The Gallagher Law Firm is currently litigating Pradaxa lawsuit cases. Our staff is exceptionally knowledgeable about Pradaxa, its risks, and the options you have if you have been harmed after taking it.
No matter where you are, you are invited to contact us online or call (888) 222-7052 for a free phone discussion or free in-office consultation.
Pradaxa Information Summary
Pradaxa (Generic name: dabigatran etexilate) is an oral anticoagulant in the direct thrombin inhibitor class of drugs developed by the pharmaceutical company Boehringer Ingelheim. Pradaxa is commonly used as an alternative to warfarin (Coumadin® or Jantoven®) because it does not require frequent blood testing and dosing adjustments like warfarin.
FDA Approved Pradaxa October 2012
Pradaxa was the first alternative to warfarin — the most commonly used drug to treat non-valvular atrial fibrillation — approved by the FDA in nearly 60 years so doctors were eager to learn about, and use, this promising new drug from Boehringer Ingelheim.
Primary Benefits of Pradaxa
Pradaxa was created as an alternative to warfarin, which is commonly known as Coumadin® or Jantoven®. According to Pradaxa marketing materials, the *primary benefits of Pradaxa (as compared to warfarin) include:
- Clinical trial showed 35% reduction of risk of stroke when compared to warfarin
- No need for regular blood tests to check if blood-thinning level is in the right range
- Requires no changes to diet
*These three factors are commonly repeated together throughout Pradaxa’s marketing materials.
Pradaxa Side Effects
The possible side effects of Pradaxa include, but may not be limited to the following:
- Gatronintestinal Bleeding
- Hematuria (blood in the urine)
- Bleeding Gums
- Excessive Menstrual Bleeding
- Excessive Bruising
- Cerebral Bleeding (hemorrhagic stroke)
- Pulmonary Hemorrhage (bleeding from the lungs)
- Death by Bleeding to Death
If you take Pradaxa and are experiencing any of these side effects, notify your doctor immediately. The most common causes of discontinuation of Pradaxa treatment were bleeding and gastrointestinal events (GI events range from mild to severe).
Pradaxa Bleeding and Deaths
According to the Pradaxa information website: ”PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.”
There is no question about whether Pradaxa causes bleeding. The company readily admits this fact and knew about the issue when the drug was approved by the FDA. A major concern now is whether the rate of Pradaxa-related bleeding was underestimated or undervalued by the makers of Pradaxa.
In November 2011, Boehringer Ingelheim said Pradaxa was linked to 260 deaths worldwide.
According to Reuters, European regulators recommended patients about to take Pradaxa should have their kidneys checked and Japanese regulators told Boehringer Ingelheim to issue a strong warning to doctors of potentially fatal bleeding resulting from the use of Pradaxa.
Major Concerns About Pradaxa
No Antidote or Reversal Agent
Unlike warfarin, whose effectiveness and impact can be rapidly reversed by the introduction of vitamin K, Pradaxa has no such antidote or reversal agent. While some procedures, such as the administration of activated charcoal or hemodialysis, may lessen the impact of the Pradaxa, there is no reversal agent. This effectively means there is little that can be done to treat severe bleeding caused by Pradaxa.
No “Black Box Warning”
The FDA has not issued a black box warning requirement for Pradaxa which is surprising to many considering the proven dangers and admission by the producers (Boehringer Ingelheim) that patients have died because of the drug.
No Dosing Adjustments Touted Above Risks
Patients taking warfarin must regularly provide blood samples for testing and doctors must adjust prescription levels (and dietary instructions) according to the results of the tests. The management of warfarin is tedious. On the other hand, Pradaxa is prescribed to patients at a specific dosage which they continue to take with no dosage adjustments (or blood tests) required. This, in itself, is not bad.
The concern is that this benefit was touted by marketing materials and sales people so highly above the risks of Pradaxa that doctors were more eager to move patients to Pradaxa than they might have been if the information provided was more objective and informative in nature.
Pradaxa lawsuits have been filed against the makers, Boehringer Ingelheim, on behalf of injured plaintiffs and by the family members of patients who died from excessive bleeding caused by Pradaxa.
If you are interested in learning more about legal action and your options, you are invited to contact The Gallagher Law Firm online or call (888) 222-7052 for a free phone discussion or free in-office consultation.