PRADAXA reversal treatment banner

PRADAXA Clinical Trial Data and Real-world Assessments

The safety of PRADAXA has been studied extensively

In 2010, PRADAXA was the first FDA-approved alternative to warfarin to reduce the risk of stroke in atrial fibrillation (AFib) not caused by a heart valve problem. The approval was based on a clinical trial that included over 18,000 patients. Since then, over 12 million prescriptions have been filled in the U.S. Today, on the basis of 4 clinical trials involving over 9,000 patients,

PRADAXA is approved to treat blood clots in the veins of your legs (deep vein thrombosis, or DVT) or lungs (pulmonary embolism, or PE) in patients who have been treated with blood thinner injections, and to reduce the risk of them occurring again. In these trials, PRADAXA was compared to warfarin or to placebo (sugar pills) for the treatment of DVT and PE patients.

In 2010, PRADAXA was the first FDA-approved alternative to warfarin to reduce the risk of stroke in atrial fibrillation (AFib) not caused by a heart valve problem. The approval was based on a clinical trial that included over 18,000 patients. Since then, over 12 million prescriptions have been filled in the U.S. Today, on the basis of 4 clinical trials involving over 9,000 patients, PRADAXA is approved to treat blood clots in the veins of your legs (deep vein thrombosis, or DVT) or lungs (pulmonary embolism, or PE) in patients who have been treated with blood thinner injections, and to reduce the risk of them occurring again. In these trials, PRADAXA was compared to warfarin or to placebo (sugar pills) for the treatment of DVT and PE patients.

Below, you will find a list and brief description of each of these trials, studies, and reviews

For patients with atrial fibrillation not caused by a heart valve problem

Department of Defense
(DoD) Study
- 2015 25,000+ patients
74 years of age (average)
  • Evaluated the safety and how well PRADAXA works compared to warfarin
FDA Medicare Study - 2014 134,000+ patients
65 years of age or older
  • Evaluated the safety and how well PRADAXA works compared to warfarin
  • Largest observational study in this treatment class
Brigham & Women’s Study - 2015 38,000+ patients
68 years of age (average)
  • Evaluated the safety and how well PRADAXA works compared to warfarin
  • Patients included in the study ranged from 18 to over 75 years of age
FDA Mini-Sentinel
Assessment
- 2012 50,000+ patients
  • Investigated safety for new users
    of PRADAXA and warfarin
  • 1st FDA post-marketing assessment in PRADAXA’s treatment class
RE-LY® Trial - 2009 18,000+ patients
72 years of age (average)
  • Tested how well PRADAXA works compared to warfarin at reducing the risk of stroke in patients with atrial fibrillation not caused by a heart valve problem
RELY-ABLE® Extension - 2013 5,000+ patients
73 years of age (average)
  • Tested the safety profile of PRADAXA in a long-term safety evaluation, conducted after the RE‑LY® trial

For patients with deep vein thrombosis (DVT) and pulmonary embolism (PE)

RE-COVER® Trial - 2009 2,000+ patients
55 years of age (average)
  • Compared the safety of PRADAXA to warfarin in treating patients with DVT and PE
RE-COVER II™ Trial - 2013 2,000+ patients
55 years of age (average)
  • An extension of the original RE‑COVER® Trial
RE-SONATE® Trial - 2013 1,000+ patients
56 years of age (average)
  • Tested how well PRADAXA works compared to placebo in reducing the risk of recurrence of DVT and PE
RE-MEDY™ Trial - 2013 2,000+ patients
55 years of age (average)
  • Tested how well PRADAXA works compared to warfarin in reducing the risk of recurrence of DVT and PE

Do you know how PRADAXA
compares to warfarin?

Discover the differences

IMPORTANT SAFETY INFORMATION AND USE OF PRADAXA

For people taking PRADAXA for atrial fibrillation: Do not stop taking PRADAXA without talking to the doctor who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke. PRADAXA may need to be stopped prior to surgery or a medical or dental procedure. Your doctor will tell you when you should stop taking PRADAXA and when you may start taking it again. If you have to stop taking PRADAXA, your doctor may prescribe another medicine to help prevent a blood clot from forming.

PRADAXA can cause bleeding which can be serious and sometimes lead to death. Don’t take PRADAXA if you:

  • currently have abnormal bleeding;
  • have ever had an allergic reaction to it;
  • have had or plan to have a valve in your heart replaced

Your risk of bleeding with PRADAXA may be higher if you:

  • are 75 years old or older
  • have kidney problems
  • have stomach or intestine bleeding that is recent or keeps coming back or you have a stomach ulcer
  • take other medicines that increase your risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
  • have kidney problems and take dronedarone (Multaq®) or ketoconazole tablets (Nizoral®)

Call your doctor or seek immediate medical care if you have any of the following signs or symptoms of bleeding:

  • any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time
  • unusual or unexpected bruising
  • coughing up or vomiting blood; or vomit that looks like coffee grounds
  • pink or brown urine; red or black stools (looks like tar)
  • unexpected pain, swelling, or joint pain
  • headaches and feeling dizzy or weak

Spinal or epidural blood clots (hematoma). People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

  • a thin tube called an epidural catheter is placed in your back to give you certain medicine
  • you take NSAIDs or a medicine to prevent blood from clotting
  • you have a history of difficult or repeated epidural or spinal punctures
  • you have a history of problems with your spine or have had surgery on your spine.

If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).

Take PRADAXA exactly as prescribed. It is important to tell your doctors about all medicines (prescription and over‑the‑counter), vitamins, and supplements you take. Some medicines may affect the way PRADAXA works.

PRADAXA can cause indigestion, stomach upset or burning, and stomach pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.

What is PRADAXA?

PRADAXA is a prescription blood thinner medicine that lowers the chance of blood clots forming in your body.
PRADAXA is used to:

  • reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of a stroke.
  • treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and reduce the risk of them occurring again.

PRADAXA is not for use in people with artificial (prosthetic) heart valves.

Please see full Prescribing Information and Medication Guide.

The health information contained in this Website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademarks Pradaxa®, PRADAXA with associated design ®, SolutionsPlus® and related images under license. Other referenced trademarks are owned by third parties.

This site is intended for U.S. residents only. Products discussed herein may have different names and labeling in different countries.

Use of this site is subject to the Internet Site Legal Notices and Disclaimers and Privacy Notice

Copyright © 2016 Boehringer Ingelheim Pharmaceuticals, Inc. All Rights Reserved. [10/16]

PC-PX-0236-CONS

SEE MORE

Important safety information and use of PRADAXA

For people taking PRADAXA for atrial fibrillation: Do not stop taking PRADAXA without talking to the doctor who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke. PRADAXA may need to be stopped prior to surgery or a medical or dental procedure. Your doctor will tell you when you should stop taking PRADAXA and when you may start taking it again. If you have to stop taking PRADAXA, your doctor may prescribe another medicine to help prevent a blood clot from forming.

PRADAXA can cause bleeding which can be serious and sometimes lead to death. Don’t take PRADAXA if you:

  • currently have abnormal bleeding;
  • have ever had an allergic reaction to it;
  • have had or plan to have a valve in your heart replaced

Your risk of bleeding with PRADAXA may be higher if you:

  • are 75 years old or older
  • have kidney problems
  • have stomach or intestine bleeding that is recent or keeps coming back or you have a stomach ulcer
  • take other medicines that increase your risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
  • have kidney problems and take dronedarone (Multaq®) or ketoconazole tablets (Nizoral®)

Call your doctor or seek immediate medical care if you have any of the following signs or symptoms of bleeding:

  • any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time
  • unusual or unexpected bruising
  • coughing up or vomiting blood; or vomit that looks like coffee grounds
  • pink or brown urine; red or black stools (looks like tar)
  • unexpected pain, swelling, or joint pain
  • headaches and feeling dizzy or weak

Spinal or epidural blood clots (hematoma). People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

  • a thin tube called an epidural catheter is placed in your back to give you certain medicine
  • you take NSAIDs or a medicine to prevent blood from clotting
  • you have a history of difficult or repeated epidural or spinal punctures
  • you have a history of problems with your spine or have had surgery on your spine.

If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).

Take PRADAXA exactly as prescribed. It is important to tell your doctors about all medicines, vitamins, and supplements you take. Some medicines may affect the way PRADAXA works.

PRADAXA can cause indigestion, stomach upset or burning, and stomach pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088

What is PRADAXA?

PRADAXA is a prescription blood thinner medicine that lowers the chance of blood clots forming in your body. PRADAXA is used to:

  • reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of a stroke.
  • treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and reduce the risk of them occurring again.

PRADAXA is not for use in people with artificial (prosthetic) heart valves.

Please see full Prescribing Information and Medication Guide.

The health information contained in this Website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademarks Pradaxa®, PRADAXA with associated design ®, SolutionsPlus® and related images under license. Other referenced trademarks are owned by third parties.

This site is intended for U.S. residents only. Products discussed herein may have different names and labeling in different countries.

Use of this site is subject to the Internet Site Legal Notices and Disclaimers and Privacy Notice

Copyright © 2015 Boehringer Ingelheim Pharmaceuticals, Inc. All Rights Reserved. [12/15]

PC-PXD-0219-CONS