Pradaxa is an anticoagulant medication that offers patients greater convenience, compared to older blood-thinners, such as warfarin. The drug received approval from the Food and Drug Administration (FDA) in 2010 and in the years since, has become one of the most prescribed drugs in its class. While Pradaxa proves effective in preventing blood clots and strokes in patients with atrial fibrillation, it's also been linked with uncontrollable bleeding and even death.
We've compiled answers to the most common questions our clients ask about Pradaxa and potentially dangerous side effects. Please review the list below, and learn more about what you can do if you sustained injuries while taking the drug. If you have questions about a potential Pradaxa bleeding lawsuit, contact McGartland Law to schedule an appointment for a free initial consultation to discuss your case.
Q: What is Pradaxa?
A: Manufactured by German pharmaceutical company Boehringer Ingelheim, Pradaxa (dabigatran etexilate mesylate) is an anticoagulant or blood-thinning medication used to prevent blood clots and strokes in patients with abnormal heart rhythm or atrial fibrillation. Although Pradaxa is a relatively new blood-thinning medication, it's one of the most prescribed drugs in its class.
Q: How does Pradaxa work?
A: Pradaxa works by inhibiting a clotting enzyme known as thrombin, which prevents platelets from sticking together to form clots. Studies indicate that preventing the formation of blood clots reduces the risk of stroke in patients with atrial fibrillation. In fact, blood clots are the leading cause of atrial fibrillation-related strokes.
Q: Why do people choose Pradaxa over warfarin?
A: Pradaxa offers patients more freedom compared to warfarin. For example, patients taking warfarin must submit to regular monitoring to ensure the drug is working effectively and must restrict their diet to exclude certain foods. Warfarin works by decreasing the amount of vitamin K in the blood, which inhibits the clotting process. Foods containing vitamin K must be avoided as they reverse warfarin's anticoagulant effects.
Q: Why is Pradaxa attractive to people?
A: Many patients consider Pradaxa to be more convenient than other common anticoagulant medications such as warfarin, because patients who are on Pradaxa don't require frequent blood tests, nor must they submit to strict dietary restrictions. Additionally, Pradaxa was shown to work better than warfarin in a clinical trial.
Q: Is there an antidote to Pradaxa?
A: The FDA approved Boehringer Ingelheim's Pradaxa antidote, Praxbind®, in October 2015. Before the approval of this antidote, there wasn't a safe and reliable way to reverse the effects of Pradaxa in patients experiencing uncontrollable bleeding. Dialysis under close monitoring was the only way to rid the blood of the medication, but not all patients could tolerate the dialysis, and the slow process was only able to remove 60 percent of the drug from the body.
Q: Why are people filing Pradaxa lawsuits?
A: Thousands of patients who experienced uncontrollable bleeding events while taking Pradaxa have filed lawsuits against the drug's manufacturer, Boehringer Ingelheim, alleging that the pharmaceutical company failed to adequately warn patients of the risk associated with taking the medication. These Pradaxa cases have been consolidated into multidistrict litigation in the United States District Court for the Southern District of Illinois, where they will be heard by Judge David R. Herndon.
Q: When was Pradaxa approved by the FDA?
A: The FDA approved Pradaxa in October 2010 for the prevention of blood clots and strokes in patients with atrial fibrillation. Pradaxa was originally approved without an antidote, which led to at least 1,000 bleeding deaths. In October 2015, the FDA fast-tracked approval of Boehringer Ingelheim's Pradaxa antidote, Praxbind.
Q: Has Pradaxa been recalled?
A: No, Pradaxa hasn't been recalled by the FDA or voluntarily recalled by its manufacturer, Boehringer Ingelheim. However, thousands of Pradaxa patients have filed lawsuits against the company, citing severe bleeding events and alleging it failed to warn patients of the risk associated with taking the drug.
Q: Are the risks for GI bleeding higher for Pradaxa than warfarin?
A: The FDA conducted a study comparing the risks of Pradaxa and warfarin in Medicaid and Medicare patients, and found patients taking Pradaxa had a much higher risk of experiencing gastrointestinal bleeding. However, Pradaxa was associated with an overall lower risk of clot-related stroke, brain bleeds, and death.
Q: What are the manufacturer warnings for Pradaxa?
A: According to Pradaxa's manufacturer, Boehringer Ingelheim, Pradaxa shouldn't be used by patients with mechanical prosthetic heart valves, active pathological bleeding, or a history of hypersensitivity to the drug's ingredients. Additionally, premature discontinuation of Pradaxa increases the risk of serious thrombotic events—such as blood clots—and spinal or epidural hematomas in patients undergoing spinal puncture or receiving neuraxial anesthesia. The most common adverse reactions associated with Pradaxa are bleeding and gastrointestinal issues.
Q: What are the most common adverse reactions and side effects associated with Pradaxa?
A: Patients have reported a number of side effects and adverse reactions while taking Pradaxa, including:
- Gastrointestinal problems such as nausea and vomiting
- Joint pain
- Weakness and fatigue
Excessive bleeding, both internal and external, is also common. Patients may experience frequent nosebleeds, or bleed profusely from the gums or cuts. Contact your physician if you notice any of these symptoms while taking Pradaxa.
Q: What are the severe side effects of Pradaxa?
A: Severe side effects associated with Pradaxa include:
- Coughing up blood
- Vomiting blood or a substance that looks like coffee grounds
- Bleeding of the kidneys
- Uncontrollable internal bleeding
- Brain hemorrhage
Patients having a severe allergic reaction to Pradaxa may experience chest pain or tightness; swelling of the face or tongue; wheezing or trouble breathing; and dizziness or fainting. Seek medical attention if you have any of these symptoms while taking Pradaxa.
Q: How does Pradaxa cause uncontrolled bleeding?
A: Pradaxa works by inhibiting thrombin, the body's main clotting enzyme. While this effectively prevents blood clots from traveling to the brain and causing strokes, it also prevents blood clots from forming to stop serious internal or external bleeding events.
Q: What are the symptoms of Pradaxa bleeding?
A: Symptoms of Pradaxa-related bleeding can include:
- Lethargy or weakness
- Headaches, dizziness or fainting
- Joint pain or swelling
- Unusual bruising
- Prolonged or uncontrollable bleeding from cuts, the nose, or gums
- Coughing up blood
- Brown or pink urine
- Black or bloody stools
- vomit that is bloody or looks similar to coffee grounds
Q: Is there a Pradaxa class action?
A: No, currently there isn't a class action case against Pradaxa. Instead, Pradaxa cases will be handled in multidistrict legislation state consolidated proceedings, and will be heard by Judge David R. Herndon in the United States District Court for the Southern District of Illinois.
Q: What should I do if I had a serious bleeding event while taking Pradaxa?
A: See your physician immediately to discuss another form of treatment. Don't stop taking Pradaxa on your own, as sudden discontinuation of the drug has been linked to an increased risk of stroke. Once you're medically able, contact an experienced and reputable personal injury or product liability attorney to determine if you're eligible to pursue compensation for your Pradaxa-related bleeding injury.
Q: Have Pradaxa lawsuits already been filed?
A: Thousands of patients have filed product liability lawsuits against Pradaxa's manufacturer, Boehringer Ingelheim, in U.S. state and federal courts. Many of these cases have been consolidated into multidistrict litigation and will be heard in the United States District Court for the Southern District of Illinois.
Q: How long do I have to file a Pradaxa bleeding injury lawsuit?
A: The statute of limitations laws in your state determine how long you have to file a lawsuit against Pradaxa's manufacturer. In most cases, the statute of limitations for personal injury cases is just two years—meaning that patients must file their lawsuits within two years of the date they were diagnosed with the Pradaxa-related bleeding injury. To learn more about the statute of limitations in your state and how it affects your ability to seek compensation for damages, contact McGartland Law today.
Q: How much does it cost to file a Pradaxa lawsuit?
A: Most of the time, there are no up-front costs associated with filing a Pradaxa lawsuit. Law firms that handle these types of cases tend to work on a contingency basis. This means they don't get paid until you do. Rather than paying for your legal representation upfront, you pay your attorney when the case concludes, using money from your settlement. This approach to payment ensures that victims can pursue the compensation—and justice—they deserve without regard to their current financial situation.
Q: How long will a Pradaxa lawsuit take?
A: It's difficult to determine or even estimate how long your case will take to litigate without first discussing the specific details of the case. Unfortunately, the length of a lawsuit can vary dramatically from case to case, with some resolving in weeks, while others take months or even years to complete. Contact McGartland Law today to schedule an appointment for a free initial consultation.
Q: What damages can I recover in a Pradaxa lawsuit?
A: If you or someone you love suffered a severe bleeding injury while taking Pradaxa, an experienced personal injury attorney can help you seek compensation for economic damages, such as medical bills (including medical-related travel expenses); lost wages caused by missing work due to poor health; and non-economic damages, such as pain and suffering. Contact McGartland Law today.