Category: Side Effect: Bleeding Events (hemorrhage, overanticoagulation)
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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…
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New Heart Drug Pradaxa May Be Sending “Early” Drug Safety Signals
ISMP QuarterWatch 2010 4th Quarter: Hemorrhages And Thromboembolic Events Have Been Reported To FDA (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "Boehringer says about 260 deaths related to Pradaxa" (11/12/11, Reuters) FRANKFURT Nov 12…