Posts Tagged ‘Pradaxa’
Stephan Moll, MD writes (on Nov 7th, 2014)… A publication this week in the New England Journal of Medicine reports on a new reversal agent (PER977 = Aripazine = ciraparantag) that may be effective against a number of different new oral anticoagulants [ref 1]. Read the rest of this entry »
Stephan Moll, MD writes… Apixaban (Eliquis®) was approved by the FDA this week (Aug 21, 2014) for the treatment of DVT and PE. The approval covers (a) acute DVT/PE management and (b) the longer-term prevention of recurrent DVT/PE. Read the rest of this entry »
Stephan Moll, MD writes… Today the FDA approved Pradaxa (dabigatran) for the treatment of DVT and PE. Thus, two of the new oral blood thinners are now FDA-approved for the treatment of DVT and PE: Xarelto (rivaroxaban) and Pradaxa (dabigatran). Due to the design of the clinical trials that lead to the FDA approval, Pradaxa should NOT be given immediately when DVT or PE are diagnosed, but rather after 5-10 days of treatment with an injectable blood thinner (into the skin or a vein; such as Lovenox = enoxaparin; Fragmin = dalteparin; Innohep = tinzaparin; or heparin). A Clot Connect summary of the FDA approval status of the four big new oral blood thinners for the various indications is in this table. Pradaxa’s full medication package insert is here. Today’s press release from Boehringer-Ingelheim about the FA approval is here.
Disclosures: I have been a consultant for Boehringer-Ingelheim, Daiichi, and Janssen.
Last updated: April 7th, 2014
Stephan Moll, MD writes…
Interesting publication this week in Circulation: “Management and outcomes of major bleeding during treatment with dabigatran or warfarin” (Majeed A et al; published online Sept 30,2013; full publication is here). The management and prognosis of major bleeding in patients treated with dabigatran or warfarin was compared, pooling data of the major bleeds that occurred in 5 phase III dabigatran trials. 1,121 major bleeds occurred in 27,419 patients treated with warfarin or dabigatran. Read the rest of this entry »
Stephan Moll, MD writes…
1. Pradaxa (Dabigatran)
- Today, August 28th, 2013, it was announced that the FDA is reviewing the application by Boehringer-Ingelheim to get Pradaxa (dabigatran) approved for use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) – details here.
- At present, in the US, Pradaxa is only FDA-approved for prevention of stroke and other arterial clots in patients with irregular heart beat.
2. Eliquis (Apixaban)
- On July 11th , 2013 the company making Eliquis applied for FDA approval of their drug for DVT and PE prevention after hip and knee replacement surgery – details here.
- The company has not yet filed for approval of the drug for DVT and PE treatment.
- At present, in the US, Eliquis is only FDA-approved for prevention of stroke and other arterial clots in patients with irregular heart beat.
3. Xarelto (Rivaroxaban)
- Xarelto is, at present the only one of the new oral anticoagulants that is FDA-approved for the treatment of DVT and PE. It is also approved for (a) DVT and PE prevention after hip and knee replacement surgery, and (b) for prevention of stroke and other arterial clots in patients with irregular heart beat.
- This new oral anticoagulant by the Japanese company Daiichi is not FDA-approved at this time and no FDA review of data is pending, as far as I know, for any indication.
Disclosure: I have consulted for Janssen, Daiichi, Boehringer Ingelheim.
Last updated: Aug 28th, 2013
Stephan Moll, MD writes… The decision how long to treat a patient who has had a DVT or PE with blood thinners can often be made based just on the patient’s history. Often no testing for clotting disorders (thrombophilias) is needed. The decision how long to treat is influenced by 3 factors: (1) What is the person’s risk of another clot if he/she is not on blood thinners any more? (2) What is the person’s risk for bleeding on blood thinners? (3) What is the person’s own preference regarding his/her treatment. These issues are discussed in detail here.
However, if one were to do testing, what is the right time to test? It is important to know that some blood thinners can influence test results.
Xarelto (Rivaroxaban) was approved in Europe today (Dec 19th, 2011) for patients with acute DVT. This is good news on the path to have a blood thinner for patients with DVT available that is easier to deal with than Warfarin. Read the rest of this entry »
Beth Waldron, Program Director of the Clot Connect project, writes….
Approximately 1 in 5 people don’t take a medication a doctor has prescribed because they can’t afford to pay for it [ref 1]. While the cost of some outpatient “blood thinning” therapies (anticoagulants) can be substantial, failure to take a blood thinning medication as prescribed can have serious, even deadly, consequences.
What can you do when prescribed a blood thinner you cannot afford? Read the rest of this entry »
What topics do you need to discuss with your physican or anticoagulation clinic pharmacist or nurse when you are considering starting Pradaxa (Dabigatran)? A structured, bulleted checklist may be helpful for the discussion, to make sure that all relevant points are addressed. A suggested list is here. Read the rest of this entry »
If you are considering to start therapy with the new oral “blood thinner” Pradaxa®, there are a few safety nets that your local hospital and physician may want to establish to make therapy as safe as possible for you. Issues to be addressed are (a) dosing, (b) management of major bleeding, (c) interruption of therapy for surgery, dental procedures, or other procedures, d) what to do if you missed a dose, and (e) what to do if the pill box has been left open for too long.
These issues are probably best addressed by the establishment of a treatment algorithm/guide/help for the whole hospital or physician practice. As an example, attachedthat we developed for our institution, the University of North Carolina (UNC) Health Care System. Your physicians and pharmacists are free to (a) take the document and modify it to fit their institution/practice or (b) use it as a clinical reference for management issues.
For Health Care Professionals: This same post, written for health care professionals, is posted here.
Disclosure: I have no financial conflict of interest relevant to this educational post.
Last updated: May 1st, 2012
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