Tag: Pradaxa
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Pradaxa Side Effects Update Mid-2012: Deaths, Hemorrhages, Acute Renal Failure, and Stroke Events Submitted To FDA MedWatch
Medical Journal Article Reports Pradaxa-Induced Rectal Bleeding And Hemostatic Disorder In Two Elderly Patients (Posted by Tom Lamb at DrugInjuryWatch.com) On May 31, 2012 the Institute for Safe Medication Practices (ISMP) released its 2011…
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Safety Developments Regarding Pradaxa: Boehringer Starts Drug Registry; EMA Wants Label Change; Study Compares Pradaxa Use To Coumadin As Regards Side Effects
Pradaxa Adverse Reactions And Serious Bleeding Events More Common In Older Patients And Females, With Reduced Renal Function Also Being A Factor (Posted by Tom Lamb at DrugInjuryWatch.com) In April 2012 the manufacturer of…
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Pradaxa Noted For Possible Heart Attack Risk In Addition To Serious Gastrointestinal Bleeding And Other Hemorrhages
Recent Medical Article And Poster Presentation Both Point To A Trend Toward Increased Rate Or Risk Of Myocardial Infarction (MI) (Posted by Tom Lamb at DrugInjuryWatch.com) A recent "position paper" by a group of…
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Pradaxa Hemorrhage Cases May Occur In Oldest Patients Due To Age-Related Decline In Renal Function
QuarterWatch 2011 Quarter 2: More Pradaxa Adverse Events Reported Than Any Other Regularly Monitored Drug (Posted by Tom Lamb at DrugInjuryWatch.com) The developing drug safety controversy involving the anticoagulation drug Pradaxa (dabigatran) has been…
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Focus on Pradaxa Pradaxa® is the name under which Boehringer Ingelheim Pharmaceuticals, Inc. markets a prescription anticoagulant medication generically called dabigatran. _______________________________________________________________________________ Free Pradaxa Case Evaluation The information you provide to us for…
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Pradaxa: 2012 Label Revisions In The U.S. And Canada, Where A “Dear Doctor” Letter Was Sent Out
New Case Report About Routine Fall Involving An Elderly Patient That Results In Fatal Irreversible Brain Hemorrhage (Posted by Tom Lamb at DrugInjuryWatch.com) Pradaxa® is the name under which Boehringer Ingelheim Pharmaceuticals, Inc. markets a prescription…
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Pradaxa Bleeding Events: Four Major Factors Which Contributed To These Serious Side Effects
Prescriber Error, Impaired Renal Function, Patient Age, And Lack Of An Effective Reversal Agent Are Cited (Posted by Tom Lamb at DrugInjuryWatch.com) A Letter to The Editor, titled "Bleeding Risk with Dabigatran in the Frail…
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Pradaxa: Excess Number Of Severe Bleeding Events In Certain Patient Populations And Settings
At Increased Risk Are Patients Who Are Older, Have Altered Renal Clearance, Or Undergoing Atrial Fibrillation (AF) Ablation (Posted by Tom Lamb at DrugInjuryWatch.com) We first reported about Pradaxa (dabigatran) back in October 2011 in this…
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Safety Profile Of New Stroke Drug Pradaxa Has Been Tarnished By Various Adverse Event Reports
FDA Reviewing Serious Side Effects Associated With Pradaxa Ranging From Heart Attacks To Serious Bleeding or Hemorrhages (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: Pradaxa label change: This January 17, 2012 FDA approval letter shows…
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Pradaxa: FDA Investigating Possible Higher Than Expected Incident Rate Of Serious Bleeding Side Effects
Adverse Event Reports For This New Blood Thinner Drug May Exceed Pre-Approval Clinical Trial Observations (Posted by Tom Lamb at DrugInjuryWatch.com) In early December 2011 the FDA announced it is evaluating reports of bleeding in…