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Pradaxa associated with significantly lower rates of fatal and traumatic intracranial haemorrhage compared with Warfarin A new analysis of the 18,113 patient, RE-LY trial highlights significantly lower rates of both fatal and traumatic intracranial haemorrhage (ICH) in patients treated with dabigatran etexilate (Pradaxa) 110mg and 150mg bid compared to those treated with well-controlled warfarin. As part of the primary safety endpoint, the analysis evaluated 154 intracranial haemorrhages that occurred in 153 patients during the trial, including bleeding sites, rates, risk factors, associated trauma, and outcomes. Results of this safety analysis were recently published online in Stroke: The Journal of the American Heart Association. Intracranial haemorrhage is mostly seen in older patients with atrial fibrillation (AF), and is one of the most devastating complications of anticoagulation therapy. In the RE-LY trial, Pradaxa 110mg bid and Pradaxa 150mg significantly reduced the rate of ICH by 70 per cent and 59 per cent respectively, compared to well-controlled warfarin.

Pradaxa, Minor Injuries & Internal Bleeding / Drug Injury Lawyers Minor injuries can cause serious complications and catastrophic results for patients taking Pradaxa, a brand name drug manufactured by the pharmaceutical company Boehringer Ingelheim. The blood thinner is prescribed to prevent blood clots that can lead to strokes in patients with certain types of heart rhythm abnormalities. But a minor injury such as a fall or other trauma can cause uncontrolled internal bleeding. The U.S. Food and Drug Administration (FDA) is evaluating reports of serious bleeding in patients taking Pradaxa to determine if they are occurring more commonly than would be expected. Pharmaceutical companies have a legal responsibility to make and market drugs that are safe and effective when used as directed.

Boehringer Ingelheim study shows safety benefits of Pradaxa 19 April 2012 00:00 in Pharmaceutical Company Product News Boehringer Ingelheim has published new clinical data that demonstrates the safety benefits provided by its atrial fibrillation therapy Pradaxa. A new analysis from the 18,113-patient RE-LY trial has demonstrated that Pradaxa is associated with significantly lower rates of fatal and traumatic intracranial haemorrhage compared to warfarin patients. Haemorrhages of this kind are among the most serious complications associated with anticoagulation therapy and are the leading cause of disability and death from bleeding related to treatment, particularly affecting older patients. Assessing the risk of intracranial haemorrhage is an important part of reviewing the benefit-risk profile of anticoagulation therapy, thus underlining the advantages offered by Pradaxa. Earlier this month, Boehringer Ingelheim received UK approval for its ischaemic stroke treatment Actilyse to be utilised in an expanded treatment window.

Pradaxa Causing Serious Bleeding: FDA to Conduct Safety Review The U.S. Food and Drug Administration (FDA) is reviewing reports that hundreds of patients taking Pradaxa (dabigatran etexilate mesylate) have suffered from serious bleeding events. This free video demonstrates the bleeding risks associated with Pradaxa. Some of the patients have reportedly died from the bleeding events and suffered other serious injuries.

Pradaxa Internal Bleeding Class Action Lawsuit Investigation Pradaxa (dabigatran) is a relatively new anticoagulant drug manufactured by Boehringer Ingelheim Pharmaceuticals. Pradaxa is in a class of drugs called Direct Thrombin Inhibitors, otherwise known as blood thinners or anticoagulants. It was approved by the FDA in October of 2010 as an anticoagulant drug that was superior to the prescription drug Coumadin (warfarin) because it allegedly required less monitoring of the patient and no, or very little, change of diet. However, users of the drug Coumadin (warfarin) who experienced abdominal bleeding could counteract those side effects by flushing their body with Vitamin K which allows their blood to clot normally once again, stopping internal bleeding. There is no similar solution available to address people who experience internal bleeding while taking Pradaxa.

Pradaxa Internal Bleeding Concerns Mount after Patient Dies Home > Legal News > Pradaxa Internal Bleeding Concerns Mount after Patient Dies After an elderly man died from a brain hemorrhage, the Journal of Neurosurgery has suggested that Pradaxa internal bleeding is largely irreversible. Pradaxa (dabigatran) is the first in a new class of blood thinners known as direct thrombin inhibitors.

New Blood Thinner Similar to Pradaxa: Risk of Internal Bleeding Home > Legal News > New Blood Thinner Similar to Pradaxa: Risk of Internal Bleeding Merck & Co. has introduced a new blood thinner which is in the same class as Pradaxa and Xarelto, which also poses an increased risk of potentially fatal internal bleeding. This new anticoagulant, Vorapaxar, appears to reduce the risk of a fatal heart attack or stroke by roughly 20% in patients who have already suffered a heart attack. However, according to clinical trial results presented in March at the meeting of the American College of Cardiology in Chicago, this drug nearly doubles the risk of internal bleeding.

California Pradaxa Attorneys 1inShare The blood-thinning drug Pradaxa (dabigatran) has been linked to a number of serious complications, including an increased risk of serious and in some cases, fatal, bleeding events. Boehringer Ingelheim, the company that manufactures Pradaxa, acknowledged in November 2011 that the drug was responsible for approximatley 260 deaths worldwide. Adverse Bleeding Events Persist Among Pradaxa Patients, Resulting in Serious Injury and Death 09 April 2012 Faith Anderson According to a new report submitted to the FDA by the Institute for Safe Medication Practices (ISMP), the controversial blood thinner Pradaxa may have been responsible for another 117 deaths during the second quarter of 2011. The ISMP released their quarterly report earlier this week on adverse event reports submitted by patients and healthcare providers throughout the United States between April and June 2011. In light of the frequency and severity of Pradaxa adverse events, the blood thinner holds the dubious title of being associated with more reported side effects than any other regularly monitored drug, even though the medication had been on the market for less than a year at the time. New Blood Thinner Pradaxa Associated With Bleeding Side Effects Pradaxa was developed by drug firm Boehringer Ingelheim and garnered FDA approval in October 2010 to prevent blood clots and stroke in patients with atrial fibrillation.

Pradaxa Overdose and Hemorrhages Report The blood thinner Pradaxa, (subject of 6 wrongful death US lawsuits), according to a new FDA report, may have been responsible for another 117 deaths during the second quarter of 2011. The Institute for Safe Medication Practices (ISMP) published their quarterly report (PDF) earlier this week on adverse event reports between April and June 2011. Pradaxa (dabigatran) is associated with more adverse reported cases than any other regularly monitored drug, the anticoagulant had been on the market for less than a year at the time.

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