Pradaxa: GI Bleeds, Strokes, or Severe Uncontrolled Bleeding
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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
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.
Recent Side Effects Case Evaluations
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
Most Recent Article About This Drug
We are watching to see whether the FDA and/or European drug regulators require a Pradaxa liver injury label change adding a new warning about an increased risk of acute liver failure and drug-induced hepatitis — like what was done in Japan last year and is being done now in Canada.
In May 2018 Health Canada announced that their Pradaxa drug safety review evaluating the risk of liver injury associated with Pradaxa concluded that there may be a link. Accordingly, Health Canada is working with the responsible pharmaceutical company to update the Canadian product monograph, or drug label, for Pradaxa (dabigatran) to inform healthcare professionals and patients about this increased risk of liver injury.
To read more of this article, click below:
In more detail, from this Health Canada document, “Summary Safety Review – PRADAXA (dabigatran etexilate) – Assessing the potential risk of liver injury”:
Safety Review Findings
- At the time of the review, Health Canada had received 27 Canadian reports of severe liver injury related to the use of Pradaxa. Of these reports, 4 were further assessed as they were suspected to be linked to the use of Pradaxa. 3 of the 4 reports, including 1 death, showed a possible link between liver injury and the use of Pradaxa. [footnote omitted]
- This review also looked at 105 international reports of severe liver injury related to the use of Pradaxa. Of these reports, 16 were further assessed as they were suspected to be linked to the use of Pradaxa. 13 of these 16 reports, including 2 deaths, showed a possible link between liver injury and the use of Pradaxa.
That relatively recent Health Canada Pradaxa Safety Review document goes on to point out: “The Pharmaceuticals and Medical Devices Agency of Japan issued a risk communication and updated the product label on September 12, 2017 to include liver injury (i.e. ‘acute hepatic failure, hepatic function disorder, and jaundice’).” [footnote omitted].[Read article in full at original source]
Earlier articles by attorney Tom Lamb on the Side Effects Blog:
- Pradaxa vs. Warfarin: Rehospitalizations For 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