Xarelto Rebound Strokes

Discussion in 'Janssen' started by Anonymous, Sep 27, 2012 at 8:21 AM.

Tags: Add Tags
  1. Anonymous

    Anonymous Guest

    So read your PI how do you bridge off your product oh wait no information. And to your point the docs in your study didn't understand bridging? That is the problem you can't bridge off your product hence the rebound strokes. Its why you have a black box warning.
     

  2. Anonymous

    Anonymous Guest

    go get 'em tiger! bwahahaha!!!
     
  3. Anonymous

    Anonymous Guest

    You tell me, douche:

    Jansen Pharmaceuticals’ new anticoagulant drug Xarelto (generic: rivaroxaban) has recently been linked to internal bleeding and other serious side effects. While Xarelto has been shown to require less intensive monitoring than its major competitor Coumadin (generic: warfarin), reports have shown that it may result in serious internal bleeding events that could be extremely difficult to treat. Signs and symptoms of Xarelto-induced internal bleeding may include blood in the urine or stools, vomiting blood, and any unusual bleeding.

    Free Xarelto Lawsuit Evaluation: If you or a loved one has been diagnosed with internal bleeding after being treated with Xarelto, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Xarelto and we can help.
    What’s the problem with Xarelto?

    Manufactured and marketed by Jansen Pharmaceuticals, Xarelto is an anticoagulant blood thinner designed to prevent the formation of blood clots. Xarelto was approved by the U.S. Food & Drug Administration (FDA) in July 2011 for the prevention of a type of blood clot known as deep vein thrombosis (DVT), a condition that commonly occurs after certain types of surgeries. The drug is also commonly prescribed to reduce the risk of stroke in patients with a certain type of heart rhythm disorder. Xarelto belongs to a class of drugs known as factor Xa inhibitors, which includes the much-troubled Pradaxa (generic: dabigatran).
    Xarelto & Internal Bleeding

    Unfortunately, Xarelto has been linked to an increased risk for internal bleeding events. Signs and symptoms of Xarelto-induced internal bleeding may vary, depending on the location of the bleeding, and what body functions are affected. Symptoms of internal bleeding may include:

    unusual bleeding
    discolored urine (blood in the urine)
    red or black-colored stool
    coughing up blood
    vomiting blood that looks like coffee grounds
    frequent nose bleed or gum bleeding
    weakness and swelling in the extremities

    According to a new study conducted by researchers in Australia, Xarelto presents less of a risk of bleeding in the brain than Coumadin (warfarin) when given to patients with atrial fibrillation, but like Pradaxa, Xarelto may cause more serious bleeding events that could be difficult to treat. The FDA has announced that it is currently in the process of evaluating bleeding events in patients being treated with Xarelto to determine whether the risks outweigh the benefits of the drug.
    Xarelto Side Effects

    In addition to having the potential to cause serious internal bleeding events, Xarelto has also been associated with a number of less severe side effects such as:

    severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
    bloody or black, tarry stools
    coughing up blood
    dark urine
    fever
    chills
    sore throat
    pain or new drainage at wound sites
    pink or red urine
    red, swollen, blistered, or peeling skin
    stiff, sore, hot, or painful joint
    symptoms of anemia (e.g., unusual paleness, severe or persistent headache, shortness of breath, fast heartbeat, chest pain, unusual tiredness or weakness)
    symptoms of bleeding in the brain (e.g., sudden, severe headache; one-sided weakness; vision problems; slurred speech; confusion)
    symptoms of low blood pressure (e.g., fainting, light-headedness, severe or persistent dizziness)
    unexplained swelling
    unusual or prolonged bruising or bleeding
    vomit that looks like coffee grounds
    yellowing of the skin or eyes (jaundice)

    Xarelto & Pregnancy

    The FDA currently classifies Xarelto in Pregnancy Category C, which means that it is not known whether the drug will cause harm to an unborn baby. However, Xarelto has the potential to cause bleeding complications during childbirth. If you are currently taking Xarelto, consult your doctor immediately if you become pregnant. Additionally, it is not known whether Xarelto has the ability to pass into breast milk, or if it could cause harm to a nursing baby. The FDA has advised women who are breastfeeding not to initiate treatment with Xarelto.
    Do You Have a Xarelto Lawsuit?

    The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Xarelto lawsuits. We are handling individual litigation nationwide and currently accepting new internal bleeding cases in all 50 states.

    Free Xarelto Lawsuit Evaluation: If you or a loved one has suffered from an internal bleeding event after being treated with Xarelto, you should contact our law firm immediately. You may be entitled to compensation by filing a Xarelto internal bleeding suit and we can help.
    Related Content on our Website



    Attention Attorneys: Schmidt & Clark considers a referral from another law firm to be one of the greatest compliments. Our law firm has built a reputation for success and accepts a number of case referrals on a regular basis. We do not publish prior verdicts or settlements on our website. If you would like to refer us a case or for us to send you a profile of prior award judgments or average referral fees, please visit the attorney referral section of our website.
     
  4. Anonymous

    Anonymous Guest

    Point 1: Pradaxa needs no bridge when you discontinue. So your first sentence is rubbish.

    Point 2: Yes, the "misnomer of rebound" ONLY occurred with Xarelto (That's why you are the ONLY one with a black box warning the docs for this "misnomer of rebound")

    Point 3:When a patient discontinues Pradaxa and goes to warfarin NO additional stokes were noticed, that's why they have NO black box warning.

    Point 4: The Zarelto black box is about switching from one product to another product NOT about switch OFF a product to NO product. So your last statement is also rubbish.

    Point 5: Your logic has more holes than an excellent aged Jahrlesberg Swiss Cheese, and we Germans know our cheeses too.
     
  5. Anonymous

    Anonymous Guest

    So how do you switch Zarelto to Coumadin, what's the protocal? How long before I can check my INR once I've switched. Should I start a loading Coumadin dose of 5mg or lower since Zarelto may still be present. Should I stagger the start of coumadin before I fully DC my Zarelto or only take after I have fully DC/ed my Zarelto.

    Please Help answer my questions I am worried about the massive GI bleeds your drug showed in the ROCKET AF trial and I am really worried. Only legitimate replies pleaese, I have a patient's life in your hands and really need your help. None of those questions are answered in the PI and I guess you would know these answers for me.

    .......



    Well, I'm waiting?

    .............





    Oh, that's what I thought. Now end this thread before even more of your JnJ'ers look even more stupid.
     
  6. Anonymous

    Anonymous Guest

    Are you serious??? JnJ'ers look stupid?? You can't even spell Xarelto correctly, your post really exposes just how uniformed you are on the subject matter beyond just the spelling:

    "Massive" GI bleeds? warfarin140; Xarelto 221; hardly considered massive my friend

    PI CLEARLY states:
    discontinue Xarelto and begin both parenteral anticoagulant and warfarin at the time the next dose of Xarelto would have been taken...

    Obviously warfarin takes up to 5 days to get within therapeutic range, so you'd need to bridge, this is AC 101!! Doctors have a CLEAR understanding of this and are comfortable with this information.

    I won't even get into bashing your drug...way too easy my friend, just thought you needed some eduction...
     
  7. Anonymous

    Anonymous Guest

    How do you measure it with an INR? Not possible also if its so easy why do you have a black box warning for rebound strokes again you are putting patients at higher risk when they have to stop taking this product.
     
  8. Anonymous

    Anonymous Guest

    Hey Sparky, Anticoagulatiion 101....to your Point 1.....newsflash, it's not the Pradaxa or the Xarelto that dictates the need for bridging.....HELLOOOOO, it's the Coumadin!!!!!! you see, it takes Coumadin a while to become therapeutic and THAT is why you need to bridge. That statement didn't show up in your package insert because.....HELLOOOOO....your trial didn't follow patients for 30 DAYS after being taken OFF the medication. To your Point 3....this is hysterical that you would make this statement because in your trial, you didn't switch pts. to warfarin THEREFORE, YOU DO NOT KNOW THIS TO BE TRUE !!!!!!!!!!!!!!!!!!!!!!

    You are obviously new to anticoagulation AND cardilogy. You know nothing about anticoagulation and you have no idea how smart cardiologists are, if you did, you would not be saying these things to them. I promise they are laughing and shaking their heads at you. I just hope all of the BI reps are this misinformed.
     
  9. Anonymous

    Anonymous Guest

    ps. your own company, at a speaker training meeting, told your speakers that they didn't believe that the strokes seen at the end of ROCKET where "rebound" strokes. The strokes happened because the Coumadin was not therapeutic. One of your speakers told me this while sitting in his office.
     
  10. Anonymous

    Anonymous Guest

    You can't taken an INR on transition for 2 weeks so could be subtherapeutic on coumadin or it's something about the drug, or the half-life. How the eff' do I know nor do I care. Maybe that's why we feel it's scary.
     
  11. Anonymous

    Anonymous Guest

    Ummm, yes, Coumadin needs bridging NOT Pradaxa or Zarelto, but this bridging is ONLY used with transitioning Zarelto NOT Pradaxa.

    You seriously can't be this dense.
     
  12. Anonymous

    Anonymous Guest

    Has anyone else gone to www johnson and toxin .com? Nice company
     
  13. Anonymous

    Anonymous Guest

    Blah blah blahdy fuckin' blah, the anticoagulant with all the baggage is dapigatran, brand name Probleeda:

    http://www.fiercepharma.com/story/pradaxa-leads-fda-medwatch-list-fatalities/2012-06-06
     
  14. Anonymous

    Anonymous Guest

  15. Anonymous

    Anonymous Guest

    This is like watching 2 nerds fight in the library. Knock his glasses off!
     
  16. Anonymous

    Anonymous Guest

    Yeah, if I'm a physician who's not competent to practice I'll join the medical equivalent of the Occupy Movement and send a letter. Ooooooh! Scary! Sydney Wolfe is a long time nutcase who gets no respect, for instance this letter, which made no difference to the FDA. And just to be clear BI douche, it's Pradaxa that is creating a stir with an adverse event and mortality profile that is significantly worse than that seen in RELY.
     
  17. Anonymous

    Anonymous Guest

    I give up. We're dealing with a thick one here
     
  18. Anonymous

    Anonymous Guest

    The post-release data is not inconsistent with the RELY trial. See the EMA article for even extra info on the EU side before you pull random bullshit out your ass.
     
  19. Anonymous

    Anonymous Guest

  20. Anonymous

    Anonymous Guest