Uncontrolled Bleeding Side Effects Linked To Xarelto

Xarelto (rivaroxaban) side effects include several types of uncontrolled bleeding which may pose a serious threat of injury and even death. Patients under treatment with this drug must be warned about the significant risks of adverse reactions such as bleedings, blood clots, strokes and internal hemorrhages. The U.S. Food and Drug administration even issued the “Black Box”, the most threatening warning on this blood thinner’s label. Our guide will list all the most dangerous complications as well as the minor ones.

According to the medication’s monograph, the most common Xarelto side effects are the bleeding complications. However, several types of bleeding may threaten a patient’s health and, in some circumstances, even his or her life. Some external hemorrhages can, in fact, be obviously manifest like gum or hemorrhoidal bleedings, while some other hidden ones like the dreaded gastrointestinal bleeding and the internal hematomas can be much more subtle and dangerous indeed. Let’s give a look to all the different bleeding types to know more about them.

Brain Bleeding

One of the most dangerous types of Xarelto bleeding is the lethal brain bleeding (a type of stroke). Although only a single case study described a case of intracranial hemorrhage caused by the use of rivaroxaban, there is still a risk of brain bleeding associated with the use of this drug. Rivaroxaban full prescribing information does, in fact, include a risk of intracranial bleeding among the others described, albeit at a seemingly lower rate than with other Vitamin K inhibitors such as Warfarin. Just like any other anticoagulant, this medication is associated with several bleeding events. What makes this drug stand out from its competitors, however, is the fact that there’s no antidote available to reverse its effects once they’re set in. Just like any other uncontrolled bleeding event, a cerebral hemorrhage may require hours to subside, while doctors cannot do much else than just waiting for the drug to be flushed out from the patient’s body.

Why is Xarelto linked to Brain Bleeding?

An intracranial bleed is a type of stroke in which a brain vessel ruptures causing blood to leak into nearby tissues. The blood that is collected in the brain tissues irritates them, causing swelling (edema) as well as cellular death due to its toxicity. Blood and fluids start accumulating, forming a mass of clotted blood called hematoma which may exert a certain pressure on nearby regions which may reduce local perfusion. As the other regions receive less blood, the oxygen supply may become inadequate, causing more cells to die in a relatively short time span. Cerebral blood clots formed may even migrate to other regions of the brain or the body or the body. If a blood pouch bursts out on or near the brain surface, it may fill the space between the skull and the brain, causing a subarachnoid hemorrhage or a subdural hematoma.

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How does brain bleeding occur?

If a part of the brain loses its blood supply for too much time, it may stop working, causing an ischemic stroke. Consequences of a stroke may vary, depending on the size and severity of the areas involved, and may range from simpler symptoms such as impaired vision or speech, weakness on one side, loss of balance or coordination, confusion, or even sudden seizures and coma. Sometimes symptoms of brain hemorrhage may progress slowly over the course of many days, while other times they may be abrupt and worsen in a matter of minutes. Strokes may be very insidious and dangerous, as they cannot be seen from the outside, and can only be confirmed by a CT scan.

Xarelto Gastrointestinal Bleeding

Gastrointestinal bleeding (GI bleeding) is one of the most common forms of hidden bleeding caused by this dangerous blood thinner. Several studies pointed out how GI bleeding is more frequent in patients treated with rivaroxaban than those treated with Warfarin. Gastrointestinal bleeding rates in patients treated with rivaroxaban were, in fact, 42% higher than Warfarin GI hemorrhage rates, and tend to be more frequent and severe among older patients aged 75 years or over. GI bleeding risk is higher when patients are prescribed other anticoagulants such as antiplatelet agents or nonsteroidal anti-inflammatory drugs (NSAIDs)

This form of hemorrhage can be so small that only lab tests can detect it, but still be threatening because of the long-term effects of blood loss. Gastrointestinal bleedings can happen in any tract of the digestive tract including the esophagus, stomach, small intestine, colon, rectum, and anus. Hemorrhoidal bleedings (piles) are included in this category, as lower digestive tract hemorrhages. Piles can ben painful or painless, depending whether they become swollen and inflamed or not. Constipation and increased abdominal pressure can be the cause of hemorrhoids, and always represent detrimental factors to their development. This type of bleeding in patients under treatment with this drug can be more concerning than usual, and frequently require additional examination to be fully evaluated. Profuse bleeding from the hemorrhoids which can’t be stopped may require emergency treatment

Xarelto External bleeding

External bleeding include all kind of bleedings caused by cuts and perforations. Even holding a knife can be dangerous while under treatment with this anticoagulant, as the lack of an antidote prevents doctors from stopping the bleeding. Immediate application of a firm, direct pressure on the wound can help staunch the bleeding. However, due to the anticoagulant action of the medication, you may need to press for a longer time than usual before the bleeding stops. If blood does not stop pouring out after a while, you should check immediate help. Even minor bleeding accidents such as a nosebleed or a gum bleeding provoked by toothbrushing should never be underestimated. Try to avoid forceful nose blowing, and buy a toothbrush with soft bristles to reduce the chance of a gum bleeding. The most common forms of external bleeding include:  Gum Bleeding, Nose Bleeding, Skin Bleeding, Bright red blood in vomit, Vomit that looks like coffee grounds, Black or tarry stool, or covered with bright red blood, Pain and irritation around the anal area, Unusual headaches, Constant fatigue and/or dizziness, Pale skin.

Menstrual Bleeding

For women taking rivaroxaban, experiencing longer or heavier menstruations is a common side effect. However, uncontrolled menstrual bleeding can also represent a risk that should be addressed immediately. If you experience a bleeding during your menstrual cycle that is heavier than normal, you should call your doctor or seek medical help as soon as possible. Vaginal bleeding can also be caused by external traumas or during normal sex intercourse.

Other Hidden Bleedings Caused By Xarelto

The hidden bleedings include all kind of small injuries and trauma which can lead to internal hemorrhages. Even a simple accident like a fall can be very dangerous while under treatment with Xarelto. Basic safety precautions are of paramount importance for any patient who wishes to avoid ending in an emergency room, and even small bruises should never be underestimated. Internal bleeding caused by trauma can be very severe, and the lack of a proper reversal agent further endangers a patient’s health whenever this kind of accidents do happen. Other forms of hidden bleeding can also happen under the skin or scalp, manifesting themselves as small blisters or unusual skin folding. Patients under treatment with this blood thinner should always be wary of sports injuries and other forms of internal bleeding including:

  • Bruises
  • Falling
  • Blunt trauma
  • Joint pain
  • Back Pain
  • Legs or abdominal pain
  • Unusually dry skin
  • Blisters or Skin folding
  • Blood in the urines

Sudden stop increases the risk of blood clots

Although this drug is used to prevent blood clots from forming (thrombosis), an increased risk of thromboembolic events can be the consequence of treatment discontinuation. If a patient suddenly stops treatment with rivaroxaban, there is a substantial risk of a blood clot forming inside his vessels. A blood clot traveling to the brain or lungs can cause major damage such as an embolism, and its complications may lead to paralysis or even be lethal. Due to the “once daily” dosage, there’s no way to reduce or adjust the actual dose taken by a patient. Whenever a new contraindication during therapy comes out, there’s no proper way to taper down the dosage slowly. In the event of a sudden mandatory stop in treatment, such as in the occasion of a bleeding accident, the patient’s health may be significantly endangered.

Is stopping Xarelto dangerous?

Temporary interruptions of therapy are quite frequent during anticoagulation therapy, especially in patients who suffer from in atrial fibrillation (one of the main indications of this drug). However, discontinuation of treatment with oral blood thinners is linked with a substantial risk of stroke, blood clots, and bleeding accidents. Patients should never stop taking this drug without informing their doctor, and they should be closely monitored to avoid the risk of further complications.

A study published in the Journal of the American College of Cardiology showed that Xarelto increases the risk of blood clots formation by the same amount Warfarin does, proving that the newer drug is not safer than the old one. The risk of blood clots and thromboembolic events may rise by up to 3 times during the first three months after treatment is suspended, then gradually falls during the next six months.

Wound infections and surgical complications caused by Xarelto

Wound leakage, infections, and increased return-to-surgery rates are all consequences of the use of this drug in hospitalized patients. One of the indications of this medication is the prophylaxis of deep vein thrombosis (DVT) after orthopedic surgery, such as hip or knee replacement. However, some recent researches published in the Journal of Bone & Joint Surgery suggested that this drug may be linked to an increased risk of complications. Since the drug dosage cannot be adequately adjusted to the patient’s need, its anticoagulation properties are often excessively effective, leading to ruptures, wound oozing and drainage, and the formation of blood pools called hematomas. A prolonged drainage may require longer hospitalization as well as the risk of chronic pain and further adverse reactions that may lead to reintervention. The study also showed that many patients had to return to the operating room to receive additional surgery due to an increased rate of wound infections. There are many other alternatives available to physicians to prevent blood clots after orthopedic surgery, ranging from aspirin and low-molecular-weight heparins, to non-pharmacological solutions such as physical rehabilitation and compression stockings.

Spontaneous Spinal Hematoma

One of the most dangerous complications during treatment with this medication is the risk of spontaneous spinal epidural hematoma in patients undergoing spinal puncture or receiving neuraxial anesthesia. The drug’s label includes a special black box warning to alert patients about this terrible adverse reaction. Epidural hematomas occurred in patients treated with this blood thinner may result in permanent or long-term paralysis. Doctors must consider this risk before scheduling a patient to general anesthesia or spinal procedures. It should also be noted how the risk for this type of blood pooling is further increased by just a contemporary treatment with common NSAIDs

What is a Spontaneous Spinal Epidural Hematoma (SSEH)?

Spontaneous spinal epidural hematoma (SSEH) is a somewhat uncommon condition that may severely threaten a patient’s health. It is a large pool of blood leaked from blood vessels (hematoma) that exert pressure on nearby tissues. It usually presents itself as sudden neck or back pain that will eventually cause a general paresis of the limbs. The spontaneous development of epidural hematomas is usually associated with the use of blood thinners such as this one. However, while other anticoagulants therapy can be suspended before the surgical procedure, sudden discontinuation of this drug may endanger a patient’s health. On the other hand, once a patient is affected by spinal hematoma, there’s not much that doctors could do to save his life or prevent paralysis. The management strategies to treat this condition are still unknown, as no evidence-based guidelines are available, forcing physicians to treat this dangerous adverse reaction empirically.

Minor side effects of Xarelto

Even lesser issues need to be mentioned, as a patient’s quality of life is an important factor that needs to be taken into consideration for long-term treatments. Subjects who take this drug need to take it for several months, if not for their entire life. Minor problems such as hair loss or dry skin can be very detrimental to his or her quality of life on the long run. Minor adverse reactions include:

Article written by: Dr. Claudio Butticè, Pharm.D. and designed by Luke Kist

Page Sources and References

  • Hair loss
  • Dry skin
  • Back and joint pain
  • Diarrhea
  • Leg cramps
  • Weakness and fatigue
  • Dizziness
  • Fever and chills
  • Headaches
  • Bladder dysfunctions

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