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Pradaxa (dabigatran) is a blood-thinning drug used to reduce the risk of ischemic stroke and blood clots in people with atrial fibrillation. The responsible drug company is Boehringer Ingelheim Pharmaceuticals.
Since Pradaxa was approved by the FDA in October 2010, this popular anticoagulant medication has been associated with the following side effects:
- brain bleeds / hemorrhages
- intracranial hemorrhages
- hemorrhagic strokes
- Serious bleeding
- gastrointestinal (GI) bleeds
- rectal bleeding
- Irreversible life-threatening bleeding events
- Deaths as a result of excessive bleeding
Here are some of the possible Pradaxa-related bleeding events that have been reported to us:
Pradaxa – Serious Bleeding Event; Hemorrhage – 75 yr old woman
Pradaxa – Serious Bleeding Event; Death – 84 yr old woman
Pradaxa – Gastrointestinal (GI) Bleeding – 68 yr old man
Pradaxa – Intracranial Hemorrhage; Subdural Hematoma – 76 yr old man
Pradaxa – Serious Bleeding Event; Death – 86 yr old man
Pradaxa – Severe Stomach Bleeding – 76 yr old man
Pradaxa – Gastrointestinal (GI) Bleed – 74 yr old man
Pradaxa – Gastrointestinal (GI) Bleed; Massive Bleeding – Death – 24 yr old man
Pradaxa – Intracranial Hemorrhage – Death – 86 yr old man
Pradaxa – Serious Bleeding – 62 yr old woman
If you experienced serious side effects from the use of Pradaxa, or a person died due to an adverse reaction while taking Pradaxa, you may have a claim for legal compensation. Such claims involving a serious injury or death caused by the use of Pradaxa are made by filing a lawsuit in court. All states have statutes of limitations that determine the deadlines by which to file lawsuits involving Pradaxa side effects.
We encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
Thomas J. Moore, of the Institute for Safe Medication Practices, recently wrote a “Perspective” piece about new Pradaxa-versus-warfarin study, which is described below.
Medical researchers reviewed population-wide electronic medical records from the Clinical Data Analysis and Reporting System of the Hong Kong Hospital Authority to identify the 30-day readmission rates for patients with nonvalvular atrial fibrillation treated with Pradaxa (dabigatran) or warfarin.
The bottom line for this retrospective cohort study is that the patients treated with Pradaxa appeared to be at higher risk for 30-day hospital readmission due to bleeding.
In his “Perspective” piece, Moore added some contextual information pertinent to the Hong Kong researchers’ findings:
… This new study’s annualized hospitalization rates of 5% and 5.8% for [Pradaxa (dabigatran)] and warfarin for bleeding in patients with atrial fibrillation also are consistent with previously published results. However, had this Hong Kong study been conducted in the United States, one would expect even higher hospital admission rates for [Pradaxa (dabigatran)] because the lower 110-mg dose — taken by 75% in this population — was not available in the United States until recently, and is not recommended for use in atrial fibrillation.
The study also identifies an important new anticoagulant safety issue — high rates of rehospitalization for bleeding within 30 days affecting 13.5% of dabigatran patients compared with 5.1% of warfarin patients. After a bleeding event, the warfarin dose can be adjusted downward, a flexibility not available for [Pradaxa (dabigatran)] except for the untested 75-mg dose….
Given these still-present safety issues when using Pradaxa, we continue to investigate possible drug injury cases against the responsible drug company, Boehringer Ingelheim, for patients who have suffered serious bleeding events.
- Pradaxa And Xarelto May Double The Risk Of Heart Attacks Some Patients
- Earlier Pradaxa Settlements Do Not Stop Filing Of New Pradaxa Lawsuits
- The Pradaxa Gastrointestinal (GI) Bleeding Debate Continues: Is There An Increased Risk Or A Risk Reduction With Pradaxa Use?
- Pradaxa Adverse Drug Events (ADEs) Result In Death More Often Than Other Anticoagulants / Blood Thinners ADE Reports
- Pradaxa Safety Debate Continues During November 2012 With Many Different Conclusions And Positions
- Pradaxa Hemorrhage Cases May Occur In Oldest Patients Due To Age-Related Decline In Renal Function
- Pradaxa: FDA Investigating Possible Higher Than Expected Incident Rate Of Serious Bleeding Side Effects
All content by attorney Tom Lamb