Many patients or their survivors are filing a Pradaxa Lawsuit after the drug has caused serious and life-threatening injuries
Since being approved by the US Food and Drug Administration (FDA) on October 19th, 2010, Pradaxa, the first drug approved as an alternative to the anticoagulant warfarin, Pradaxa has been under serious review by the FDA due to post market reports of severe and possibly deadly bleeding in patients that have taken the anticoagulant. As a result, patients (or their families) that have taken Pradaxa and have suffered a bleeding event are filing claims against the drug manufacturer, Boehringer Ingelheim. For more information on whether or not you might have a claim, fill out the contact form on this page or call.
What is Pradaxa?
Pradaxa, which is manufactured by Boehringer Ingelheim, is in a class of anticoagulant medications called direct thrombin inhibitors. Pradaxa may reduce the risk of strokes and blood clots in patients with atrial fibrillation without heart valve disease. Atrial fibrillation is a condition in which the heart beats irregularly which can increase the risk of blood clots forming and possibly causing strokes.
From October 2010, when the FDA approved the anticoagulant Pradaxa, to August 2011, approximately 1.1 million prescriptions were dispensed to over 371,000 patients in the US. As an alternative to warfarin (Coumadin), Pradaxa does have some advantages in that it does not require monitoring and it doesn’t interact with other drugs or foods in the same way as warfarin. Both anticoagulants can cause excessive bleeding however warfarin does have an antidote while Pradaxa bleeding events are not reversible, there is no antidote.
Pradaxa Side Effects
There are many possible serious side effects for patients taking Pradaxa including abdominal pain, severe heartburn, nausea, and vomiting. One of the most serious and possibly deadly side effect is bleeding. Pradaxa can cause severe bleeding as it does affect the body’s blood clotting proteins. Unlike the anticoagulant, warfarin, there is no antidote when this happens.
Some signs or symptoms of bleeding from Pradaxa:
- Severe or uncontrollable bleeding
- Unusual bruising
- Coughing up or vomiting blood
- Pink or brown urine
- Red or black tarry stools
- Unexplained joint pain or swelling
On December 7, 2011, the FDA announced that they are investigating the drug Pradaxa due to an unusually large number of reports, over 500, that patients taking Pradaxa have suffered from serious bleeding events. The medical authorities in Japan and Australia had already issued a safety warning. In Europe, the European Medicines Agency advised doctors to check their patient’s kidney function before prescribing Pradaxa after citing 256 cases of fatal bleeding after taking the drug. Pradaxa could build up in a patient’s bloodstream if not cleared by the kidneys.
On January 10, 2012, the FDA announced a new danger for patients taking Pradaxa. Researchers from the Cleveland Clinic found that those taking Pradaxa have a 33% higher risk of heart attacks or heart disease than patients taking warfarin. This new finding is based on seven clinical trials that enrolled 30,514 patients.
The risk of bleeding when taking Pradaxa may be higher for those in the following categories:
- 75 years of age or older
- Have kidney problems
- Diagnosed with stomach ulcers
- Take medicines that increase risk of bleeding like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
Shortly after Pradaxa was released, the FDA received a large number of reports of bleeding injuries as a result of taking Pradaxa. The FDA has since announced that they are reviewing the safety of Pradaxa in order to determine whether or not a Pradaxa recall is necessary. It is possible that the initial clinical trials were faulty which allowed the defective drug manufacturer, Boehringer Ingelheim to rush the drug to the market.
Many of the patients that have suffered dangerous bleeding events or their families are now filing claim against Boehringer Ingelheim. Contact us or call now if you might have the right to receive compensation for your medical expenses and suffering. Our Pradaxa lawsuit attorneys are ready to fight for your rights!