Re: Xarelto August 09, 2013 11:12AM |
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Re: Xarelto August 09, 2013 08:02PM |
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Over the past year, I have yet to see a major adverse event with rivaroxaban, and this experience includes cardioversion and AF ablation. I asked around and my colleagues echo the same sentiment. Although early, and I could be wrong, I don’t think this is fluky. Consider that in the Einstein-PE trial, rivaroxaban, albeit at a higher dose, proved to be an effective strategy to treat pulmonary embolus (blood clot in the lung.) This is significant because PE is a disease that requires potent anticoagulation. That rivaroxaban worked so well speaks to its anticoagulant effects.
I talked to a very busy cardiologist as well as my EP about Xarelto risks. Both assured me they had no qualms about it.Quote
FDA Reviewer Slams Xarelto for Stroke Prevention in Afib
Published: Sep 6, 2011
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Despite the overwhelmingly negative tone of the FDA review, there were no new safety issues uncovered, the reviewers said.
In fact, rivaroxaban-treated patients experienced numerically fewer critical organ bleeds, intracranial hemorrhages, hemorrhagic strokes, and fatal bleeds compared with patients treated with warfarin.
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Re: Xarelto August 09, 2013 09:17PM |
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5. WARNINGS AND PRECAUTIONS
Hemorrhage
Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur within the first month. Risk factors for bleeding include high intensity of anticoagulation (INR > 4), age greater than or equal to 65, history of highly variable INRs, history of gastrointestinal bleeding, hypertension, cerebrovascular disease, anemia, malignancy, trauma, renal impairment, certain genetic factors [see Clinical Pharmacology (12.5)], certain concomitant drugs [see Drug Interactions (7)], and long duration of Warfarin therapy.
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6. ADVERSE REACTIONS
The following serious adverse reactions to Warfarin sodium are discussed in greater detail in other sections of the labeling:
Hemorrhage [see Boxed Warning, Warnings and Precautions (5.1), and Overdosage (10)]
Necrosis of skin and other tissues [see Warnings and Precautions (5.2)]
Systemic atheroemboli and cholesterol microemboli [see Warnings and Precautions (5.3)]
Other adverse reactions to Warfarin sodium include:
Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions)
Vascular disorders: vasculitis
Hepatobiliary disorders: hepatitis elevated liver enzymes. Cholestatic hepatitis has been associated with concomitant administration of Warfarin sodium and ticlopidine.
Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating
Skin disorders: rash, dermatitis (including bullous eruptions), pruritus, alopecia
Respiratory disorders: tracheal or tracheobronchial calcification
General disorders: chills
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Re: Xarelto August 10, 2013 10:53PM |
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