Pradaxa Gastrointestinal Bleeding Lawsuits
Posted on behalf of Goldberg Finnegan, LLC on Apr 22, 2012 in Drug Litigation
If you or someone that you care about has suffered a gastrointestinal bleed after taking Pradaxa call us at 1-888-213-8140. Pradaxa is often prescribed by cardiologists to treat Atrial Fibrillation. It was just approved by the FDA in October 2010. While Pradaxa has some benefits over Coumadin (also called Warfarin), there is evidence that it causes gastrointestinal bleeding at a higher rate-and GI bleeds can be fatal. If you are taking Pradaxa and have gastrointestinal problems-even stomach pains, you should call your doctor immediately to discuss your concerns. While all anticoagulants are known to cause bleeding, GI bleeds caused by Pradaxa cannot be treated with a Vitamin K Antidote as bleeds caused by Warfarin are treated. The safety and efficacy of Pradaxa was evaluated in a study called the RE-LY Study. This Pradaxa study involved 18,000 patients followed for a median of two years and given 150 mg 2x daily of Pradaxa. This dosage was shown to be associated with lower rates of stroke and systemic embolism and a lower incidence of intracranial hemorrhage. While these are significant advantages over Warfarin, unfortunately Pradaxa was associated with an increased rate of gastro intestinal bleeding.
Pradaxa also has a significantly higher rate of adverse events involving GI events (e.g. dyspepsia and gastritis). While these adverse events may not seem like a big deal in and of themselves, the problem is that individuals with these gastrointestinal events are then 3-4 times more likely to develop gastrointestinal bleeding which is a life threatening condition that is difficult to treat. Particular care should be given in prescribing Pradaxa to older patients, and patients with renal insufficiency. The Pradaxa label was recently changed in January 2012 to tell patients to contact their doctor if they have GI side effects, but the patient instructions as of 2012 do not. Rather the patient instructions tell patients only to contact their doctor if the side effects bother them or do not go away. We are concerned that the dangers of Pradaxa are understated. Again, if you or someone you love suffers and injury after taking Pradaxa we would like to speak to you. Call us at 1-888-213-8140.