Safety Alerts & Recalls

Alerts for Dabigatran

Title Date Published Source
FDA Completes Study Reviewing Efficacy and Safety of Pradaxa® (dabigatran) 2014-05-14
Los Profesionales de la Salud Informados Sobre los Factores de Riesgo de Sangrado con Eliquis, Pradaxa y Xarelto 2013-10-25
Healthcare Professionals Advised About Risk Factors for Bleeding with Eliquis, Pradaxa and Xarelto 2013-10-11
New Blood Thinners Now Available on the PBS 2013-09-25
Dabigatran Should Not Be Used in Those With Prosthetic Heart Valves 2013-08-08
Patient Risk Assessment Needed For Prescribing Dabigatran 2013-05-30
Healthcare Professionals Advised Not to Use Pradaxa in Patients With Prosthetic Heart Valves 2013-04-25
Updated Safety Warning Advice for Pradaxa 2013-02-11
Boehringer Ingelheim informiert Ärzte, dass Pradaxa (Dabigatran) nicht bei Patienten mit künstlichen Herzklappen eingesetzt werden darf 2013-01-11
Pradaxa Contraindicated in Patients With Mechanical Heart Valves 2012-12-20
Boehringer Ingelheim Recalls Single Lot of Pradaxa 75 mg Capsules 2012-11-15
FDA Reports Bleeding Risk With Pradaxa Similar to Warfarin 2012-11-06
Healthcare Professional Advised of the Updated Safety Warnings for Pradaxa 2012-08-15
L’EMA fait une mise à jour sur le risque hémorragique du Pradaxa (dabigatran) 2012-05-31
La EMA Actualiza la Información de Pradaxa Para Médicos y Pacientes 2012-05-31
L’AFFSAPS fait un point sur les nouveaux anticoagulants oraux utilisés chez les patients avec une fibrillation auriculaire 2012-05-02
New Study Study Finds Small Increased Risk of Heart Attack in Patients Treated with Pradaxa 2012-01-13
FDA Evaluating Reports of Bleeding in Patients Taking Pradaxa 2011-12-08
Dabigatran (Pradaxa): New Recommendations for Monitoring Kidney Function 2011-11-09
Healthcare Professionals Advised Not to Use Pradaxa in Patients With Impaired Kidney Function 2011-11-08
Boehringer Ingelheim informiert Ärzte über neue Vorsichtsmaßnahmen für das gerinnungshemmende Medikament Pradaxa (Dabigatran) 2011-11-02
La AEMPS Recomienda Evaluar La Función De Los Riñones Con Pradaxa (Dabigatrán) Debido A Un Aumento En El Riesgo De Sangrado 2011-11-02
TGA Warns of Risk of Bleeding Relating to Use of Pradaxa 2011-10-10
FDA Issues Safety Alert: Special Storage and Handling Requirements Must Be Followed for Pradaxa (Dabigatran Etexilate Mesylate) Capsules 2011-03-30
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