The most serious risk associated with Pradaxa is bleeding. Bleeding is a risk for all medicines that thin the blood including warfarin and aspirin. Patients should contact their doctor immediately if they experience any of the following: long or excessive bleeding, exceptional weakness, tiredness, paleness, dizziness, headache, unexplained bruising or unexplained swelling.
Medsafe generally does not place prescribing restrictions on medicines; historically this has only occurred in very rare cases where the potential for very serious harm had been identified. The patient's physician is best placed to decide on the choice of appropriate medicine and dose based on:. The overall risks and benefits of the medicine are outlined in the data sheet and in other material that has been published about Pradaxa see links in Question 8 below.
Since this medicine is used as a fixed dose for all patients Medsafe saw no reason to impose prescribing restrictions. In addition other anticoagulants have similar risks and are not restricted. Pradaxa dabigatran consumer medicine information CMI. The company who makes Pradaxa is continuing to investigate the safety of this medicine in clinical studies. Should these show any new safety issues, Medsafe will take appropriate action.
Healthcare professionals and consumers can report to CARM. If you think you have experienced an adverse effect after taking Pradaxa, please report this to CARM. More information on safety monitoring of medicines.
None of the reports received by CARM to date have identified any cases of fatal bleeding or death caused by dabigatran. In a number of reports of bleeding, the patient was taking other blood-thinning medicines.
In other reports, the patient was taking other medicines or had an ongoing medical problem that may also have caused the reported events. The number of reports received so far by CARM is not unexpected for a new medicine.
This is a recognised phenomenon and is described in the literature as the Weber effect. If you are concerned you are experiencing side effects to dabigatran, you should discuss these with your doctor.
Your doctor is in the best position to review your medication and decide if changes need to be made. CARM have received a number of reports of suspected adverse reactions to Pradaxa. As of 15 September , this included four reports where the patients had died. It is very important that patients should not stop taking any blood thinning medicine, unless on the advice of their doctor, due to the risk of experiencing a blood clot or stroke. Before Pradaxa was approved in New Zealand the company conducted clinical trials in more than 26, patients worldwide, including:.
The clinical trial data generated before Pradaxa was approved for use in New Zealand has also been reviewed by a number of other countries and Pradaxa is approved in the Australia, the United States, Canada, and Europe.
The full dataset for clinical trials conducted by the company was reviewed by Medsafe. Medsafe assessment reports for Pradaxa. IMMP studies can be useful in generating information on the real-world usage of medicines and can potentially detect previously unknown safety signals.
However, these studies also have weaknesses. IMMP studies lack a comparator group, meaning it is difficult to tell if adverse events being experienced by patients taking the monitored medicine are occurring more or less frequently than an alternative medicine such as dabigatran compared to warfarin.
In these studies , people took either warfarin or Pradaxa after being treated for 5 to 10 days with a blood thinner in injection form. The results showed that 2. In comparison, 2. In studies, Pradaxa was also effective at treating VTEs in children. These people had the clotting event 3 to 12 months ago and were treated for it. In this study, 1.
In comparison, 1. In another study , Pradaxa was compared with a placebo treatment with no active drug to help prevent DVT or PE in people who had one in the past.
These people were treated with a different anticoagulant drug for 6 to 18 months and then started taking Pradaxa or a placebo to prevent another DVT or PE. Researchers found that 0. In comparison, 5. In studies, Pradaxa was also effective at preventing VTEs in children. Pradaxa was studied to help prevent blood clots in people who had just had hip replacement surgery.
Researchers compared Pradaxa with enoxaparin Lovenox , which is an anticoagulant in injection form. DVTs occurred in 7. In comparison, DVTs occurred in 8. PEs occurred in 0. In addition to the uses listed above, Pradaxa may be used off-label.
Heparin-induced thrombocytopenia HIT is a condition that can occur after you take an anticoagulant called heparin. HIT causes thrombocytopenia , which is a decrease in the level of platelets in your blood. HIT is dangerous because it can lead to an increased risk of developing a blood clot.
Some studies show that Pradaxa may decrease the risk of clotting in people with HIT and may be safe to take when you have a low platelet count. This means that platelet counts were normal in 38 of 40 people.
The other two people had other conditions that may have caused a decrease in platelet counts. Pradaxa is available only as a brand-name medication. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be just as safe and effective as the original drug. Generics also tend to cost less than brand-name drugs. Pradaxa contains the active drug dabigatran.
As the active drug, dabigatran is the ingredient that makes Pradaxa work. Pradaxa can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Pradaxa. For more information on the possible side effects of Pradaxa, talk with your doctor or pharmacist.
They can give you tips on how to deal with any side effects that may be bothersome. Most of these side effects may go away within a few days or a couple of weeks. Call your doctor right away if you have serious side effects. You may wonder how often certain side effects occur with this drug. As with most drugs, some people can have an allergic reaction after taking Pradaxa.
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:. Call your doctor right away if you have a severe allergic reaction to Pradaxa. Older adults may have more side effects from Pradaxa than younger people. This group may bruise more easily than usual or have nosebleeds or bleeding gums. As you get older, the risk of bleeding or stroke occurring while taking Pradaxa increases.
However, even with the additional risk of bleeding or stroke, sometimes this medication is the best choice for you. They may switch you to a different medication or decrease the dose.
Pradaxa may increase your risk for bleeding. This is because the drug works by preventing your body from making clots. Pradaxa was compared with warfarin Coumadin in studies. People took either drug to treat a blood clot in their legs called a deep vein thrombosis DVT or a blood clot in their lungs known as a pulmonary embolism PE. About 1. Bleeding was considered a major bleeding event if it resulted in death, occurred in an organ, caused symptoms such as dizziness, or caused a decrease in the level of hemoglobin.
Hemoglobin is a protein found in red blood cells. Bleeding that was fatal occurred in 0. Tell your doctor if you have any of the following:. If left untreated, serious bleeding can be fatal. So if you have any of the above symptoms while taking Pradaxa, see your doctor right away.
Heartburn is a side effect that may occur with Pradaxa. Heartburn can cause you to feel pain or burning in your chest. This is due to acid from your stomach moving into your esophagus , a tube that runs from your mouth to your stomach.
In four studies , 7. This was compared with 5. They may be able to recommend some ways to reduce the acid buildup and help ease your symptoms. Pradaxa is a type of drug called an anticoagulant. Stopping the use of an anticoagulant such as Pradaxa sooner than advised may increase your risk for a blood clot. Pradaxa has a boxed warning for this risk. A boxed warning is the most serious warning that the FDA requires.
Pradaxa works by stopping blood clots from forming. This helps prevent blood clots that can lead to heart attacks , strokes , and death. This type of blood clot is possible only with spinal procedures such as spinal taps or if medication is injected into the spine column. Symptoms of a spinal or epidural blood clot may include back pain, tingling, weakness, and incontinence loss of control of your bladder or bowels.
Typically, your doctor will start you on a low dosage. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect. The following information describes dosages that are commonly used or recommended.
However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs. The dose of Pradaxa to decrease the risk of stroke or a blood clot in people with nonvalvular atrial fibrillation A-fib is usually mg twice a day. However, your doctor may give you a different dose depending on factors such as whether you have kidney disease.
If you have any questions about what dose is right for you, talk with your doctor. The dose of Pradaxa for adults to treat a current deep vein thrombosis DVT or pulmonary embolism PE is also mg twice a day.
A DVT is a blood clot that typically develops in your leg, and a PE is a blood clot that occurs in your lung. To prevent a deep vein thrombosis DVT or pulmonary embolism PE from occurring again in adults, the dose of Pradaxa is mg twice a day. Then the dose would increase to mg once a day. Your dose may need to be adjusted or you may need to stop taking Pradaxa for a few days before you have surgery.
Talk with your doctor about any surgeries that you plan to have and how to prevent bleeding. For these uses, Pradaxa should be taken twice daily. Pradaxa dosages for children are based on body weight in kilograms kg , as follows:.
This includes how many capsules the child will need to take to reach their full dose. For children with kidney disease, doctors may prescribe a different dosage than those listed above. If you have any questions about what dosage is right for your child, talk with your doctor. If you miss your scheduled dose of Pradaxa, be sure to take it as soon as you remember.
If your next dose is less than 6 hours away, skip the missed dose and continue on your schedule with the next dose. If you have any questions about when to take your next dose after missing a dose, talk with your doctor or pharmacist. A medication timer may be useful, too. Usually, Pradaxa is meant to be used as a long-term treatment. However, in some cases, such as after a hip replacement, you may take Pradaxa for only a short period of time.
Talk with your doctor about how long you should be using Pradaxa. Some bleeds, such as stomach bleeds, may become serious. However, there is a medication called idarucizumab Praxbind that you may take if you develop a bleed. Idarucizumab is a reversal agent. This means it reverses the action of Pradaxa and helps your blood to clot normally again.
Because Pradaxa stops your blood from clotting easily, you may be at an increased risk of bleeding if you have surgery while taking the medication. Usually, your doctor will consider stopping your Pradaxa treatment 1 to 5 days before you have a major surgery. The amount of time that you stop taking Pradaxa before a surgery depends on the procedure and your kidney function. However, sometimes emergency surgery is necessary. Other drugs are available that can treat or help prevent a blood clot.
Some may be a better fit for you than others. They can tell you about other medications that may work well for you. Note: Some of the drugs listed here are used off-label to treat these specific conditions. Other medications that may be used to decrease your risk of blood clots, prevent blood clots occurring again, or prevent clotting after surgery include:. You may wonder how Pradaxa compares with other medications that are prescribed for similar uses. Here we look at how Pradaxa and Eliquis are alike and different.
The active drug ingredient in Pradaxa is called dabigatran. The active drug ingredient in Eliquis is apixaban. Eliquis comes as a tablet that you swallow. The tablet can also be crushed and dissolved in water, water and dextrose sugar , or apple juice; or mixed with applesauce. In addition, the tablet can be dissolved in water and given through a nasogastric tube.
Pradaxa and Eliquis both contain anticoagulant blood thinning medications. Therefore, these medications can cause some similar side effects, but they can also cause some different ones. Below are examples of these side effects. These lists contain examples of mild side effects that can occur with Pradaxa, with Eliquis, or with both drugs when taken individually. This list contains examples of serious side effects that can occur with both Pradaxa and Eliquis when taken individually :.
These drugs have been compared in a retrospective study on non-valvular A-fib. In this case, a retrospective study is one that looks back in time to compare data from people with A-fib who took either Pradaxa or Eliquis.
This study showed that the people who took Pradaxa had a 1. In the Pradaxa group, there was a 0. Pradaxa and Eliquis are both brand-name drugs.
There are currently no generic forms of either drug. Brand-name medications usually cost more than generics. According to estimates on GoodRx. Like Eliquis above , the drug warfarin Coumadin has uses similar to those of Pradaxa. Warfarin, on the other hand, can be used in people with heart valve replacements. Warfarin comes as a tablet that you swallow. Your doctor may adjust your dosage based on blood tests. A small change in your warfarin dosage can greatly change how thin your blood is. Pradaxa and warfarin both contain drugs that help prevent blood clots.
These lists contain examples of mild side effects that can occur with Pradaxa, with warfarin, or with both drugs when taken individually. These lists contain examples of serious side effects that can occur with Pradaxa, with warfarin, or with both drugs when taken individually. A boxed warning is the most serious warning from the FDA.
Warfarin is also approved to reduce the risk of blood clots in people with A-fib and heart valve replacements. The use of Pradaxa and warfarin in treating nonvalvular A-fib has been directly compared in a clinical study. In the study, the rate of death from any cause was 3. In these studies , people took either warfarin or Pradaxa after being treated for 5 to 10 days with an anticoagulant in injection form.
Pradaxa is a brand-name medication. Warfarin is a generic medication called warfarin. Pradaxa is a type of drug called an anticoagulant, which is often referred to as a blood thinner. Pradaxa belongs to a class of medications called direct-acting oral anticoagulants, or DOACs. A medication class is a group of drugs that work in a similar way. DOACs are anticoagulants, and they work by blocking thrombin. This is an enzyme in your blood that helps blood clot. An enzyme is a protein that aids chemical changes in your body.
No, there are no foods that are known to interact with Pradaxa. With some other medications, such as warfarin Coumadin , there are foods that you need to watch out for. Certain foods can make warfarin not work as well and may put you at risk for blood clots.
Examples of these foods include broccoli, spinach, and black licorice. This is because the grapefruit can increase the level of Pradaxa in your body, which may increase your risk of having a bleed. Never stop taking Pradaxa without first talking with your doctor.
Stopping Pradaxa use before your doctor advises you to can increase your risk of blood clots or stroke. Ask your doctor if and when you should stop taking Pradaxa before having surgery. In certain situations, such as switching from Pradaxa to warfarin Coumadin , you may have to start taking warfarin a few days before stopping Pradaxa treatment.
They can help you determine when to take your last dose of Pradaxa and your first dose of the new medication. There are no interactions between Tylenol and Pradaxa. These medications are usually used to ease swelling and pain, and taking them with Pradaxa may increase your risk for bleeding. If you have a fever, pain, or swelling while taking Pradaxa, ask your doctor or pharmacist to recommend a treatment.
Not usually. This may help prevent you from bleeding too much during and afterward. Your dentist and doctor will discuss a safe length of time for you to stop taking Pradaxa. Storing Pradaxa in your pill box may expose the medication to moisture. This can cause it to not work properly and be dangerous to you.
So you should keep Pradaxa in its original bottle or blister package so the drug stays dry. This makes Pradaxa much more convenient to take. There are no major interactions between alcohol and Pradaxa. However, Pradaxa helps prevent blood clots, and alcohol can also prevent clotting from occurring.
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