The blood thinner, Pradaxa, may cause excessive bleeding in patients and has no known reversal agent or antidote. Several families that have lost a loved one from Pradaxa are seeking legal action against the maker of Pradaxa. If you have lost a person that you love from exsanguination or excessive blood loss and that person was given Pradaxa, please feel free to send an e-mail message to Texas Pradaxa Exsanuination Lawyer and Deadly Blood Loss Lawyer Jason Coomer with your name & contact information or use our online form for a free case evaluation.
Blood Thinners, Anticoagulants, Pradaxa, and Warfarin
Anticoagulants more commonly referred to as blood thinners are designed to reduce blood clotting. Blood thinners are commonly used to treat or prevent blood clots including thrombosis of veins. Blood thinners are commonly prescribed to treat patients with superficial vein clots or superficial venous thrombosis (SVT) and patients with deep vein clots or deep venous thrombosis DVT. Treatments are usually designed to prevent clots into the lungs called a pulmonary embolism or strokes. Blood thinners are also commonly given to patients that are at risk for a stroke including people with an atrial fibrillation or an irregular heartbeat. An atrial fibrillation or irregular heartbeat increases the risk of stroke, which is many times higher in patients with an irregular heartbeat.
Pradaxa is an oral drug that is unique in that it blocks the clotting protein thrombin. It is FDA approved only for preventing artery clots & stroke in patients with the irregular heartbeat called atrial fibrillation. However, it may have been prescribed for treating and preventing DVT vein clots and pulmonary embolisms.
Pradaxa has been marketed as a new and improved blood thinner to replace existing successful blood thinners like Warfarin (Coumadin). Warfarin (Coumadin) is a traditional blood thinner that has been commonly used in the United States. Pradaxa has the usual side effects and health risks of other blood thinners which includes excessive bleeding. However, unlike older blood thinners such as Warfarin, Pradaxa has two important differences:
1) Pradaxa has no known reversal agent or antidote, and
2) There is no standard method with which to measure the anticoagulant effects of Pradaxa.
Further, there are allegations that the drug manufacturer may have been aware of certain dangers of the drug's use, but did not warn the public in a timely manner of these health dangers.
Pradaxa Was Approved on October 29, 2010 and Heavily Marketed To Replace Other Blood Thinners on Hospital Formilaries
Pradaxa (dabigatran etexilate mesylate) is a direct thrombin inhibitor anticoagulant, which became FDA-approved on October 29, 2010. Pradaxa reduces the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa is being marketed to be prescribed and used to replace existing successful blood thinners such as Warfarin (Coumadin). Within the first seven months after Pradaxa's approval, more than 250,000 patients were prescribed Pradaxa. In July 2011, Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) announced that Pradaxa (dabigatran etexilate mesylate) capsules had been added to hospital formularies at 49 of the top 50 cardiology and heart surgery hospitals in the United States. In other words Pradaxa was added as the drug of blood thinner of choice in formularies that insure about 90 percent of covered lives in the U.S.
Boehringer Ingelheim has successfully marketed Pradaxa as an improvement over other blood thinners. However, Pradaxa has already led to hundreds of reports of deaths and many other serious life-threatening injuries.
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On December 7, 2011, the Federal Food and Drug Administration (FDA) issued a FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)
The U.S. Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.
FDA Facts about Pradaxa (dabigatran etexilate mesylate)
Pradaxa (dabigatran etexilate) is a blood thinner that was approved by the U.S. Food & Drug Administration (FDA) in October 2010 to prevent blood clots in patients with atrial fibrillation.
A blood thinner (anticoagulant) known as a direct thrombin inhibitor. Approved to reduce the risk of stroke and blood clots (systemic embolism) in patients with non-valvular atrial fibrillation. Available as 75 mg and 150 mg oral capsules. From approval in October 2010 through August 2011, a total of approximately 1.1 million Pradaxa prescriptions were dispensed and approximately 371,000 patients received Pradaxa prescriptions from U.S. outpatient retail pharmacies.1
At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label (See Additional Information for Healthcare Professionals).
Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.
Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.
FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa. (See Data Summary). FDA is working closely with the manufacturer of Pradaxa (Boehringer Ingelheim) to evaluate the post-market reports of bleeding.
FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.
Additional Information for Patients
Pradaxa is an anticoagulant medicine that reduces the risk of blood clots forming in your body and causing a stroke. Having a stroke can cause permanent disability and death. Do not stop taking Pradaxa without talking to your healthcare professional. Stopping use of your blood thinner suddenly can put you at risk of a stroke. Be aware that while taking Pradaxa you may bruise more easily and it may take longer for any bleeding to stop.
Call your healthcare professional and seek immediate care if you develop any signs or symptoms of bleeding such as
unusual bleeding from the gums
nose bleeding that happens often
menstrual or vaginal bleeding that is heavier than normal
bleeding that is severe or you cannot control
pink or brown urine
red or black stools (looks like tar)
bruises that happen without a known cause or that get larger
coughing up blood or blood clots
vomiting blood or vomit that looks like coffee grounds.
Other symptoms of Pradaxa internal bleeding may include:
Tiredness and Lethargy, Joint pain or swelling
Headaches Dizziness Weakness
swelling of the arms, hands, feet, ankles or lower legs
Discuss any questions or concerns about Pradaxa with your healthcare professional.
Report any side effects you experience to your healthcare professional.
Additional Information for Healthcare Professionals
If you prescribe Pradaxa, carefully follow the approved indication and other recommendations, such as dosage and administration, in the professional drug label. Make sure your patients know the signs and symptoms of bleeding and when to seek care. Pradaxa is eliminated by the kidneys, therefore: Renal function should be assessed prior to treatment with Pradaxa to determine the appropriate dose. Renal function should be reassessed during treatment with Pradaxa if clinically indicated (fluctuating renal function, diuretic use, hypovolemia), and the dose should be adjusted following recommendations in the label.
There is no need for dosage adjustment in patients with mild to moderate renal impairment (creatinine clearance [CrCl] > 30 mL/min). These patients should be given a dose of Pradaxa 150 mg orally twice daily. For patients with severe renal impairment, follow the recommended doses: For patients with CrCl 15-30 mL/min, the recommended dose is 75 mg orally twice daily. Dosing recommendations for patients with a CrCl <15 mL/min or on dialysis cannot be provided.
Report adverse events involving Pradaxa to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.
Data Summary Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. In a large clinical trial (18,000 patients) comparing Pradaxa (dabigatran etexilate mesylate) and warfarin, major bleeding events occurred at similar rates with the two drugs. At present, the FDA is evaluating the post-marketing reports of serious bleeding in patients taking Pradaxa submitted to the Adverse Events Reporting System (AERS) database. While serious, even fatal events have been reported, the FDA is analyzing the events to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.
Complicating this analysis, many factors can influence whether or not adverse effects are reported, particularly the length of time a drug has been marketed, whether or not the adverse effect is described in the drug label, and the amount of publicity about an event or safety concern.
For patients with non-valvular AF, the main alternative to Pradaxa is warfarin. Because warfarin has been marketed for over 50 years and is well-known to cause bleeding, patients and healthcare professionals are not likely to report bleeding in association with warfarin. Thus, a simple comparison between Pradaxa and warfarin with respect to the numbers of post-marketing reports of bleeding is of limited value.
FDA is working with the manufacturer, Boehringer Ingelheim, to analyze the post-market reports for evidence of inappropriate dosing, use of interacting drugs, or other clinical factors that might lead to a bleeding event.
FDA is also using its Mini-Sentinel active surveillance system to compare new users of Pradaxa and warfarin with respect to the likelihood of being hospitalized for bleeding.
At this time, FDA believes the benefits of Pradaxa continue to exceed the potential risks when the drug is used appropriately following the approved drug label. FDA recommends that healthcare professionals continue to prescribe Pradaxa following the recommendations in the drug label.
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In September 2011, Pradaxa became the subject of an investigation in New Zealand after as many as five elderly Pradaxa patients reportedly died as a result of internal bleeding / hemorrhaging. Another 36 patients reportedly suffered bouts of serious internal bleeding / hemorrhaging. New Zealand media outlets reported that some families claimed the chain of events leading to their relatives' deaths began when they switched from warfarin to Pradaxa, and infections set in after their conditions had deteriorated to the point of hospital admission.
The New Zealand reports came weeks after regulators in Japan asked the maker of Pradaxa to notify doctors about potentially deadly bleeding / hemorrhaging in some Pradaxa patients. According to a letter sent to Boehringer Ingelheim by the country's health ministry, between March 14 and August11, 81 elderly patients taking Pradaxa suffered heavy bleeding / hemorrhaging, leading to five deaths. Japanese officials suggested that patients older than 70 may need a lower dose of Pradaxa. Bleeding / hemorrhaging is also a side effect of older blood thinners, such a warfarin. But warfarin bleeding can be treated with vitamin K. There is no antidote available for bleeding caused by Pradaxa and similar drugs, known as direct thrombin inhibitors.
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Texas Dangerous Drug Attorney Jason Coomer commonly works with other lawyers throughout Texas and the United States including Houston Pradaxa Lawyers, San Antonio Pradaxa Lawyers, Dallas Pradaxa Lawyers, Chicago Pradaxa Lawyers, Illinois Pradaxa Lawyers, and other Dangerous Drug Claim Lawyers. By sharing information and working together, his law firm and other firms throughout Texas are able to provide better representation for there clients.
If you have been given Pradaxa and have
suffered severe blood loss from internal bleeing or
hemorrhaging, or have lost a person that you love that
was given Pradaxa,
please feel free to e-mail Texas Pradaxa Lawyer Jason Coomer
with your name & contact information or
use our online form for a free case evaluation.