WHY PRADAXA?
IN THIS SECTION, WE WILL EXPLORE:
- What is PRADAXA and how it works
- How PRADAXA compares to warfarin
- Safety and side effects of PRADAXA
- Talking to your doctor about PRADAXA
- Information about the clinical studies conducted for PRADAXA
What is PRADAXA?
PRADAXA was introduced in 2010 as the first FDA-approved alternative to warfarin to reduce 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 adult patients. Since then, over 17 million prescriptions for PRADAXA have been filled in the U.S.
PRADAXA is also approved to treat blood clots in the veins of your legs (deep vein thrombosis, or DVT) or lungs (pulmonary embolism, or PE) in adult patients who have been treated with blood thinner injections, and to reduce the risk of them occurring again. Its approval was based on 4 clinical trials comparing it to warfarin or to placebo (sugar pills) for the treatment of DVT and PE in over 9,000 adult patients.
How PRADAXA Works
PRADAXA is a type of anticoagulant (blood thinner) known as a direct thrombin inhibitor. It is used to lower the chance of blood clots forming in your body by blocking thrombin—the blood's central clotting agent.
See how PRADAXA works for:
PRADAXA reduces the risk of clots in the heart that cause a stroke
Blood clots are the leading cause of AFib-related strokes
For adults with AFib not caused by a heart valve problem, PRADAXA reduces the risk of a blood clot forming in the heart and traveling to the brain, where it can cause a stroke. A stroke caused by a blood clot that reduces blood flow, is called an ischemic (is-KEE-mic) stroke.
To learn more about how these clots can form, click here.
How PRADAXA helps stop clots from forming in your heart
PRADAXA works by attaching itself to thrombin—the blood's central clotting agent. This reduces the ability of the thrombin to form a clot. That is why it is so important that you keep taking PRADAXA exactly as prescribed by your healthcare provider. Stopping PRADAXA increases your risk of having a stroke or forming blood clots.
In a clinical trial, PRADAXA was proven superior to warfarin at reducing risk of stroke in adult patients with AFib not caused by a heart valve problem.
PRADAXA treats DVT/PE blood clots and reduces the risk of recurrence
DVT and PE are serious medical conditions
For people who have been treated with an injectable blood thinner for 5 to 10 days, PRADAXA treats blood clots in the veins of your legs (DVT) or lungs (PE), and reduces the risk of recurrence.
To learn more about how these clots can form, click here.
Some of the risk factors for developing a blood clot include:
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staying still for a long period of time
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injury to your veins
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surgery and certain medicines given during surgery
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taking birth control pills or hormone replacement therapy
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pregnancy
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personal or family history of DVT or PE
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blood clotting disorders
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being overweight
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being over 60 years of age, although DVT or PE can develop at any age
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cancer
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smoking
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heart failure
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inflammatory bowel disease
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pacemaker or catheter
How PRADAXA helps reduce the risk of clot formation in the legs and lungs
PRADAXA works by attaching itself to thrombin—the blood's central clotting agent—to reduce the ability of the thrombin to form a clot. That is why it is so important that you keep taking PRADAXA exactly as prescribed by your doctor. Stopping PRADAXA increases your risk of developing DVT and PE.
In clinical trials, PRADAXA was proven as effective as warfarin for treatment of DVT and PE in patients who had already been on an injectable blood thinner for 5 to 10 days. PRADAXA was also proven as effective as warfarin in reducing the risk of recurrence of DVT and PE in patients who have been previously treated.
How PRADAXA Compares
If you have atrial fibrillation not caused by a heart valve problem and are currently taking warfarin, you may have options. In a clinical trial, PRADAXA was proven to work better than warfarin at reducing the risk of stroke due to AFib not caused by a heart valve problem.
No regular blood tests means no disruption to your routine
No dietary restrictions means you can continue to eat the foods you enjoy
Review the chart below, then talk to your doctor about whether PRADAXA is right for you
PRADAXA | warfarin* |
|---|---|
 BLOOD TEST (for monitoring) | |
No need for regular blood tests to see if your blood-thinning level is in the right range. | Requires regular blood tests to measure International Normalized Ration (INR) to see if your blood-thinning level is in the right range. |
 DIETARY RESTRICTIONS | |
No dietary restrictions. | Dietary restrictions required. You may need to limit many foods with vitamin K, such as leafy green vegetables and some vegetable oils. This is because vitamin K can affect the way warfarin works in your body. |
 REVERSAL TREATMENT | |
PRADAXA is a blood thinner with an FDA approved specific reversal treatment, available to your local hospital. | To reverse the effects of warfarin, vitamin K1 can be given. |
 DOSING STRENGTHS | |
Available in 2 dosage strengths for AFib not caused by a heart valve problem.† Available in 1 dosage strength for DVT and PE. Your doctor will decide which dose is right for you based on a simple kidney function test. | Available in 9 dosing strengths.‡ Dosage strength change may be required based on blood testing results. |
 DOSING SCHEDULE | |
Taken twice a day. | Taken once a day. |
It's important to know that PRADAXA can cause bleeding, which can be serious, and sometimes lead to death. This is because PRADAXA is a blood-thinning medicine (anticoagulant) that lowers the chance of blood clots forming in your body. Learn more about PRADAXA safety information.
"On warfarin, needing routine INR blood monitoring was very inconvenient and it became a long and extensive process. I asked my doctor to switch me to PRADAXA, with its twice a day dose schedule. PRADAXA requires no INR testing, which is much more convenient for me."
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*
Warfarin is also known as Coumadin® or Jantoven®.
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†
PRADAXA comes in 150 mg and 75 mg strengths.
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‡
Warfarin comes in 1 mg, 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, and 10 mg strengths.
Some important considerations you'll want to discuss with your doctor
There are different treatment options for your condition. One of these treatment options is PRADAXA. There is an overwhelming amount of information available regarding PRADAXA, and it can be confusing, but this site is here to help answer your questions. Be sure to discuss your questions with your doctor.
Important safety and side effects information
Because PRADAXA is available only by prescription, the decision to prescribe it is made by a healthcare professional after discussing a range of important considerations with the individual adult patient. These considerations include both the risks and benefits of PRADAXA, and any other conditions you may have or other medications you may be taking. When taking PRADAXA, you should also be aware of possible serious side effects. Click on the links below as you read to learn more.
For people taking PRADAXA for AFib not caused by a heart valve problem:
PRADAXA lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking PRADAXA, you may have increased risk of forming a clot in your blood.
For people taking PRADAXA for DVT/PE:
PRADAXA treats blood clots in the veins of your legs (DVT) or lungs (PE) and reduces the risk of them occurring again.
Do not stop taking PRADAXA without talking to the doctor who prescribed it for you. Stopping PRADAXA increases your risk of a blood clot forming in your body.
PRADAXA may need to be stopped, if possible, prior to surgery or a medical or dental procedure. Ask the healthcare provider who prescribed PRADAXA for you when you should stop taking it. Your healthcare provider will tell you when you may start taking PRADAXA again after your surgery or procedure. If you have to stop taking PRADAXA, your healthcare provider 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. This is because PRADAXA is a blood thinner medicine that lowers the chance of blood clots forming in your body.
You may have a higher risk of bleeding if you take PRADAXA and:
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, including:
aspirin or aspirin-containing products
long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
warfarin sodium
a medicine that contains heparin
clopidogrel bisulfate
prasugrel
if you have kidney problems and take dronedarone or ketoconazole tablets
Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one listed above.
PRADAXA can increase your risk of bleeding because it lessens the ability of your blood to clot. While you take PRADAXA:
you may bruise more easily
it may take longer for any bleeding to stop
Call your healthcare provider 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, feeling dizzy or weak
Take PRADAXA Capsules exactly as prescribed. Do not stop taking PRADAXA Capsules without first talking to the healthcare provider who prescribes it for you. Stopping PRADAXA may increase your risk of a thrombotic event (the formation of a blood clot in a blood vessel).
PRADAXA may need to be stopped, if possible, for one or more days before any surgery, or medical or dental procedure. If you need to stop taking PRADAXA for any reason, talk to the healthcare provider who prescribed PRADAXA for you to find out when you should stop taking it. Your healthcare provider will tell you when to start taking PRADAXA again after your surgery or procedure.
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).
In some people, PRADAXA Capsules can cause symptoms of an allergic reaction, including hives, rash, and itching. Tell your healthcare provider or get medical help right away if you get any of the following symptoms of a serious allergic reaction to PRADAXA Capsules:
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chest pain or chest tightness
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swelling of your face or tongue
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trouble breathing or wheezing
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feeling dizzy or faint
Common side effects of PRADAXA include:
indigestion, upset stomach, or burning
stomach pain
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of PRADAXA. For more information, ask your doctor or pharmacist and be sure to also access the Medication Guide.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
If you or a loved one would like to find out more about PRADAXA as a possible treatment option, take time to review the PARADXA Safety Information. Then use the Doctor Discussion Guide for an easy way to get the conversation started during your next office visit.
Talking to Your Doctor
Prepare with your FREE Doctor Discussion Guide
Asking the right questions is an important part of getting the most from your doctor’s visit. To help start the conversation, get a discussion guide specific to your condition here and bring it with you to your next appointment.
AFib
Download or get your FREE Doctor Discussion Guide via email, review it, then select the questions about AFib and PRADAXA you'd like to discuss with your doctor for your next appointment.
DVT or PE
Download or get your FREE Doctor Discussion Guide via email, review it, then select the questions about DVT/PE and PRADAXA you'd like to discuss with your doctor for your next appointment.
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 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 17 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, under each condition, you will find a list and brief description of each of these trials, studies, and reviews.
Pradaxa® (dabigatran etexilate) is a prescription medicine that is used to:
- reduce the risk of stroke and blood clots in adults who have a medical condition called atrial fibrillation that is 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) and lungs (pulmonary embolism) after you have been treated with an injectable medicine to treat your blood clots for 5 to 10 days.
- reduce your risk of blood clots from happening again in the veins of your legs and lungs after you have received treatment for blood clots.
PRADAXA is not for use in people with artificial (prosthetic) heart valves.
For people taking PRADAXA for atrial fibrillation: Do not stop taking PRADAXA Capsules without talking to the healthcare provider who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke. PRADAXA may need to be stopped, if possible, before surgery or a medical or dental procedure. Your healthcare provider 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 healthcare provider 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 had a serious allergic reaction to any of the ingredients in PRADAXA.
- 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 or ketoconazole tablets.
Call your healthcare provider or get medical help right away if you have any of these 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 healthcare provider should watch you closely for symptoms of spinal or epidural blood clots. Tell your healthcare provider 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).
Tell your healthcare provider about all your medical conditions, including if you have kidney problems, bleeding problems, stomach ulcers, or have antiphospholipid syndrome (APS).
Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if PRADAXA will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with PRADAXA.
Tell your healthcare provider if you are a female who is able to become pregnant. Talk with your healthcare provider about pregnancy planning during treatment with PRADAXA. Talk with your healthcare provider about your risk for severe bleeding from the uterus if you are treated with blood thinner medicines, including PRADAXA.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your breast milk. You should not breastfeed during treatment with PRADAXA Capsules. Talk to your healthcare provider about the best way to feed your baby during treatment with PRADAXA Capsules.
Take PRADAXA exactly as prescribed. It is important to tell your healthcare provider 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‑1088.
CL-PX-100064 06.28.2021