Are you or a loved one currently taking Pradaxa? Have you taken Pradaxa in the past? Pradaxa is a prescription blood thinning agent (anticoagulant) that is prescribed to reduce the risk of stroke in patients with AFib (non-valvular atrial fibrillation), a heart rhythm abnormality. Pradaxa is manufactured by Boehringer Ingelheim and was approved by the U.S. Food and Drug Administration (FDA) on October 19, 2010.
Pradaxa Bleeding Problems – You are not alone
If you believe that you or a loved one may have suffered serious bleeding problems or other complications in connection with the use of the drug Pradaxa, we are here to help. Please call us toll free at 1-866-307-2147 or locally at (520) 622-3344 to schedule a free face-to-face Pradaxa lawsuit consultation. We will listen with compassion and put our passion for justice and decades of experience to work for you.
What you should know
Since December 2011, the Food & Drug Administration (FDA) has made available drug safety review information about Pradaxa and post-market reports of serious bleeding events. According to the FDA, bleeding that could potentially lead to serious or fatal outcomes is a complication of all anticoagulant therapies, and the Pradaxa drug label currently includes a warning about the possible risk of significant and sometimes fatal bleeding.
The FDA’s drug safety review was initiated to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than expected based on pre-market clinical trials. At this time, the FDA is stating that they continue to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label. They warn that patients should not stop taking Pradaxa without talking to their healthcare professionals, as discontinuing blood thinning medications can increase the risk of stroke, which can lead to permanent disability or death.
The FDA advises calling your healthcare professional immediately if you develop signs or symptoms of bleeding, including but not limited to:
- unusual bleeding from the gums
- nose bleeding that happens often
- menstrual or vaginal bleeding that is heavier than normal
- bleeding that is severe or that you cannot control
- pink or brown urine
- red or black stools (looks like tar)
- bruises that happen without a known cause or that get larger
- coughing up blood or blood clots
- vomiting blood or vomit that looks like coffee grounds
FDA Issues Pradaxa Valve Warning
The FDA is warning doctors not to prescribe Pradaxa® (dabigatran) to patients with mechanical heart valves. The drug maker Boehringer Ingelheim stopped the phase II RE-ALIGN trial, which tested three doses of the drug in patients with mechanical valve because patients with mechanical valves experienced more adverse events such as strokes, heart attacks and thrombus formation, compared with those taking warfarin (Coumadin). Pradaxa patients also saw more bleeding after valve surgery associated with Pradaxa compared with warfarin (Coumadin®).
What you can do
Contact your medical professional if you believe that you or a loved one is at risk for or currently experiencing a Pradaxa-related bleeding complication or side effect, contact your medical professional immediately for evaluation.
Report your side effects. Consumers and professionals can report suspected Pradaxa side effects or bleeding complications to the FDA’s MedWatch Adverse Event Reporting Program at fda.gov/MedWatch/report.htm, or by phone at 800-FDA-1088.
Obtain a Free Pradaxa Lawsuit Evaluation from Showard Law Firm. If you or a loved one has taken Pradaxa and experienced serious bleeding or other life threatening complications, please contact your health care professional first to communicate your concerns and decide together the best course of treatment. It’s important that you take care of your health first and foremost. After speaking with your doctor, if you feel you experienced or are experiencing serious bleeding or other life threatening complications due to Pradaxa, please call us toll free at 1-866-307-2147 or locally at (520) 622-3344.