What is Pradaxa?
Pradaxa, also known as dabigatran etexilate, is a medication that is used to prevent blood clots from forming in the body. It is a direct thrombin inhibitor, which means that it works by blocking the activity of thrombin, an enzyme that is necessary for blood to clot. Pradaxa was developed and is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
Pradaxa is primarily used to reduce the risk of blood clots and stroke in people with an irregular heartbeat known as atrial fibrillation. It is also approved for the treatment and prevention of deep vein thrombosis and pulmonary embolism.
Like all medications , Pradaxa can cause side effects. Some of the most common side effects of Pradaxa include stomach pain, nausea, and indigestion. In rare cases, Pradaxa can cause serious bleeding, which can sometimes be fatal.
Patients taking Pradaxa need to be monitored regularly to ensure that their blood is clotting properly. The medication is available by prescription only and is typically taken orally in capsule form.
Overall, Pradaxa is an important medication for preventing blood clots and reducing the risk of stroke in people with certain medical conditions. However, like all medications, it should be used only as directed by a healthcare professional and with careful consideration of the potential risks and benefits.
Frequently Asked Questions about pradaxa
Pradaxa® Indicated for Stroke Prevention/Blood Clots | Boehringer Ingelheim.
Pradaxa® is a type of blood thinner. It treats and prevents blood clots. It can also prevent a stroke if you have atrial fibrillation without a heart valve issue. You might take Pradaxa to prevent blood clots after an operation to replace your hip.
The 150 mg capsule for oral administration contains 172.95 mg dabigatran etexilate mesylate, which is equivalent to 150 mg of dabigatran etexilate, and the following inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid.
PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss (e.g., a drop in hemoglobin and/or hematocrit or hypotension). Discontinue PRADAXA in patients with active pathological bleeding [see Dosage and Administration (2.2)].
PRADAXA was introduced in 2010 as the first FDA-approved alternative to warfarin to reduce risk of stroke in atrial fibrillation (AFib) not caused by a heart valve problem. The approval was based on a clinical trial that included over 18,000 adult patients.
Pradaxa is very similar to Plavix, intended to prevent blood clots in patients with atrial fibrillation. The FDA approved Pradaxa in October 2010 with the understanding that it was supposedly safer than traditional blood thinners such as Warfarin.
Patients who take the blood thinner Pradaxa (dabigatran etexilate) are at risk for serious, uncontrolled bleeding. This can be fatal. Other potential serious side effects include heart attack and liver damage.
In clinical trials, PRADAXA was proven as effective as warfarin for treatment of DVT and PE in patients who had already been on an injectable blood thinner for 5 to 10 days.
Pradaxa is a prescription blood thinner. People use Pradaxa to lower the chance of stroke and blood clots. The U.S. Food and Drug Administration warns that suddenly stopping Pradaxa or missing doses may increase the risk of blood clots or stroke.
Dabigatran (Pradaxa) is a member of the relatively new class of antithrombotic drugs known as direct thrombin inhibitors (DTIs).
A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin.
With Pradaxa, the reported bleeding events are still being investigated by the FDA. The FDA is also investigating whether or not consumers need to be warned about any other Pradaxa dangers. The FDA recall has not been finalized, so Pradaxa is still available and on the market.
An “indirect comparison” between Pradaxa and Xarelto showed that at the highest doses, Pradaxa did a better job of preventing strokes than its competitor. At lower doses however, there was not a great deal of difference.
A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin.
Usually, Pradaxa is meant to be used as a long-term treatment. If you and your doctor determine that Pradaxa is safe and effective for you, you'll likely take it long term. However, in some cases, such as after a hip replacement, you may take Pradaxa for only a short period of time.
Usually, Pradaxa is meant to be used as a long-term treatment. If you and your doctor determine that Pradaxa is safe and effective for you, you'll likely take it long term. However, in some cases, such as after a hip replacement, you may take Pradaxa for only a short period of time.
