Tag: serious bleeding
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FDA Drug Safety Concerns About Pradaxa And Serious Bleeding Side Effects Will Get Another Look By Means Of New 2014 Study
A Primary Focus Is Gastrointestinal And Intracranial Hemorrhages In Patients Using Pradaxa For Atrial Fibrillation (Posted by Tom Lamb at DrugInjuryWatch.com)Pradaxa, an anticoagulant drug from Boehringer Ingelheim, was approved by drug regulators in Europe…
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Pradaxa Adverse Drug Events (ADEs) Result In Death More Often Than Other Anticoagulants / Blood Thinners ADE Reports
Again In 2012, Pradaxa (Dabigatran) Had Dubious Distinction Of Being Ranked First For Direct FDA Reports Of Adverse Events (Posted by Tom Lamb at DrugInjuryWatch.com) The October 2013 edition of ISMP QuarterWatch, Data from 2012…
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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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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…