Xarelto Safety Precautions

The main risk associated with Xarelto (rivaroxaban) is uncontrolled bleeding, so employing some effective safety precautions is of paramount importance for all patients taking this medication. If you are taking this drug to treat or prevent conditions such as Atrial Fibrillation (AFib), Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), or as a prophylaxis against stroke and blood clots, you should be adequately warned about the risks associated with this medication. Depending on what your condition is, you may need to take this drug for a defined period (usually for 2-6 weeks) or indefinitely for the rest of your life. Always read through the drug label information to know all the side effects and contraindications of this medication, and check with your doctor or pharmacist in case of any side effect or adverse reaction.

However, a few simple precautions can go a long way in minimizing the risks associated with this medication, such as the life-threatening uncontrolled bleeding, hemorrhoids, gum bleeding, and gastrointestinal or internal hemorrhages. All patients should be wary about even the smallest bleeding: the lack of a proper reversal method (antidote) could transform even a simple knife cut into a hemorrhage, requiring emergency intervention. This guide will provide you some basic information on how to reduce the risk of transforming a minor trauma into a deadly accident.

xarelto side effects

 

Basic Safety

Some simple basic tips can go a long way in reducing the risk of bleeding accidents. This section includes mostly simple bits of advice and common Xarelto bleeding precautions you should employ during day-to-day activities. Even the simplest safety measure may save you from an emergency room rush!

  • Don’t be ashamed to ask for help. People like your family, friends and caregivers can provide invaluable help and support during your treatment. You can also find seek online resources such as support groups and forums to find additional advice or just share and read other patients’ stories.
  • Always double-check your daily dose with the help of a diary or personal organizer. If you missed a dose, take it as soon as possible on the same day. On the next day, however, do not change your schedule and take the next dose as usual. If you are not sure, however, always check with your doctor. Doubling a dose is usually more dangerous than missing a single pill.
  • Try to avoid excess physical exertion, sports or other activities that may put you at risk for traumas and injuries such as football or martial arts. Even a mild blunt trauma like a fall may cause a harmful internal bleeding.
  • Protect your hands and arms by wearing gloves or other similar protections when using sharp utensils such as knives, scissors, razors or gardening tools.
  • Try to reduce the risk of bleeding gums by using toothbrushes with soft bristles and waxed floss.
  • Always check your doctor’s advice before taking any other medication, including over-the-counter drugs. Xarelto interactions include several medications such as NSAIDs, antibiotics, and herbal remedies.
  • Tell your dentist or doctor that you are under treatment with this blood thinner before undergoing any dental or medical surgery or procedure.
  • Carefully chew any crisp or crunchy food (such as an almond or peanut brittle) to reduce the risk of gum bleeding.
  • Try to avoid or, at least, limit your alcohol consumption, as it may increase the risk of gastrointestinal bleeding and ulcers, as well as falling and driving accidents.
  • Use an electric razor when shaving and pay great attention when clipping your tools with sharp objects.

 

Warnings And Dangers

Other than simple bleeding precautions tips, it is of the utmost importance to know how to avoid the more dangerous risks. Rivaroxaban is, in fact, a potentially harmful medication. Because of that, FDA issued a specific black label to warn patients about its dangers. You should always read carefully the medicine’s label, and talk with your doctor or pharmacist whenever you’re in doubt or find something that’s not clear.

  • Do not stop taking this drug without talking with your doctor. Sudden treatment discontinuation may increase the risk for blood clots threefold.
  • This blood thinner can increase the risk of Epidural or Spinal Hematomas when a patient undergoes spinal procedures (such as spinal puncture or surgery) and spinal anesthesia (such as epidural). Always talk with your surgeon or specialist about the risk of such procedures while under treatment with this anticoagulant. Epidural and Spinal Hematomas may lead to long-term or permanent paralysis.
  • This anticoagulant is contraindicated if you suffer from several conditions (described below). Always talk to your doctor about your current conditions before taking this medication.
  • Rivaroxaban may interact with several drugs and herbal remedies, including over-the-counter medications such as NSAIDs. Always talk with your pharmacist or general practitioner before taking any other medication. We included a brief recap of some major drug interactions below.
  • Always talk with your doctor after a fall or injury. Even a simple bruise may cause a hidden bleeding which may require emergency treatment.
  • Do not take Xarelto if you are allergic to Rivaroxaban.
  • This medication is not safe during pregnancy because the risk of birth defects has never been ruled out (FDA Category C). Xarelto should not be used during pregnancy or if you’re planning to get pregnant, and during breastfeeding.
  • Xarelto is not recommended in patients with prosthetic heart valves because its safety has never been properly evaluated in such circumstances.

 

Contraindications

This blood thinner is contraindicated whenever a patient suffers from one of the conditions described below. Always check with your doctor whenever one of these conditions present even later during treatment.

  • Hemophilia
  • Anemia
  • Thrombocytopenia
  • Liver Disease
  • Kidney Disease
  • Gastrointestinal Bleeding
  • Brain Bleeding and Stroke
  • Nonvalvular Atrial Fibrillation
  • Recent Major Surgery or Injury
  • Increased Risk for Falling
  • Retinopathy
  • Lapp Lactase Deficiency
  • Glucose-Galactose Malabsorption
  • Galactose Intolerance

 

Bleeding Symptoms

We are sure that after reading this guide, you will know how to avoid taking unnecessary risks while taking Xarelto. However, even if you have always been careful, accidents may still happen. Here is a list of the most common symptoms you should be alarmed about as they may reveal a hidden bleeding. This does not mean that every time you have a headache you should call 911, but if you suddenly start to feel fatigued without reason, and the headache doesn’t just disappear after a few hours, then you should call your doctor and talk to him about your symptoms.

  • Unusual or Uncontrolled Bleeding
  • Gum Bleeding
  • Hemorrhoidal or Rectal Bleeding
  • Vaginal Bleeding
  • Heavy Menstruation
  • Fatigue
  • Dizziness
  • Weakness
  • Headaches
  • Easy Bruising
  • Back pain
  • Coughing Up Blood or Blood Clots
  • Fainting
  • Red, Brown or Pink Urines (Blood in the Urines)
  • Pain or Swelling from Recent Wounds
  • Pain in the Arms or Legs
  • Abdominal or Back Pain
  • Muscle Weakness
  • Numbness, Tingling or Loss of Movement in Any Part of the Body
  • Black or Bloody Stools
  • Vomiting Blood or Material that Appears as Coffee Grounds
  • Frequent Nosebleeds
  • Difficult Breathing
  • Swelling of Face, Throats or Lips

 

Drug Interactions

Avoiding dangerous drug interactions is one of the most important basic precautions you should always follow. Due to its peculiar mechanism of action, rivaroxaban may, in fact, interact with several other substances including over-the-counter medications and herbal remedies. Although the list of possible interactions is way too long, we only aim at providing the most basic and known Xarelto drug interactions to help you minimize the risks. For a complete list of potential interactions with other medications and substances, you should ask your pharmacist or check the medication’s label.

  • All drugs that may increase the risk of bleeding such as Aspirin and Nonsteroidal Anti-inflammatory Drugs (NSAIDs).
  • Drugs that impair hemostasis (the stoppage of bleeding) such as P2Y12 platelet inhibitors (clopidogrel, prasugrel), anticoagulants (heparins), fibrinolytic therapy, other blood thinners (warfarin), and antithrombotic agents (streptokinase, urokinase).
  • Cytochrome P450 3A4 Inducer drugs (rifampicin, phenytoin), which can reduce the exposure to rivaroxaban, and consequently, reduce its effectiveness.
  • Combined P-gp and moderate CYP3A4 inhibitors (verapamil, ritonavir, ketoconazole, erythromycin), which can increase the exposure to rivaroxaban, and consequently, increase the risk of uncontrolled bleedings.
  • Herbal remedies that may show any one of the above effects such as Ginkgo Biloba or St. John’s wort.

Article written by: Dr. Claudio Butticè, Pharm.D.

 

REFERENCES

  1. FDA U.S. Food and Drug Administration Website: “MEDICATION GUIDE XARELTO® (zah-REL-toe) (rivaroxaban) tablets” Reference ID: 3688029. (Accessed June 2015).
  2. Bleeding with dabigatran, rivaroxaban, apixaban. No antidote, and little clinical experience.” Prescrire Int. 2013 Jun;22(139):155-9.
  3. Institute for Safe Medication Practices (ISMP) “ISMP List of High-Alert Medications in Acute Care Settings” (Accessed June 2015)
  4. Jaeger M, Jeanneret B, Schaeren S. “Spontaneous spinal epidural haematoma during Factor Xa inhibitor treatment (Rivaroxaban).” Eur Spine J. 2012 Jun;21 Suppl 4:S433-5.
  5. Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. “Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.” N Engl J Med. 2011;365(10):883-891.
  6. J P Hanley “Warfarin reversal” J Clin Pathol. 2004 Nov; 57(11): 1132–1139.