Some information you’ll want to know
You may have questions about your condition, and about taking PRADAXA. Below you’ll find some of the most common questions, along with answers.
PRADAXA & AFib
Many factors can increase your risk of developing atrial fibrillation (AFib) including:
- age. The older you are, the higher the risk of developing AFib
- heart disease
- high blood pressure
- chronic conditions such as thyroid problems, sleep apnea, metabolic syndrome, chronic kidney disease, or lung disease
- alcohol intake
- obesity
- personal or family history of AFib
AFib is a type of irregular heartbeat, and when your heart beats irregularly, blood can pool in the left atrium of your heart and a blood clot can form. If that clot breaks away, it can travel to your brain, blocking blood flow and causing a type of stroke called an ischemic (is-KEE-mic) stroke. People with AFib have a risk of stroke that is 5 times greater than those without AFib.
Yes, it is possible to have AFib without having any symptoms, and to be unaware of your condition until your doctor discovers it during a physical exam.
Since AFib can increase your risk of having a stroke, it’s important that you know the signs. F.A.S.T. is a simple way to remember the signs of stroke: Face drooping, Arm weakness, Speech difficulty, Time to call 9-1-1. Other signs of stroke include: severe headache, dizziness, loss of balance or trouble walking, confusion or trouble speaking/understanding, numbness or weakness on one side of the body or face, and blurry or darkened vision. Seek emergency medical attention immediately if these symptoms occur.
PRADAXA is a type of medication called an anticoagulant, or blood thinner, which means it lowers your chance of having a stroke by helping to prevent clots from forming.
Before you and your doctor decide if PRADAXA is right for you, you’ll want to talk about any possible side effects and other medicines that may affect the way PRADAXA works in your body. One of the most important things you will need to know about PRADAXA is that if you stop taking it, you increase your risk of having a stroke or forming blood clots. See Side Effects and Important Safety Information for more information.
PRADAXA & DVT/PE
Many factors can increase your risk of developing DVT (deep vein thrombosis) and pulmonary embolism (PE) including:
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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
In about half of all cases, DVT occurs without any symptoms. When there are symptoms, they can include:
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pain or swelling in the affected leg or thigh
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skin of the affected area is warm to the touch
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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 are serious and require immediate medical attention, because a PE can be fatal. These symptoms include:
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unexplained shortness of breath
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chest pain that worsens when you cough or breathe deeply
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coughing up blood
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lightheadedness or dizziness
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rapid pulse
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sweating
If you develop signs or symptoms of a PE, seek emergency medical attention immediately.
There are steps that you can take to help reduce your risk of recurrence of your condition:
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Continue taking your medication as prescribed
Take your medication as prescribed, and check in with your doctor on a regular basis to see if your medication or treatments need to be adjusted -
Just move
Ask your doctor when you should start to get up and move after surgery or illness. Movement can reduce your chances of developing blood clots -
Exercise your lower calf muscles
If you sit for long periods of time, get up periodically and walk around -
Take care of your overall wellness
Work with your doctor to determine if you need to lose weight, quit smoking, and keep your blood pressure in check -
Wear compression stockings
Discuss these with your doctor because they can help lower the chance of blood clots forming in your lower legs
PRADAXA is a type of medication called an anticoagulant, or blood thinner, which means it lowers your chance of blood clots forming in the veins of your legs (DVT) or lungs (PE) and reduces the risk of them occurring again.
Some facts about PRADAXA
There is no generic available for PRADAXA.
Unlike warfarin, with PRADAXA, there is no need for regular blood tests to see if your blood-thinning level is in the right range. See how PRADAXA compares to warfarin.
Unlike warfarin, PRADAXA has no dietary restrictions, so taking PRADAXA requires no change to your diet. See how PRADAXA compares to warfarin.
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