Xarelto (rivaroxaban)
FDA Drug Warnings
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01
March
2014
Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research
UPDATED [March 2014] To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban [see Clinical Pharmacology (12.3)]. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.
Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, monitor frequently to detect any signs or symptoms of neurological impairment, such as midline back pain, sensory and motor deficits (numbness, tingling, or weakness in lower limbs), bowel and/or bladder dysfunction. Instruct patients to immediately report if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.
FDA previously released a Drug Safety Communication about the risk of serious bleeding associated with the use of Pradaxa in patients with non-valvular atrial fibrillation (the population for which the drug is approved). FDA has not changed its recommendations regarding use of Pradaxa in the population for which it is approved.
DRUG INTERACTIONS
Study results added… “An Open-Label Study to Estimate the Effect of Multiple Doses of Erythromycin on the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Rivaroxaban in Subjects with Renal Impairment and Normal Renal Function.”
WARNINGS AND PRECAUTIONS
Increased Risk of Thrombotic Events after Premature Discontinuation - Premature discontinuation of any oral anticoagulant, including Xarelto, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events.
Patients with Prosthetic Heart Valves - The safety and efficacy of Xarelto have not been studied in patients with prosthetic heart valves. Therefore, use of Xarelto is not recommended in these patients.
Related Information
How Do I Document My Claim
It will speed up the process if you have the following information available before you contact us:
- Consult your doctor immediately if you suspect an injury. Follow the medical instructions of your doctor or a qualified medical professional.
- Keep a notebook detailing the injuries you or a loved one has suffered, with dates and symptoms documented.
- Keep track of your prescriptions for Xarelto, note the dosage you have taken and the time period over which you took the drug.
- Keep any containers of Xarelto and make a note of the pharmacies where you had your prescriptions filled.
- If possible, document your injuries with pictures or other evidence.
Our firm works on a contingency basis which means you will not be asked to pay any money out of pocket.
This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.
Known Xarelto Side Effects
Xarelto is being marketed as an improvement to tradition anticoagulants such as Warfarin for patients that require frequent blood draws. However, there have already been reports of deaths and other serious life threatening Xarelto side effects reported since Xarelto was approved by the FDA. There has not to date been a Xarelto recall and the FDA nor the makers of Xarelto hinted that there is any reason to have Xarelto recalled.
- Unusual bruising or bleeding
- Red or black tarry stools
- Frequent nose bleeds
- Vomiting that resembles blood or looks like coffee grounds
- Weakness and swelling in the hands, arms, lower legs, ankles or feet
- Joint pain or swelling
- Dizziness
- Death
Xarelto Warnings:
Xarelto has been associated with several severe side effects, including Xarelto internal bleeding. Furthermore, there is currently no antidote available to reverse Xarelto bleeding should it occur.
According to the U.S. Food and Drug Administration (FDA) Adverse Reporting System (FAERS), hemorrhaging, or Xeralto bleeding, is one of the most common side effects of taking Xarelto. Additional severe health conditions associated with the use of Xeralto include:
- thrombosis (blood clots)
- decreased hemoglobin (a substance that carries oxygen in red blood cells)
- cerebrovascular accidents (an event that leads to a stroke, such as a cerebral hemorrhage)
- hematoma (a semisolid mass in the blood)
- peripheral edema (swelling of the lower limbs)
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