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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; 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
Pradaxa – Serious Bleeding within the Pericardium (sack that surrounds heart) and Abdomen – 89 yr old woman
Pradaxa – Serious Bleeding within the Pericardium (sack that surrounds heart) – 75 yr old man
Pradaxa – Serious Bleeding Event – 85 yr old woman – almost fatal occurence; in hospital for 2 weeks, followed by 7 weeks in nursing facility
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.
In March 2017 the British Journal of Clinical Pharmacology published this article, “Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants”, which reports on the first retrospective cohort study to compare the risk of acute myocardial infarction (AMI), or heart attack, with use of direct-acting oral anticoagulants (DOACs) with that associated with vitamin K antagonists (VKAs), e.g., warfarin.
The bottom line is that the medical researchers conducting this study found a two-fold increase in the risk of heart attacks with use of Pradaxa (dabigatran) and Xarelto (rivaroxaban) in comparison with warfarin in patients using those drugs for atrial fibrillation (AF) therapy.
Specifically, from the Results section of the Abstract for this March 2017 medical journal article: “The risk of AMI was doubled when we compared current use of DOACs with current use of VKAs [adjusted HR 2.11; 95% confidence interval (CI) 1.08, 4.12]….”
And from the Discussion part of the full article:
In conclusion, our cohort study identified a twofold increase in the risk of AMI when using DOACs, [Xarelto (rivaroxaban)] or [Pradaxa (dabigatran)], in comparison with VKAs, in AF therapy in real-world patients. In addition, our results showed that in AF patients, the risk of AMI with current use of aspirin as monotherapy is higher than with current use of VKAs. VKAs probably have greater beneficial effects on AMI than DOACs. Ongoing research is needed as the use of DOACs increases in the population.
While this observational study reports that there is a correlation between the use of Xarelto (rivaroxaban) or Pradaxa (dabigatran) with an increased risk for myocardial infarction (MI), or heart attack, it is important to keep in mind that correlation does not prove causation.
Rather, in order to definitively answer the question “Do direct oral anticoagulants (DOACs) increase the risk for myocardial infarction (MI), or heart attack”, we will need a well-designed study. One hopes that Boehringer Ingelheim Pharmaceuticals (Pradaxa) or Janssen Pharmaceuticals (Xarelto), as the responsible drug companies, have such a drug-safety study currently underway or planned to begin soon.
- 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