This alert applies only to Pradaxa dabigatran etexilate manufactured by Boehringer Ingelheim. Three clusters of case reports of oesophageal ulcer have been reported to Boehringer Ingelheim from around the world.
In addition, cases of positive re-challenge have been reported. Boehringer Ingelheim has updated the data sheet for Pradaxa. Medsafe continues to monitor the safety of Pradaxa, as for all medicines. 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. Pradaxa can interact with several other medications. It can also interact with certain supplements as well as certain foods. Different interactions can cause different effects.
For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.
Below is a list of medications that can interact with Pradaxa. Before taking Pradaxa, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take.
Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions. 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 important to tell your healthcare provider about all medicines prescription and over-the-counter , vitamins, and supplements you take.
Some important considerations you'll want to discuss with your doctor There are different treatment options for your condition. 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. 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.
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.
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. 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: chest pain or chest tightness swelling of your face or tongue trouble breathing or wheezing feeling dizzy or faint.
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