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The Blood Thinner Pradaxa May Cause Fatal Blood Loss, Internal Bleeding, Hemorrhaging, And Death: Persons Taking Pradaxa Should Be Aware of These Health Risks by Texas Pradaxa Lawyer, Texas Pradaxa Fatal Blood Loss Lawyer, Texas Pradaxa Hemorrhaging Death Lawyer, and Texas Pradaxa Death Lawyer Jason S. Coomer

Scientific evidence has recently confirmed that the the blood thinner, Pradaxa, may cause serious health problems including internal bleeding and hemorrhaging in certain populations of patients that may cause death.  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.

If you have been given Pradaxa and have suffered severe blood loss from internal bleeding or hemorrhaging, or have lost a person that you love from excessive blood loss and that person was given Pradaxa, please feel free to e-mail Texas Pradaxa Blood Loss Lawyer Jason Coomer with your name & contact information or use our online form for a free case evaluation.

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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.

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 a

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

Death

Discuss any questions or concerns about Pradaxa with your healthcare professional.

Report any side effects you experience to your healthcare professional and the FDA MedWatch program using the information in the “Contact Us” box at the bottom of the page.

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.
 

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