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 in 2008 and later by the FDA in 2010.

In recent years personal injury and wrongful death lawsuits have been filed against the drug company in some instances where patients developed certain serious medical conditions while using Pradaxa, such as the following:

•  Serious bleeding side effects such as gastrointestinal (GI) bleeds and rectal bleeding
•  Irreversible life-threatening bleeding events
•  Trauma-induced atypical bleeding incidents due to lack of effective reversal agent
•  Hemorrhages such as brain hemorrhage, intracranial hemorrhage, and hemorrhagic stroke
•  Thromboembolic complications such as cerebrovascular accident (CVA)
•  Death as a result of excessive bleeding

On December 30, 2013 the FDA posted for public comment on a proposed protocol of a new study intended to be a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of Pradaxa (dabigatran) or Coumadin (warfarin).

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From these points taken from the MINI-SENTINEL ASSESSMENT PROTOCOL: A PROTOCOL FOR ASSESSMENT OF DABIGATRAN (PDF document) that was posted online, we can see where the FDA's focus will be in this new 2014 Pradaxa safety study:

• Questions remain, however, about the outcomes associated with [Pradaxa (dabigatran)] outside of the clinical trial setting and in typical clinical practice populations. To address this, this protocol aims to assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of [Pradaxa (dabigatran)] and warfarin for patients with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database (MSDD).
• Toward that end, the primary comparison will be examining bleeding and thromboembolic outcomes between new use of [Pradaxa (dabigatran)] or warfarin in patients with nonvalvular atrial fibrillation in the MSDD.
• The primary outcomes will be the occurrence of ischemic stroke, intracranial hemorrhage, all strokes (ischemic stroke + intracranial hemorrhage) as well as episodes of major bleeding.

Some background information about this Pradaxa FDA study of can be found in this January 3, 2014 Forbes article by Larry Husten, "FDA Plans New Safety Assessment Of Dabigatran (Pradaxa)":

At this point there is no plan to assess the safety of the new oral anticoagulants that received approval after dabigatran, rivaroxaban (Xarelto, Johnson & Johnson) and Eliquis (Pfizer and BristolMyers Squibb).

A knowledgeable source said that the major purpose of the study will be to identify groups of patients who are at high risk for major bleeding events with [Pradaxa (dabigatran)]. Somewhat paradoxically, this might help bolster the drug, as it will then also identify groups more likely to benefit from treatment. On the other hand, the fact that similar studies are not being undertaken with the other new oral anticoagulants may well reinforce concerns about [Pradaxa (dabigatran)].

We will be watching the FDA and the medical news reports for future developments concerning this latest FDA safety review regarding Pradaxa and serious bleeding side effects, some of which can result in death.

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