopped the pill and started rivaroxaban. Despite leuproreline the heavy bleeding persisted and 6 blood transfusions were necessary, after which the type of anticoagulant was changed. Eventually, we performed a hysterectomy.. Anticoagulants can cause severe menstrual bleeding, especially in women with a history of heavy menstrual periods. The type of anticoagulant can be changed and the bleeding can be treated by both hormonal and non-hormonal therapies.

Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Dabigatran; Female; Hemorrhage; Humans; Menorrhagia; Middle Aged; Rivaroxaban

Although heavy menstrual bleeding (HMB) is a known complication of anticoagulant therapy, rates of HMB in users of the direct oral anticoagulants (OACs) apixaban and rivaroxaban are largely unknown.. We performed a retrospective cohort study of menstruating women prescribed rivaroxaban, apixaban and warfarin over a six-year period (2012-2018). The primary outcome was HMB requiring medical or surgical intervention. We used descriptive statistics and logistic regression to evaluate associations between OAC type, age, history of HMB, and the primary outcome.. We identified 195 women of reproductive-age with a new therapeutic OAC prescription (62 on rivaroxaban, 54 on apixaban, 79 on warfarin). A minority (26/195, 13.3%) had a documented history of HMB, including 9 rivaroxaban users, 7 apixaban users and 10 warfarin users but most women (117/195, 60%) had no menstrual history documented. One third of subjects (64/195) required treatment for HMB within 6 months of starting OAC therapy. After controlling for a history of HMB, rivaroxaban users were 1.4 times more likely to require treatment as compared to users of other OACs.. We found an association between rates of HMB necessitating medical or surgical intervention and rivaroxaban use. We also found that the majority of women did not have a documented menstrual history, suggesting that many providers do not inquire about menstrual bleeding when starting OAC therapy. Menstruating women, particularly those with a history of HMB, may be at increased risk for HMB necessitating medical treatment depending on the type of OAC used.

Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Dabigatran; Female; Humans; Menorrhagia; Pyridones; Retrospective Studies; Rivaroxaban

: A high risk of venous thromboembolism (VTE) recurrence requires extended anticoagulation but limits the options to control heavy menstrual bleeding (HMB) in women of reproductive age. We report the management of HMB in a 48-year-old woman with a history of menometrorrhagia, recurrent VTE and multiple VTE risk factors. Due to the occurrence of HMB during extended rivaroxaban treatment, the presence of a uterine fibroid and the contraindication to interrupt anticoagulation for high risk of VTE recurrence, she received hormonal treatment first with a gonadotropin-releasing hormone agonist and then with progestin. This strategy allowed to adequately control HMB, without rivaroxaban discontinuation or dose reduction, and no new thromboembolic and no more bleeding events occurred over a long follow-up period of more than 20 months. In conclusion, the use of hormonal therapy in VTE women requiring long-term anticoagulation may be an option to control HMB, without further increasing the risk of VTE recurrence.

Topics: Anticoagulants; Disease Management; Female; Gonadotropin-Releasing Hormone; Humans; Menorrhagia; Middle Aged; Progestins; Recurrence; Rivaroxaban; Treatment Outcome; Venous Thromboembolism

Anticoagulant-associated heavy menstrual bleeding (HMB) is an underrecognized but not uncommon problem in clinical practice. Premenopausal women should be advised of the potential effect of anticoagulant therapy on menstrual bleeding at the time of treatment initiation. Consequences of HMB should be assessed and treated on an ongoing basis. In the acute setting, the decision to withhold anticoagulants is based on an individual patient's risk of thrombosis and the severity of the bleeding. For women who require long-term anticoagulation, a levonorgestrel intrauterine system, tranexamic acid (during menstrual flow), high-dose progestin-only therapy, or combined hormonal contraceptives are effective for controlling HMB. The risk of thrombosis during anticoagulant therapy with these treatments is not well studied but is likely to be low. Selection of type of hormonal therapy is based on patient preference, other indications for and contraindications to therapy, adverse effect profile, and ongoing thrombotic risk factors. Women who do not respond to medical treatment or who do not wish to retain their fertility should be considered for surgical management.

Topics: Adult; Anticoagulants; Antifibrinolytic Agents; Dose-Response Relationship, Drug; Female; Humans; Menorrhagia; Practice Guidelines as Topic; Pulmonary Embolism; Rivaroxaban; Tranexamic Acid; Treatment Outcome; Venous Thromboembolism; Young Adult

Topics: Adolescent; Adult; Factor Xa Inhibitors; Female; Humans; Menorrhagia; Middle Aged; Pulmonary Embolism; Rivaroxaban; Venous Thrombosis; Young Adult

Observational data and results from post-hoc analyses in clinical trials suggest that direct oral factor Xa inhibitors might increase menstrual bleeding intensity in women of reproductive age, but the extent of this effect is unknown. We aimed to investigate the management and outcomes of vaginal bleeding complications during therapy with direct oral factor Xa inhibitors in a case series of women of reproductive age.. To identify individuals for inclusion in this case series, we searched two sources of prospectively collected data from women of reproductive age treated with direct oral factor Xa inhibitors: the non-interventional Dresden NOAC Registry (NCT01588119), which is based in the administrative district of Dresden (Saxony, Germany), and all locally archived data from phase 3 trials of direct oral factor Xa inhibitors done at University Hospital Carl Gustav Carus Dresden. Vaginal bleeding events were defined as any vaginal bleeding complications as reported by the patient. We collected data on type and dosage of anticoagulation; suspected or confirmed bleeding events, hospital admissions, and mortality; and pattern and management of vaginal bleeding events. For all cases of bleeding identified, we reviewed all available source data to identify examination results suggesting potential underlying anatomical causes of bleeding.. We identified 178 women of reproductive age who received direct oral factor Xa inhibitor therapy, of whom 57 had vaginal bleeding events, including 50 who received rivaroxaban, six who received apixaban, and one who received edoxaban. These 57 women had 72 vaginal bleeding events, including 59 cases of heavy menstrual bleeding and 13 bleeding events unrelated to the menstrual cycle. 51 (86%) of these heavy menstrual bleeding events (two major bleeding events, 17 clinically relevant non-major bleeding events, 32 minor bleeding events) were treated conservatively (eg, change of oral hormone therapy or reduction, temporary interruption, or discontinuation of direct oral factor Xa inhibitor) and the remaining eight (14%) events (three major bleeding events and five clinically relevant non-major bleeding events) required elective surgical or interventional treatment (hysterectomy, curettage, ovary excision, or excision of ovarian cysts). Of the 57 women, 13 (23%) had a second bleeding event and two (4%) had a third event. Nine patients had underlying anatomical abnormalities; compared with patients without abnormalities, these patients had more intense bleeding, more had recurrent bleeding (five [56%] of nine patients with abnormalities vs eight [17%] of 48 patients without abnormalities), and more needed surgical treatment for bleeding (eight [89%] of nine vs zero of 48).. Vaginal bleeding, particularly heavy menstrual bleeding, is a common complication in women of reproductive age on direct oral factor Xa inhibitor therapy. Most cases can be treated conservatively, but patients with severe or recurrent vaginal bleeding complications should be assessed for underlying anatomical abnormalities, which might require surgical or interventional treatment. Further data are needed to provide guidance on prevention and treatment of vaginal bleeding complications in this patient population.. None.

Topics: Administration, Oral; Adult; Anticoagulants; Atrial Fibrillation; Factor Xa Inhibitors; Female; Hormone Replacement Therapy; Humans; Menorrhagia; Middle Aged; Progesterone; Prospective Studies; Pyrazoles; Pyridines; Pyridones; Rivaroxaban; Thiazoles; Uterine Hemorrhage; Venous Thromboembolism