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How I Treat Heavy Menstrual Bleeding Associated With Anticoagulants

Xarelto can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Xarelto. These lists don’t include all possible side effects.For more information on the possible side effects of Xarelto, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to report to the FDA a side effect you’ve had with Xarelto, you can do so through MedWatch.Mild side effectsThe mild side effects of Xarelto that are more common* can include:fatigue (lack of energy)belly painback painmuscle spasmdizzinessfaintinganxietydepressiontrouble sleepingitching* These side effects occurred in more than 1% of people in clinical studies.Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.Serious side effectsSerious side effects from Xarelto can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.Serious side effects, which are explained in more detail below in “Side effect details,” include:increased risk of bleedingsevere allergic reactionincreased risk of blood clots if you stop taking Xarelto*risk of spinal or epidural blood clots if you have a spinal injection while you’re taking Xarelto* * Xarelto has a boxed warning from the FDA regarding the risk of blood clots if you stop using the drug. It also has a boxed warning regarding the risk of spinal or epidural blood clots if you have a spinal injection while you’re using the drug. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous. Side effect detailsYou may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.Allergic reactionAs with most drugs, some people can have an allergic reaction after taking Xarelto. But it’s not known how often this occurs in people taking this drug.Symptoms of a mild allergic reaction can include:skin rashitchinessflushing (warmth and redness in your skin)A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:swelling under your skin, typically in your eyelids, lips, hands, or feetswelling of your tongue, mouth, or throattrouble breathingCall your doctor right away if you have a severe allergic reaction to Xarelto. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.BleedingXarelto increases your risk of bleeding. This is because the drug makes it harder for your blood to form clots. While you’re taking Xarelto, you may notice that you bruise more easily than usual. You may also find that it takes longer than usual for you to stop bleeding.Sometimes, bleeding from a damaged blood vessel can cause blood to build up and clot in the tissues surrounding the blood vessel. This formation is called a hematoma. If the hematoma is under your skin or inside a muscle, it could cause a painful lump or swelling.But keep in mind that bleeding can occur anywhere in your body. This includes internal bleeding, such as in your stomach, intestines, abdomen (belly), lungs, kidneys, liver, brain, joints, and eyes. In some cases, the bleeding can be serious and may lead to death.If you have severe bleeding while you’re taking Xarelto, you may need a blood transfusion. You may also need medication to reverse the effect of Xarelto in your body. For more information about this, see the “Reversal of Xarelto” section below.How common is it to bleed while using Xarelto?In clinical studies, major bleeding occurred in 0.3% to 3.6% of people taking Xarelto. In comparison, major bleeding occurred in:3.5% of people who took warfarin (Jantoven)*0.1% to 1.7% of people who took enoxaparin (Lovenox)*0.3% to 0.9% of people who took aspirinThe rates of bleeding varied depending on the dosage of each drug that was given and any other drugs it was used with. The rates also varied depending on the condition being treated.* Warfarin (Jantoven) and enoxaparin (Lovenox) are other commonly used anticoagulant (blood thinning) medications.What are possible symptoms of bleeding while using Xarelto?Symptoms of potentially serious bleeding can vary, but they may include:any bleeding that’s severe, lasts a long time, or won’t stopfrequent nosebleedsunusual bleeding from your gumsunexpected vaginal bleeding or menstrual bleeding that’s heavier than usualblood in your urine, which may be red, pink, or brown in colorblood in your stool, which may be red or black in color, or look like tarvomiting blood, which may be red or pink in color, or look like coffee groundscoughing up blood that looks like coffee groundssevere headachedizziness, which could be a sign of low blood pressure that’s caused by internal bleedingjoint painpain, swelling, or bleeding at any woundsIf you have any symptoms of serious bleeding, call your doctor right away. If your symptoms feel life threatening, call 911.Side effects in older peopleBased on clinical studies, older people using Xarelto are more likely to have problems with bleeding than younger people are.One clinical study looked at people with atrial fibrillation (A-fib) who were taking Xarelto to prevent blood clots and stroke. In the study, major bleeding occurred in 4.9% of people ages 75 years and older who were taking Xarelto. This is compared with major bleeding occurring in 4.4% of people ages 75 and older who were taking warfarin.In comparison, major bleeding occurred in 2.2% of people less than 65 years of age who were taking either Xarelto or warfarin.If you’re concerned about the risks of Xarelto treatment given your age, talk with your doctor. They can discuss with you the risks and benefits of using this drug.FatigueXarelto may make you feel tired or fatigued (lacking energy).In a clinical study of people taking Xarelto to treat a deep vein thrombosis (DVT), 1.4% of people had fatigue. In comparison, fatigue occurred in 0.9% of people with a DVT who took both enoxaparin (Lovenox) and another blood thinner drug, such as warfarin (Jantoven). (Enoxaparin and warfarin are other anticoagulant medications.)If you feel tired or fatigued while you’re taking Xarelto, talk with your doctor. They can recommend ways to help improve your energy level.Blood clotsEven though Xarelto lowers your risk of having blood clots, it’s still possible to have a blood clot while you’re taking the drug.In fact, Xarelto has boxed warnings for blood clots. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous. The boxed warnings for Xarelto are described below.Risk of blood clots if you stop taking XareltoStopping Xarelto treatment increases your risk of having a blood clot. And if you have heart disease or disease that affects your arteries, stopping Xarelto increases your risk of heart attack and stroke. Don’t stop taking Xarelto unless your doctor recommends that you do.Sometimes Xarelto needs to be stopped temporarily. For example, this may be recommended before you have a surgical, medical, or dental procedure. In this case, your doctor will tell you when to stop Xarelto and when to start taking it again. In the meantime, your doctor may prescribe another drug for you to take to help prevent blood clots while you’re not taking Xarelto.Risk of spinal or epidural hematomaIf you have a spinal or epidural injection* while you’re taking Xarelto, there’s a risk that the injection could cause bleeding around your spine or brain. This could lead to either a spinal or epidural hematoma. (With a spinal hematoma, you have a buildup of blood around your spine. With an epidural hematoma, you have a buildup of blood around your brain.) Developing a hematoma in your spine or brain could cause long-lasting or even permanent paralysis.Having a lumbar puncture (spinal tap) also increases the risk of spinal or epidural hematoma. The risk is higher as well if you take drugs that affect your ability to form blood clots. (These medications include nonsteroidal anti-inflammatory drugs [NSAIDs] and blood thinners.) In addition, the risk is higher if you have had difficult or repeated epidural or spinal punctures in the past, have a history of problems with your spine, or have had surgery on your spine.If you need a spinal or epidural injection while you’re using Xarelto, your doctor will monitor you for spinal blood clots. Tell your doctor right away if you have any back pain, tingling, numbness, or muscle weakness, especially in your legs and feet, while you’re taking Xarelto. Also tell your doctor right away if you lose control of your bladder or bowels.* Spinal and epidural injections are used to give certain medications, such as anesthetics or pain relievers. With either injection, a needle is inserted in your back, into the area around your spine. The risk of spinal or epidural hematoma is higher if you have a thin tube (called a catheter) placed into your spine to deliver medication.ItchingSome people have itching while they’re taking Xarelto. For example, in a clinical study of people taking Xarelto to treat blood clots in their lungs, 2.2% had itching. This side effect was reported in 1.1% of people taking both enoxaparin (Lovenox) and another blood thinner drug, such as warfarin (Jantoven). (Enoxaparin and warfarin are other anticoagulant drugs.)Other clinical studies looked at people taking Xarelto to prevent blood clots after they’d had hip or knee replacement surgery. In these people, 2.1% of those taking Xarelto had itching. In comparison, 1.8% of people who took enoxaparin had itching.Keep in mind that sometimes itchy skin or a rash can be a sign of an allergic reaction to the drug. For more information about this, see the “Allergic reaction” section above.If you have itching or a rash while you’re taking Xarelto, call your doctor. Your doctor can check to see what’s causing your symptoms. And they’ll recommend whether you need any medical treatment.DizzinessXarelto may cause dizziness in some people taking the drug. And in some cases, Xarelto may make you feel faint.In one clinical study of people taking Xarelto to treat a deep vein thrombosis (DVT), 2.2% of people had dizziness. In comparison, 1.3% of people taking both enoxaparin (Lovenox) and another blood thinner drug, such as warfarin (Jantoven), had dizziness. (Enoxaparin and warfarin are other anticoagulant drugs.)Other clinical studies looked at people taking Xarelto to prevent blood clots after they’d had hip or knee replacement surgery. In these people, 1.2% of people who took Xarelto had fainting. In comparison, 0.7% of people who took enoxaparin had fainting.If you feel dizzy, lightheaded, or faint while you’re taking Xarelto, call your doctor right away. These symptoms can sometimes be a sign of internal bleeding. If your symptoms feel life threatening, call 911.Stomach painYou may get abdominal (belly) or stomach pain while you’re taking Xarelto.In a clinical study of people taking Xarelto to treat deep vein thrombosis (DVT), 2.7% had abdominal pain. In comparison, 1.5% of people taking both enoxaparin (Lovenox) and another blood thinner drug, such as warfarin (Jantoven), had abdominal pain. (Enoxaparin and warfarin are other anticoagulant drugs.)If you have unexplained belly pain while you’re taking Xarelto, call your doctor. Sometimes this symptom can be a sign of internal bleeding. If your symptoms feel life threatening, call 911.Muscle painSome people have muscle pain or spasms while they’re taking Xarelto. Back pain and extremity pain has also been reported in people taking this drug.In a clinical study of people using Xarelto to treat a deep vein thrombosis (DVT), 2.9% had back pain. In comparison, 1.8% of people taking both enoxaparin (Lovenox) and another blood thinner drug, such as warfarin (Jantoven), had back pain. (Enoxaparin and warfarin are other anticoagulant drugs.)In the same study, 1.3% of people taking Xarelto had muscle spasms. In comparison, 0.8% of people taking both enoxaparin and another blood thinner drug, such as warfarin, had muscle spasms.Clinical studies also looked at people taking Xarelto to help prevent blood clots after hip or knee replacement. In these people, 1.2% had muscle spasms. In comparison, muscle spasms occurred in 0.7% of people who took enoxaparin.In the same studies, 1.7% of people taking Xarelto had pain in their extremities. This side effect was also reported in 1.2% of people who took enoxaparin.If you have pain in your muscles or any other areas of your body while you’re taking Xarelto, talk with your doctor. They can recommend ways to help improve your symptoms.InsomniaIt’s possible to have insomnia (trouble sleeping) while you’re taking Xarelto.In a clinical study of people taking Xarelto to treat a deep vein thrombosis (DVT), 1.6% of people had insomnia. In comparison, insomnia occurred in 1.1% of people taking both enoxaparin (Lovenox) and another blood thinner drug, such as warfarin (Jantoven). (Enoxaparin and warfarin are other anticoagulant drugs.)If you have trouble sleeping while you’re taking Xarelto, talk with your doctor or pharmacist. They can suggest ways to help improve your quality of sleep.ThrombocytopeniaSome people taking Xarelto have had thrombocytopenia (low platelet level). Platelets are blood cells that help your body to form clots. Having thrombocytopenia increases your risk of bleeding or bruising more often than usual.Xarelto doesn’t work by lowering your platelets, and low platelet levels weren’t reported in people who took Xarelto during clinical studies. However, this side effect was reported in some people who took Xarelto after it was released onto the market.If you’re concerned about having a low platelet level while you’re using Xarelto, talk with your doctor.Hair lossHair loss wasn’t reported during clinical studies of Xarelto. However, after the drug’s release onto the market, some cases of hair loss have been reported in people taking Xarelto.It’s not certain whether these cases of hair loss were definitely caused by Xarelto or not. But other anticoagulant (blood thinning) drugs, such as warfarin (Jantoven) and heparin, are known to cause hair loss. So it’s possible that hair loss may be associated with Xarelto as well.If you’re concerned about hair loss while you’re taking Xarelto, talk with your doctor.Weight gain (not a side effect)Weight gain wasn’t reported as a side effect during clinical studies of Xarelto.If you’re concerned about weight gain while you’re taking Xarelto, talk with your doctor. They can recommend ways to help you manage a body weight that’s healthy for you.

Video about How I Treat Heavy Menstrual Bleeding Associated With Anticoagulants

Management of anticoagulant-associated heavy menstrual bleeding

Heavy menstrual bleeding (HMB), in clinical practice, refers to clinically excessive menstrual blood loss that interferes with a woman’s physical, social, emotional, and/or material quality of life. HMB affects approximately 10-35% of women but can be as common as 70% of women on oral anticoagulation. Oral anticoagulation can increase both the duration and the degree of menstrual bleeding. Observational data suggests that HMB might be more common among women on rivaroxaban or edoxaban as compared to apixaban, dabigatran or vitamin K antagonists (VKAs). HMB can result in iron deficiency anemia, can have a significant psychosocial impact on women and frequently goes unrecognized among anticoagulated women. Symptoms surrounding HMB should be elicited at the first visit, prior to prescribing anticoagulation. Premenopausal women should be made aware that HMB may occur upon starting anticoagulation therapy and should be encouraged to discuss HMB with their physician if it occurs. Both hormonal contraceptives and antifibrinolytic therapy can be used to reduce oral anticoagulant-associated HMB. Temporary interruption of anticoagulation during menstrual bleeding should be avoided as it has been associated with an increased risk of recurrent VTE. Rotation of anticoagulation to an alternative agent, such as apixaban or dabigatran, can be considered. Procedural interventions, such as endometrial ablation or uterine artery embolization, may rarely be required. Referral to a gynecologist is warranted when a specific etiology is suspected for which targeted management is required.
This presentation is by Dr Joseph Shaw from the 2021 Thrombosis Canada annual conference.

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