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.
IMMP studies are also subject to bias and under-reporting. The manufacturer of Pradaxa is sponsoring a number of ongoing studies to monitor the safety of Pradaxa. 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. 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. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist. This is because primidone can decrease the level of Pradaxa in your body, which puts you at an increased risk for getting a blood clot.
They may suggest different medications. Clopidogrel Plavix is a medication that works by preventing the platelets in your blood from clotting. This is because it may increase your risk for bleeding. NSAIDs are medications that are usually used to ease fever, swelling, and pain. The drug dronedarone Multaq can increase the level of Pradaxa in your body if you have kidney problems such as chronic kidney disease.
This can be dangerous, because if you have more Pradaxa in your body, you may have more severe side effects and an increased risk for bleeding. If you have kidney problems such as chronic kidney disease, you may need to avoid taking certain oral medications that treat fungal infections while using Pradaxa. Oral medications are drugs in pill, capsule, or liquid form that you swallow.
Taking an antifungal medication with Pradaxa may increase the level of Pradaxa in your body if you have kidney problems. And this rise in the Pradaxa level may increase the risk of bleeding or side effects. Examples of antifungal medications that people with kidney problems should avoid while taking Pradaxa include:. They may advise you to use an antifungal cream instead.
Rifampin can decrease the level of Pradaxa in your body. The effects of Pradaxa and other anticoagulants will combine and may increase the risk for side effects and bleeding. However, you should still check with your doctor or pharmacist before using any of these products while taking Pradaxa.
Using more than the recommended dosage of Pradaxa can lead to serious side effects. Because this medication makes it harder for your blood to clot, taking too much can make you bleed and be very serious. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them.
However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. In case of overdose, call the poison control helpline at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at Do not let anyone else take your medication.
Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital.
It is also important information to carry with you in case of emergencies. Dabigatran pronounced as da'' bi gat' ran. Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?
What side effects can this medication cause? What should I know about storage and disposal of this medication? Brand names. Other uses for this medicine. What special precautions should I follow? Before taking dabigatran, tell your doctor and pharmacist if you are allergic to dabigatran, any other medications, or any of the ingredients in dabigatran capsules or pellets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
Be sure to mention any of the following: dronedarone Multaq , ketoconazole Nizoral , and rifampin Rifadin, Rimactane, in Rifamate, in Rifater. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Your doctor probably will tell you not to take dabigatran.
If you become pregnant while taking dabigatran, call your doctor. Taking dabigatran may increase the risk that you will experience severe bleeding during labor and delivery. Unless your doctor tells you otherwise, continue your normal diet.
Dabigatran may cause side effects. Tell your doctor if any of these symptoms occur: stomach pain upset stomach heartburn nausea Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment: unusual bruising or bleeding pink or brown urine red or black, tarry stools coughing up blood vomiting material that is bloody or looks like coffee grounds bleeding from the gums frequent nosebleeds heavy menstrual bleeding bleeding from a cut that lasts longer than normal joint pain or swelling headache dizziness or feeling faint weakness hives rash itching difficulty breathing or swallowing chest pain or tightness swelling of the face, throat, tongue, lips, eyes, arms, hands, feet, ankles, or lower legs Dabigatran may cause other side effects.
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