Pradaxa Injury Lawyers
If you or someone you love suffered a gastrointestinal bleeding event or other injury after taking Pradaxa we would like to discuss your legal rights with you. Call us at (888) 213-8140.
It is our opinion that the current warning and labeling of Pradaxa is inadequate. Patients taking Pradaxa who suffer any gastrointestinal event, even stomach pain, should call their doctor immediately. Scientific evidence suggests that once gastrointestinal side effects occur, Pradaxa patients are 3 to 4 times more likely to have a GI bleed which can be, and often is a fatal bleeding event.
If you or someone you love has suffered any serious side effects while consuming this prescription drug, our lawyers can review your claim free of charge.
What is Pradaxa?
Pradaxa (Dabigatran etexilate) is an anticoagulant approved by the FDA in October 2010.
It is used to treat Atrial Fibrillation, which is a heart condition that increases the risk of stroke and death. Doctors and Cardiologists have been prescribing Pradaxa instead of Warfarin (also known as Coumadin) since its approval because it is easier to use than Coumadin in that patients do not need to undergo frequent blood testing as they have to do with Coumadin, and also because there may be a lower risk of intracranial hemorrhage and other bleeding events as compared with Coumadin/Warfarin.
However, Pradaxa causes a much higher rate of gastrointestinal related events such as dyspepsia and gastritis as compared with Warfarin. Individuals who develop these gastrointestinal events are then three to four times more likely to develop gastrointestinal bleeding.
When this major gastrointestinal bleeding adverse event occurs, unfortunately there is no antidote and it is difficult or impossible for doctors to stop the bleeding before major damage or death occurs.
By contrast, with Coumadin (aka Warfarin) there is an antidote that is effective in controlling the bleeding. Older patients, patients with renal insufficiency, and patients with a history of gastrointestinal bleeding are especially at risk for uncontrolled bleeding events on Pradaxa.
What Are The Side Effects of Pradaxa?
In late 2011, the FDA began investigating if severe bleeding events were more frequent with users of Pradaxa and is working closely with the manufacturer (Boehringer Ingelheim) to help review the post-market reports of this issue.
Some of the most common side effects of Pradaxa are:
- Bruises occurring without a known cause
- Coughing up blood
- Frequent nose bleeds
- Heavier than normal menstrual bleeding
- Irregular bleeding in the gums or mouth
- Pink or brown urine
- Red or black stools
- Vomiting blood or vomit that looks like coffee grounds
If you or a loved one has experienced any of these symptoms after consuming Pradaxa, seek medical attention immediately.
If Pradaxa Is Dangerous, Why Was It Prescribed?
The popularity of Pradaxa with Cardiologists and other doctors seems to be based on the suggestion by Pradaxa's manufacturer that it is safer than Warfarin. It should be noted, however, that there is only one study known as the RE-LY Study-that indicates that Pradaxa is safer than Warfarin and a large number of the medical professionals conducting the study disclosed conflicts of interest.
It also does not appear that the study was double blinded or placebo controlled.
As more and more major gastrointestinal bleeding events are occurring, the manufacturer of Pradaxa changed its warning label in January 2012. The new warning now warns that:
- There is no reversal agent for certain bleeding events
- Pradaxa should not be prescribed to those with severe renal impairment
.... and that dose should be reduced for those with lower levels of renal impairment. The typical dose of Pradaxa is 150 mg twice daily.
Need Help? Contact Our Pradaxa Injury Lawyers Today
At the law offices of Goldberg Finnegan, our entire legal team are dedicated to the pursuit of justice.
We strongly feel that negligent pharmaceutical companies need to be held accountable for their actions and we have the experience and resources to do just that.
Not sure if you have a claim? Our highly trained lawyers have helped to recover MILLIONS in compensation for our clients and offer 100% FREE case reviews to help determine if you have grounds to file a damages lawsuit.
We also ONLY GET PAID WHEN WE WIN.