Pradaxa®
is a direct thrombin inhibitor that is indicated to reduce the risk of stroke
and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa®
was approved by the Food and Drug Administration in 2010. The FDA approved two
dosages: 75 mg and 150 mg, to be taken twice daily. Pradaxa® was the first
anticoagulation medication approved in the U.S. in more than 50 years for
patients with non-valvular atrial fibrillation.
Prior to the FDA’s approval of
Pradaxa®, warfarin was the only oral
anticoagulation
available in the U.S. for reducing stroke and systemic embolism in patients
with atrial fibrillation. Unlike patients who use Pradaxa®, users of warfarin
must follow dietary restrictions and regularly monitor their blood levels (INR)
by undergoing blood tests and potentially adjusting the dose of their
medication. Warfarin is actually a form of rat poison.
The advantages of warfarin over Pradaxa®
is that warfarin is heavily monitored and requires constant blood tests to make
sure that it is working properly, and most importantly, has an antidote (Vitamin
K) to help stop uncontrollable bleeding.
We believe that the manufacturers of
Pradaxa® overstated the efficacy of Pradaxa® with respect to preventing stroke
and systemic embolism and failed to adequately disclose to patients that there
is no drug, agent or means to reverse the anticoagulation effects of Pradaxa®
and that such irreversibility could have permanently disabling,
life-threatening and fatal consequences.
From October 2010 until the end of
March 2011, approximately 272,119 prescriptions for Pradaxa® were written in
the US. During that same period, there were 932 Pradaxa®-associated “Serious
Adverse Event” (“SAE”) Medwatch reports filed with the FDA, including at least
120 deaths and over 500 reports of severe, life-threatening bleeding. From
April 1, 2011, until the end of June 2011, there were an additional 856
Pradaxa®-associated “SAE” Medwatch reports filed with the FDA, including at
least 117 deaths and over 510 reports of severe, life-threatening bleeding.
During March, 2011, the
manufacturers of Pradaxa® modified the US labeling and prescribing information
for Pradaxa®, which included additional information regarding the use of
Pradaxa® in patients taking certain medications. Also, almost 1800 SAE Medwatch
reports were filed with the FDA, including at least 237 deaths and over 1,000
reports of severe, life-threatening bleeding.
All over the country, hundreds of
lawsuits have been filed against the manufacturers of Pradaxa®. Most of these
cases have been consolidated into an MDL.
Common side effects from Pradaxa® include:
- Brain Hemorrhaging/Bleeding
- Gastrointestinal (GI) Bleeding
- Kidney Bleeding
- Internal Bleeding
- Heart Attack/ Cardiac Injury
- Death
Our firm is currently investigating
claims for those people who have been injured by taking Pradaxa®. If you would
like a free case evaluation, please contact Booth Samuels at toll free
1-866-515-8880 or at booths@pittmandutton.com.
