Treatment with a Blood Thinner

In this section, we will explore:

  • What are blood thinners?
  • Atrial fibrillation (AFib) and the
    risk of stroke
  • Deep vein thrombosis (DVT)
    and pulmonary embolism (PE)
    and their risks

Understanding
Blood Thinners

Blood thinners are often prescribed to reduce the risk of blood clots and stroke in people with atrial fibrillation (AFib) not caused by a heart valve problem, who are at high risk of blood clots. The name blood thinner can be misunderstood, as blood thinners don’t actually “thin” your blood. In fact, blood thinners work by lowering the chances of blood clots forming in your body.

There are two different types of blood thinners:

Anticoagulants lessen coagulation, or the process by which your blood clots. PRADAXA and warfarin fall into this category.

Antiplatelets prevent blood cell fragments (platelets) from sticking to the walls of your blood vessels and each other.

What’s the difference between warfarin and newer anticoagulants like PRADAXA?

About AFib & Risk of Stroke

Atrial fibrillation, or AFib, is the most common type of irregular heartbeat. It occurs when one or both of the upper chambers of the heart – called the atria – don’t beat the way they should.

An irregular heartbeat can cause blood to pool in the left atrium, where a blood clot can form. If that clot breaks away, it can travel to the brain, where it can cause a type of stroke called an ischemic (is-KEE-mic) stroke.

Symptoms of AFib

There aren’t always symptoms with AFib, and you may be unaware of your condition until a doctor discovers it during a physical exam.

But when there are symptoms, they can include:

  • palpitations
  • weakness
  • fatigue
  • reduced ability to exercise
  • lightheadedness
  • dizziness
  • confusion
  • shortness of breath
  • chest pain

AFib can put you at 5x greater risk of a stroke

The Signs of a Stroke

If you or your loved one has AFib, you’ll need to know the signs of stroke. By using the simple acronym F.A.S.T., you’ll be able to quickly recognize if your loved one may be suffering a stroke. That’s important because it could be a situation where seconds count.

Take a few minutes to commit this acronym to memory:

It’s important to work closely with your doctor to develop a treatment plan to help reduce your risk of stroke. Our Doctor Discussion Guide can help you ask the right questions to assist your doctor in deciding if PRADAXA is right for you.

FAST FACTS ABOUT AFIB & STROKES

  • AFib affects more than 2 million people in the United States
  • The odds of developing AFib increase with age
  • It’s estimated that AFib is the most common type of irregular heartbeat in people over the age of 65
  • Women with AFib face a 260% greater risk of stroke than men with AFib
  • Every year in this country, about 156,000 people have AFib-related strokes
  • AFib causes up to 1 in every 5 strokes
  • Some people with AFib may have no symptoms

PRADAXA reduces the risk of ischemic stroke due to AFib not caused by a heart valve problem

  • The most important way to reduce your risk of ischemic stroke due to AFib is by reducing the chance of blood clots forming
  • In a clinical trial, PRADAXA was proven superior to warfarin at reducing risk of ischemic stroke in patients with AFib not caused by a heart valve problem
  • Unlike warfarin, PRADAXA doesn’t require regular blood tests to see if your blood-thinning level is in the right range, and has no dietary restrictions

Start the conversation with your doctor about helping to reduce the risk of stroke with PRADAXA today.

About DVT and PE

Doctors often refer to deep vein thrombosis (DVT) and pulmonary embolism (PE) as a single condition known as VTE, which stands for venous thromboembolism. DVT and PE affect about 900,000 people in the United States every year, and are very serious conditions. In fact, PE is a medical emergency and can be fatal, but there are treatment options available and steps you can take to reduce the risk of recurrence.

DVT and PE diagram

Deep Vein Thrombosis (DVT)

DVT is a condition in which one or more blood clots form in one or more of the deep veins in your body. These clots form most often in the large veins of your legs or thighs.

PE diagram

Pulmonary Embolism (PE)

Pulmonary means “pertaining to the lungs,” and embolism refers to a clot that forms in one part of the body and travels through the blood stream to another part of the body.

PE is a condition in which one or more of the pulmonary arteries in your lungs become blocked. In most cases, this blockage is caused by blood clots that form in the legs due to DVT and then travel to the lungs.

DVT & PE: Do you know
the symptoms?

The symptoms of DVT

DVT and PE diagram

In about half of all cases, DVT occurs without any symptoms. When there are symptoms, they can include:

  • pain or swelling in the affected
    leg or thigh
  • skin of the affected area is
    warm to the touch
  • change in skin color of the
    affected area, such as redness

If you experience any of these symptoms, contact your doctor immediately.

The symptoms of PE

The symptoms of PE are serious and require immediate medical attention, as PE can be fatal. These symptoms include:

  • unexplained shortness of breath
  • chest pain that worsens when you
    cough or breathe deeply
  • coughing up blood
  • lightheadedness or dizziness
  • rapid pulse
  • sweating

Call 9-1-1 or seek emergency medical attention immediately if you develop signs or symptoms of PE.

FAST FACTS ABOUT DVT/PE

  • Deep vein thrombosis (DVT) and pulmonary embolism (PE) pose a serious risk to your health
  • When a blood clot enters your lungs, it becomes a pulmonary embolism
  • DVT can be life threatening, especially if it leads to a PE
  • DVT/PE cause about 300,000 deaths each year in the United States
  • Even if DVT doesn’t lead to PE, nearly half of all people with DVT can develop a lasting complication called post-thrombotic syndrome that results in damage to the affected vein in the leg
  • A history of PE increases the risk of high blood pressure in the lung arteries, called pulmonary hypertension

PRADAXA had higher rates of total bleeding vs. placebo (no treatment).

The goals of treating DVT and PE

The management of DVT and PE has two goals. One of these is treatment, which includes:

  • Stopping the clots from growing
  • Keeping the clots from breaking free, traveling to the lungs, and causing a PE

The other important goal of management is to reduce the risk of another DVT or PE.

Start the conversation with your doctor

  • In clinical trials, PRADAXA was proven as effective as warfarin in the treatment of DVT and PE in patients who have been treated with an injectable blood thinner for 5 to 10 days, and in reduction of the risk of recurrence
  • Unlike warfarin, PRADAXA doesn’t require regular blood tests to see if your blood-thinning level is in the right range, and has no dietary restrictions

Start the conversation with your doctor about helping to treat DVT and PE and reducing the risk of recurrence with PRADAXA today.

See more See less

What is PRADAXA?

Pradaxa® (dabigatran etexilate mesylate) capsules 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.

IMPORTANT SAFETY INFORMATION

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).

Tell your doctor 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 doctor if you are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your breast milk. You and your doctor should decide if you will take PRADAXA or breastfeed.

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‑1088.

CL-PX-100034 January 2019

Please see full Prescribing Information and Medication Guide.

See more See less

What is PRADAXA?

Pradaxa® (dabigatran etexilate mesylate) capsules 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.

IMPORTANT SAFETY INFORMATION

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).

Tell your doctor 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 doctor if you are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your breast milk. You and your doctor should decide if you will take PRADAXA or breastfeed.

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‑1088.

CL-PX-100034 January 2019

Please see full Prescribing Information and Medication Guide.