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History of Xarelto

History Of Xarelto

  • In September 2008, Health Canada granted marketing authorization for rivaroxaban for the prevention of venous thromboembolism (VTE) in people who have undergone elective total hip replacement or total knee replacement surgery.[5]
  • In September 2008, the European Commission granted marketing authorization of rivaroxaban for the prevention of venous thromboembolism in adultss undergoing elective hip and knee replacement surgery.[6]
  • On July 1, 2011, the U.S. Food and Drug Administration (FDA) approved rivaroxaban for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery.[3]
  • On November 4, 2011, the U.S. FDA approved rivaroxaban for stroke prophylaxis in patients with non-valvular atrial fibrillation.

         FDA Warnings

  • Xarelto (Rivaroxaban) Tablets Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
  • March 2014
  • BOXED WARNING optimal timing between the administration of XARELTO and neuraxial procedures is not known WARNINGS AND PRECAUTIONS Spinal/Epidural Anesthesia or Puncture 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.
  • February 2014
  • Summary View
  • 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.”January 2014
  • Summary View
  • 5 WARNINGS AND PRECAUTIONS 5.2 Risk of Bleeding Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue ….. Reversal of Anticoagulant Effect:
  • A specific antidote for rivaroxaban is not available. Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable [see Clinical Pharmacology (12.3)]. Protamine sulfate and vitamin K are not expected ……The use of other procoagulant reversal agents like activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa) has not been evaluated. 5.6 Use with P-gp and Strong CYP3A4 Inhibitors or Inducers Avoid concomitant use of XARELTO with combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir, and conivaptan) [see Drug Interactions (7.1)]. Avoid concomitant use of XARELTO with drugs that are combined P-gp and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort) [see Drug Interactions (7.2)]. 5.8 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. 5.9 Acute PE in Hemodynamically Unstable Patients or Patients Who Require Thrombolysis or Pulmonary Embolectomy Initiation of XARELTO is not recommended acutely as an alternative to unfractionated heparin in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
  • August 2013
  • Summary View
  • BOXED WARNING Premature discontinuation of Xarelto increases the risk of thrombotic events, and spinal/epidural hematoma… 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.MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Safety Alerts for Human Medical Products Drug Safety Labeling Changes Resources for You Xarelto (rivaroxaban) Tablets Prescribing Information, December 2014
 

Xarelto Lawyers Accepting Cases In

Auburn AL; Birmingham AL; Dothan AL; Gadsden AL; Huntsville AL; Mobile AL; Montgomery AL; Muscle Shoals AL; Tuscaloosa AL; Anchorage AK; Fairbanks AK; Juneau AK; Flagstaff AZ; Sedona AZ; Mohave County AZ; Phoenix AZ; Prescott AZ; Show Low AZ; Sierra Vista AZ; Tucson AZ; Yuma AZ; Fayetteville AR; Fort Smith AR; Jonesboro AR; Little Rock AR; Bakersfield CA; Chico CA; Fresno CA; Humboldt County CA; Inland Empire CA; Long Beach CA; Los Angeles CA; Mendocino (new) CA; Merced CA; Modesto CA; Monterey CA; O.C. CA; Oakland CA; Palm Springs CA; Palmdale CA; Redding CA; Sacramento CA; San Diego CA; San Fernando Valley CA; San Francisco CA; San Gabriel Valley CA; San Jose CA; San Luis Obispo CA; San Mateo CA; Santa Barbara CA; Santa Cruz CA; Santa Maria CA; Siskiyou CA; Stockton CA; Susanville CA; Ventura CA; Visalia CA; Boulder CO; CO Springs CO; Denver CO; Fort Collins CO; Pueblo CO; Rockies CO; Western Slope CO; Eastern CT CT; Hartford CT; New Haven CT; Northwest CT CT; Wilmington DE; Dover DE; Newark DE; Pike Creek DE; Bear DE; Washington D.C. District of Columbia; Daytona FL; Fort Myers FL; Ft Lauderdale FL; Gainesville FL; Jacksonville FL; Keys FL; Lakeland FL; Miami FL; Ocala FL; Orlando FL; Panama City FL; Pensacola FL; Sarasota FL; Space Coast FL; St. Augustine FL; Tallahassee FL; Tampa FL; Treasure Coast FL; West Palm Beach FL; Albany GA; Athens GA; Atlanta GA; Augusta GA; Brunswick GA; Columbus GA; Macon GA; Northwest GA GA; Savannah GA; Statesboro GA; Valdosta GA; Big Island HI; Honolulu HI; Kauai HI; Maui HI; Boise ID; East ID ID; Lewiston ID; Twin Falls ID; Bloomington IL; Carbondale IL; Chambana IL; Chicago IL; Decatur IL; La Salle County IL; Mattoon IL; Peoria IL; Rockford IL; Springfield IL; Western IL IL; Bloomington IN; Evansville IN; Ft Wayne IN; INpolis IN; Kokomo IN; Lafayette IN; Muncie IN; Richmond IN; South Bend IN; Terre Haute IN; Cedar Rapids IA; Des Moines IA; Dubuque IA; Fort Dodge IA; IA City IA; Mason City IA; Ottumwa IA; Quad Cities IA; Sioux City IA; Waterloo IA; Lawrence KS; Manhattan KS; Topeka KS; Wichita KS; Bowling Green KY; Eastern KY KY; Lexington KY; Louisville KY; Owensboro KY; Western KY KY; Baton Rouge LA; Lafayette LA; Lake Charles LA; Monroe LA; New Orleans LA; Shreveport LA; Portland ME; Lewiston ME; Bangor ME; West Scarborough ME; Annapolis MD; Baltimore MD; Cumberland Valley MD; Eastern Shore MD; Frederick MD; Western MD MD; Boston Massachusetts; Cape Cod Massachusetts; South Coast Massachusetts; Springfield Massachusetts; Worcester Massachusetts; Ann Arbor MI; Battle Creek MI; Central MI MI; Detroit MI; Flint MI; Grand Rapids MI; Holland MI; Jackson MI; Kalamazoo MI; Lansing MI; Monroe MI; Muskegon MI; Northern MI MI; Port Huron MI; Saginaw MI; Southwest MI MI; Upper Peninsula MI; Duluth MN; Mankato MN; Minneapolis MN; St Paul MN; Rochester MN; St. Cloud MN; Biloxi MS; Hattiesburg MS; Jackson MS; Meridian MS; Natchez MS; North MS MS; Columbia/Jeff City MO; Joplin MO; Kansas City MO; Kirksville MO; Lake of the Ozarks MO; Southeast MO MO; Springfield MO; St. Joseph MO; St. Louis MO; Billings MT; Missoula MT; Great Falls MT; Bozeman MT; Butte MT; Grand Island NE; Lincoln NE; North Platte NE; Omaha NE; Scottsbluff NE; Las Vegas NV; Reno NV; Manchester NH; Nashua NH; East Concord NH; Concord NH; Derry Village NH; Central Jersey NJ; Jersey Shore NJ; North Jersey NJ; South Jersey NJ; Albuquerque New Mexico; Santa Fe New Mexico; Albany NY; Binghamton NY; Buffalo NY; Catskills NY; Chautauqua NY; Elmira NY; Finger Lakes NY; Glens Falls NY; Hudson Valley NY; Ithaca NY; Long Island NY; New York City NY; Oneonta NY; Plattsburgh NY; Potsdam NY; Rochester NY; Syracuse NY; Twin Tiers NY; Utica NY; Watertown NY; Westchester NY; Asheville NC; Boone NC; Charlotte NC; Eastern NC; Fayetteville NC; Greensboro NC; Hickory NC; Outer Banks NC; Raleigh NC; Wilmington NC; Winston Salem NC; Fargo ND; Akron OH; Canton OH; Ashtabula OH; Athens OH; Chillicothe OH; Cincinnati OH; Cleveland OH; Columbus OH; Dayton OH; Huntington/Ashland OH; Lima/Findlay OH; Mansfield OH; Sandusky OH; Toledo OH; Tuscarawas County OH; Youngstown OH; Zanesville/Cambridge OH; Lawton OK; OK City OK; Stillwater OK; Tulsa OK; Bend OR; Corvallis OR; East OR OR; Eugene OR; Medford OR; OR Coast OR; Portland OR; Roseburg OR; Salem OR; Allentown PA; Altoona PA; Cumberland Valley PA; Erie PA; Harrisburg PA; Lancaster PA; Meadville PA; Philadelphia PA; Pittsburgh PA; Poconos PA; Reading PA; Scranton PA; State College PA; Williamsport PA; York PA; Providence RI; Warwick RI; Cranston RI; Pawtucket RI; East Providence RI; Woonsocket RI; Charleston SC; Columbia SC; Florence SC; Greenville SC; Hilton Head SC; Myrtle Beach SC; Sioux Falls SD; Rapid City SD; Aberdeen SD; Chattanooga TN; Knoxville TN; Memphis TN; Nashville TN; Tri-cities TN; Abilene TX; Amarillo TX; Austin TX; Beaumont TX; Brownsville TX; College Station TX; Corpus Christi TX; Dallas TX; Denton TX; El Paso TX; Fort Worth TX; Galveston TX; Houston TX; Huntsville TX; Killeen TX; Laredo TX; Lubbock TX; Mcallen TX; Odessa TX; San Antonio TX; San Marcos TX; Texarkana TX; Texoma TX; Tyler TX; Victoria TX; Waco TX; Wichita Falls TX; Logan UT; Ogden UT; Provo UT; Salt Lake City UT; St. George UT; Burlington VT; Essex Junction VT; Bennington VT; Charlottesville VA; Chesapeake VA; Danville VA; Fredericksburg VA; Hampton VA; Harrisonburg VA; Lynchburg VA; New River Valley VA; Newport News VA; Norfolk VA; Portsmouth VA; Richmond VA; Roanoke VA; SouthWV VA; Suffolk VA; VA Beach VA; Bellingham WA; Everett WA; Moses Lake WA; Olympia WA; Pullman WA; Seattle WA; Spokane WA; Tacoma WA; Tri-cities WA; Wenatchee WA; Yakima WA; Charleston WV; Huntington WV; Martinsburg WV; Morgantown WV; Parkersburg WV; Southern WV WV; Wheeling WV; Appleton WI; Eau Claire WI; Green Bay WI; Janesville WI; La Crosse WI; Madison WI; Milwaukee WI; Racine WI; Sheboygan WI; Wausau WI; Cheyenne WY; Casper WY; Laramie WY; Gillette WY;