Pradaxa Internal Bleeding Lawsuit
Pradaxa (generic: dabigatran) has been associated with serious, and potentially fatal internal bleeding. While no Pradaxa recall has been issued, health regulators in the U.S. and elsewhere are investigating reports of Pradaxa internal bleeding and Pradaxa-related deaths. If you or someone you love suffered from serious Pradaxa hemorrhaging, you may be eligible to file a Pradaxa lawsuit to obtain compensation for your injuries.
The Pradaxa lawyers at Parker Waichman, LLP are investigating Pradaxa harmful side effects, including:
- Pradaxa internal bleeding
- Pradaxa gastrointestinal (GI) bleed
- Pradaxa brain hemorrhaging
- Pradaxa kidney bleeding
- Deaths caused by Pradaxa
Our Pradaxa attorneys are offering free Pradaxa lawsuit consultations to anyone who suffered from serious internal hemorrhaging or other harmful Pradaxa side effects. If you or a loved one were injured by Pradaxa, we urge you to contact our Pradaxa lawyers today to protect your legal rights.
Pradaxa Internal Bleeding
Pradaxa is an oral blood thinner that is used as an alternative to warfarin to prevent strokes associated with abnormal heart rhythm (atrial fibrillation). Approved by the U.S. Food & Drug Administration (FDA) in October 2010, Pradaxa is part of a class of drugs known as “direct thrombin inhibitors” that work by inhibiting an enzyme in the blood involved in clotting. Internal Bleeding is the most serious side effect of taking Pradaxa. Pradaxa is excreted through the kidneys, thus impaired kidney function could lead to abnormally high levels of the drug in circulation, leading to excessive Pradaxa internal bleeding. Unlike warfarin, there is no antidote for Pradaxa internal hemorrhaging.
Pradaxa Internal Bleeding in the Re-LY Clinical Trial
The RE-LY clinical trial found that up to 16.4% of Pradaxa users may experience internal hemorrhaging. The same study also found that:
- 17.4% of people taking Pradaxa who needed emergency surgery experienced major Pradaxa bleeding
- 3.3% of users experience serious Pradaxa bleeding
- 1.5% experience life-threatening Pradaxa hemorrhaging
- 0.3% experience Pradaxa brain hemorrhaging
According to the Pradaxa label, the study also found that Pradaxa 150 mg resulted in a higher rate of major Pradaxa GI bleeds and any other GI bleeds compared to warfarin. In patients older 75 years of age, the risk of major Pradaxa internal bleeding may be greater with Pradaxa than with warfarin.
Pradaxa Bleeding Deaths
The have been 260 reports of fatal Pradaxa bleeding among patients worldwide. The Pradaxa bleeding deaths included 21 in Europe and at least 14 in Japan. It is not known if or how many Pradaxa-related deaths may have occurred in the U.S. The Pradaxa bleeding deaths occurred between March 2008 and October 31, 2011, according to Boehringer Ingelheim, the maker of Pradaxa.
Symptoms of Pradaxa Internal Hemorrhaging
Symptoms of Pradaxa excessive bleeding may include:
- Unusual bruising or bleeding
- Pink or brown urine
- Red or black tarry stools
- Coughing up blood
- Vomiting that resembles blood or looks like coffee grounds
- Bleeding from the gums
- Frequent nosebleeds
- Weakness and swelling of the arms, hands, feet, ankles or lower legs
- Joint pain or swelling
Pradaxa Bleeding Investigations
Reports of excessive Pradaxa bleeding and Pradaxa-related deaths are being investigated by health regulators in several countries:
- On December 8, 2011, the FDA said it was investigating post-marketing reports of serious Pradaxa hemorrhaging, but did not indicate how many such reports it had received. At the same time, the FDA said it continues to believe Pradaxa “provides an important health benefit when used as directed,” and told patients with atrial fibrillation not to stop taking the drug without talking to their doctor.
- In October 2011, the European Medicines Agency (EMA) cautioned European doctors to subject Pradaxa patients older than 75, as well as those with renal impairment, to annual kidney checks to mitigate Pradaxa bleeding risks.
- In August, Japanese regulators told Boehringer Ingelheim to issue a warning for the drug after 81 of the almost 64,000 mainly elderly patients taking the drug there suffered excessive Pradaxa hemorrhaging. At least 14 people in Japan have suffered Pradaxa-related deaths.
- In New Zealand, two patients died while taking Pradaxa. Thirty-six additional patients suffered excessive Pradaxa bleeding.
Legal Help for Victims of Excessive Pradaxa Bleeding
Parker Waichman, LLP is one of the preeminent personal injury law firms in the U.S. Parker Waichman, LLP is listed in Best Lawyers, the oldest and most respected peer-review publication in the legal profession. The attorneys of Parker Waichman, LLP are also the authors of "Personal Injury Law for Dummies,” an easy-to-understand guide to all aspects of personal injury law.
If you or a loved one suffered excessive internal bleeding while taking Pradaxa, or may have been the victim of a Pradaxa-related death, you have valuable legal rights. To discuss your potential Pradaxa lawsuit with one of our Pradaxa lawyers, please fill out our online form or call 1-800 LAW INFO (1-800-529-4636) today.