Category Archives: Pradaxa

Blood Thinners

If you took one of these blood thinners, and you have since suffered an irreversible gastrointestinal hemorrhage or another serious side effect, contact a reputable blood thinner injury lawyer to discuss your legal options. With an experienced attorney on your side, you can protect your legal rights and seek fair and timely reimbursement for your injuries and medical expenses.

What are Blood Thinners?

Blood thinners like Eliquis (apixaban), Pradaxa (dabigatran) and Xarelto (rivaroxaban) are prescription medications designed to reduce the risk of stroke and dangerous blood clots in patients diagnosed with atrial fibrillation, a medical condition characterized by an irregular heartbeat. Blood thinners work on chemical reactions in the body to lengthen the amount of time it takes to form a blood clot, which decreases the risk of heart attack and stroke by reducing the formation of blood clots in the arteries and veins. While some blood thinners, like warfarin, have an antidote that can be administered to reverse the blood-thinning effects of the drugs in the event of a bleeding complication., many new-generation blood thinners, like Eliquis and Xarelto, have no antidote.

Why are there Blood Thinner Lawsuits?

Product liability lawsuits brought against the makers of Eliquis, Pradaxa, Xarelto and other new-generation blood thinners allege that the manufacturing companies designed, manufactured and marketed defective medications, failed to adequately warn users about the risks associated with their blood thinner drugs, and overstated the benefits of their medications, while downplaying their risks. As a result, former users of Eliquis, Pradaxa and Xarelto across the country are now pursuing legal claims against the makers of the widely-used blood thinners, seeking compensation for medical bills, lost wages, emotional distress, and other economic damages.

Side Effects Linked to Blood Thinners

By thinning the blood, anticoagulant medications like Eliquis, Pradaxa and Xarelto can effectively reduce the risk of blood clots forming and traveling to the brain, which may cause a stroke, but they have also been linked to serious bleeding problems, often resulting in hospitalization or death. Some of the most common side effects of blood thinners include the following:

  • Internal bleeding requiring hospitalization
  • Cerebral hemorrhages
  • Gastrointestinal (GI) bleeding
  • Rectal bleeding
  • Kidney bleeding
  • Death

Links to Blood Thinner Studies Alleging Side Effects

A number of studies published in recent years have highlighted the potential side effects of popular blood thinners like Eliquis, Pradaxa and Xarelto, including research published in the British Medical Journal in April 2015, which found that patients taking Xarelto to reduce their risk of stroke and blood clots faced double the risk of gastrointestinal bleeding complications, compared to patients taking warfarin. In another study published in the medical journal Circulation: Cardiovascular Quality and Outcomes in January 2016, researchers found that while Pradaxa and warfarin offered similar stroke-prevention efficacy in patients with atrial fibrillation, the risk of gastrointestinal bleeding was higher for patients taking Pradaxa than for those taking warfarin.

When considering approval for the new-generation blood thinner Eliquis, the FDA relied heavily on a clinical trial conducted in China called ARISTOTLE, which compared the safety and effectiveness of the new-generation blood thinner to warfarin, an older medication that has been the go-to blood thinner in the United States for decades. It was only after Eliquis was approved in 2013, that it was discovered the ARISTOTLE clinical trial was heavily flawed, with reports accusing researchers of concealing Eliquis side effects from test results, losing participants, changing and falsifying records, and failing to report a study participant’s death.

Recent Blood Thinner News

In July 2015, the first Eliquis lawsuit was filed against Pfizer and Bristol-Myers Squibb, on behalf of Donald Herschell, a man who was prescribed Eliquis in 2014 to treat his irregular heartbeat. The lawsuit, filed in the Southern District of New York, alleged that, among other things, Pfizer and Bristol-Myers failed to provide adequate warnings about the risks associated with taking a blood thinner that doesn’t have an antidote. Just a few months after beginning treatment with Eliquis, Donald Herschell suffered an irreversible gastrointestinal hemorrhage and died in the hospital that same day.

Thousands of similar lawsuits have been brought against the makers of Pradaxa and Xarelto, two of the most widely-used blood thinners on the market, alleging that the prescription drugs increased the risk of serious and potentially life-threatening bleeding problems in users. In 2014, Pradaxa maker Boehringer Ingelheim agreed to pay $650 million to resolve more than 4,000 product liability lawsuits alleging gastrointestinal bleeding complications from Pradaxa, and that same year, more than 500 Xarelto lawsuits were consolidated for coordinated pretrial proceedings in the Eastern District of Louisiana, as part of a multidistrict litigation (MDL).

How Do I Join the Blood Thinner Lawsuit?

According to the FDA, all blood thinners are known to increase the risk of bleeding, but new-generation blood thinners like Eliquis, Pradaxa and Xarelto have been linked to a higher-than-expected risk of internal bleeding, which is further complicated by the lack of an antidote. If you or a loved one has suffered severe gastrointestinal bleeding complications, and you believe a blood thinner like Eliquis, Pradaxa or Xarelto to be the cause, contact an experienced product liability lawyer today for legal help. You may have grounds to file a lawsuit against the drug manufacturing company, in order to pursue the financial compensation you deserve for your injuries, medical bills, pain and suffering, and other damages.

Xarelto and Pradaxa Victims Encouraged by Previous Pradaxa Settlement

If you took Pradaxa or Xarelto in the past, and you have since suffered a major bleeding complication or another serious side effect as a result, consult an experienced product liability lawyer today for legal help. You may have grounds to file a Pradaxa or Xarelto lawsuit against the drug maker, in order to seek fair and timely reimbursement for your losses.

New-Generation Anticoagulant Drugs

Although Xarelto (rivaroxaban) and Pradaxa (dabigatran) have different active ingredients, both drugs belong to a new class of anticoagulant medications that have been hailed as a breakthrough treatment for patients whose only other option for fifty-plus years was warfarin. Unlike warfarin, which requires frequent blood tests to monitor how well the blood is clotting, and which has been the go-to blood thinner in the United States since the 1950s, Xarelto and Pradaxa were marketed from the very beginning as requiring less patient monitoring and carrying a lower risk of stroke and other side effects. What thousands of former Xarelto and Pradaxa users, many of whom have suffered life-threatening bleeding complications, now know, is that these claims are not entirely true.

Possible Side Effects of Pradaxa, Xarelto

Approved by the U.S. Food and Drug administration (FDA) in 2010 and 2011, respectively, Pradaxa and Xarelto have been prescribed to millions of patients across the United States who suffer from atrial fibrillation, a medical condition characterized by an irregular heartbeat. Just two years after Pradaxa came to market though, the blood thinner was blamed for more than 500 patient deaths and thousands of bleeding complications, and that same year, the FDA reported that patients taking Xarelto were three times more likely to suffer fatal side effects than patients taking warfarin. In 2014, federal regulators required the makers of Xarelto to update the drug warning label to reflect the increased risk of “serious or fatal bleeding” from Xarelto.

Reversing Pradaxa, Xarelto Bleeding Events

The main problem with Pradaxa and Xarelto lies in the fact that when the drugs first became available for consumer use, they did not have an approved antidote, designed to reverse the blood-thinning effects of the drugs in the event of a bleeding problem. A Pradaxa reversal agent called Praxbind was approved by the FDA in October 2015, but the move came far too late for former Pradaxa users who suffered devastating bleeding side effects from the anticoagulant drug, or to the family members who lost loved ones to fatal Pradaxa bleeding events. To this day, there is still no approved antidote for Xarelto, which means doctors may be unable to control bleeding complications in patients taking the blood thinner.

As former Pradaxa and Xarelto users across the country become aware of the potential for the new-generation anticoagulant drugs to cause severe and potentially life-threatening bleeding complications, Boehringer Ingelheim and Bayer face a growing number of product liability lawsuits alleging that they failed to adequately warn about the risks associated with the blood thinners. There have been more than 2,800 lawsuits filed over Xarelto side effects in federal courts across the country, all of which have been consolidated in an MDL overseen by U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, with the first trials set to begin in the spring of 2017.

Pursuing Compensation for Severe Bleeding Injuries

With a $650 million Pradaxa settlement agreement from Boehringer Ingelheim already in the books, it’s possible that Bayer will make a similar move and agree to settle the Xarelto product liability claims currently pending against the company. Contact the knowledgeable attorneys at the Monroe Law Group as soon as possible if you believe you have been adversely affected by bleeding complications of the controversial blood thinners Pradaxa or Xarelto.

There is no risk to you in consulting one of our lawyers today. Contact Monroe Law Group now by phone at 619-777-1234 or by email at intake@monroelawgroup.com to arrange for your free, no-obligation consultation.

FDA Approval of Pradaxa Reversal Agent is Too Late for Many Bleeding Victims

If you believe you have been harmed by uncontrollable bleeding side effects of Pradaxa or other devastating injuries, consult an experienced Xarelto/Pradaxa internal bleeding attorney today for legal help. You may be entitled to financial compensation for your bleeding injuries, hospital bills, lost wages, pain and suffering and other damages, which you can pursue by filing a Xarelto or Pradaxa bleeding lawsuit today.

Pradaxa and Xarelto Blood Thinners Used by Millions

When Pradaxa (dabigatran) first came to market in October 2010, it was aggressively marketed by its manufacturer, Boehringer Ingelheim, as a superior alternative to warfarin, which has been the go-to anticoagulant in the United States for decades. According to Boehringer, Pradaxa requires less patient monitoring during treatment and reduces the risk of strokes and other side effects, and many patients were switched to the new-generation blood thinner as a result of these claims. In 2011 alone, Boehringer Ingelheim spent $464 million to promote Pradaxa, and by August 2012, more than 3.7 million patients in the United States had filled prescriptions for the blood thinner.

Lawsuits Alleging Bleeding Injuries from Pradaxa and Xarelto

Perceived by many as a safe and effective anticoagulant drug, Pradaxa actually carries a serious risk of side effects, including hemorrhaging and uncontrollable internal bleeding, and just two years after its arrival on the market, the blood thinner was blamed for more than 500 patient deaths. It was stated that in 2011 alone, the FDA received 817 reports of adverse events involving Pradaxa, but a QuarterWatch report released that same year identified 3,781 serious adverse events from Pradaxa in 2011, 542 of which were fatal.

Thousands of victims of Pradaxa bleeding complications have taken legal action against Boehringer Ingelheim, filing product liability lawsuits alleging that the drug maker failed to adequately warn consumers and the medical community about the potential for Pradaxa to cause severe and potentially life-threatening bleeding problems. In May 2014, Boehringer settled more than 4,000 of these claims, agreeing to pay $650 million to resolve all of the Pradaxa multidistrict litigations (MDLs) that had been created.

FDA Approves Pradaxa Reversal Agent

It wasn’t until October 2015, that the U.S. Food and Drug Administration (FDA) finally approved a reversal agent called Praxbind (idarucizumab) as the first antidote for this new class of blood thinners, indicating that the drug can be used to safely reverse the blood-thinning effects of Pradaxa in the event of a bleeding complication. It is hoped that, as Praxbind becomes more widely available, the number of potentially life-threatening bleeding injuries from Pradaxa can be significantly reduced. According to one study published in the New England Journal of Medicine in June 2015, Praxbind may be able to stop Pradaxa’s blood-thinning effects within minutes, allowing doctors to treat bleeding side effects that occur among users. To this day, Xarelto still does not have an approved reversal agent, yet continues to be prescribed.

An Experienced Pradaxa Attorney Can Help

In the meantime, Boehringer Ingelheim has faced significant criticism and a number of lawsuits claiming that the drug manufacturing company never should have been allowed to sell Pradaxa without a reversal agent in the first place, and victims of Pradaxa bleeding complications may be entitled to financial compensation from Boehringer for their injuries and medical expenses. If you or a loved one took the anticoagulant Pradaxa in the past, and you have since suffered an uncontrollable bleeding side effect, contact the knowledgeable Pradaxa/Xarelto attorneys at the Monroe Law Group today at 877-834-5431, at intake@monroelawgroup.com, or by completing the form on this page to discuss your legal options. With a reputable product liability lawyer on your side, you can protect your legal rights and seek fair and timely reimbursement for your medical bills, losses, and/or pain and suffering.

Pradaxa Blood Thinner Linked to Bleeding Injuries, Heart Attack/Stroke

Have you or a loved one suffered any of these conditions during or after Pradaxa treatment?

When Pradaxa was approved by the U.S. Food and Drug Administration (FDA) in 2010, it was indicated to prevent strokes and harmful blood clots in patients with a heart condition called atrial fibrillation, which is characterized by an irregular heartbeat that can cause blood to pool in the heart’s upper chamber. By 2012, just two years after Pradaxa entered the market in the United States, more than 3.7 million U.S. patients had filled prescriptions for the blood thinner. Unfortunately, around that same time, Pradaxa treatment was blamed for more than 500 patient deaths. According to adverse event reports, using Pradaxa may result in an increased risk of the following side effects:

  • Internal or external bleeding requiring hospitalization
  • Heart attack
  • Stroke
  • Wrongful death

Did a medical doctor confirm your condition or diagnosis?

Atrial fibrillation affects more than two million Americans, and people with this condition have a nearly five-times increased risk of suffering a stroke than other people, which is why they are often prescribed blood thinners like Pradaxa. However, reports from healthcare professionals, federal regulators and respected medical journals indicate that the potential health risks of Pradaxa treatment may outweigh any possible benefits of the medication, and Pradaxa users who have suffered bleeding or other problems while taking the anticoagulant drug are advised to seek immediate medical attention to obtain an official diagnosis.

Are you currently represented by an attorney regarding this matter?

According to the Institute of Safe Medication Practices’ (ISMP) QuarterWatch report, the FDA received 817 reports of adverse events tied to Pradaxa therapy in 2011 alone. However, the incidence of uncontrollable bleeding and other complications from Pradaxa is believed to be underreported, and, according to additional reports from manufacturers, health professionals and medical databases, Pradaxa was associated with a total of 3,781 adverse events in 2011, 542 of which were fatal. When it comes to pursuing financial compensation for alleged Pradaxa side effects, it is imperative that you enlist the help of a qualified product liability lawyer, to improve your chances of winning your case.

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Former Pradaxa users across the country are pursuing legal claims against Boehringer Ingelheim, and in May 2014, the pharmaceutical drug company settled more than 4,000 Pradaxa lawsuits for $650 million. If you or a loved one has suffered uncontrollable bleeding, heart attack, stroke, or another devastating side effect, and you believe Pradaxa treatment to be the cause, contact the Pradaxa litigation attorneys at the Monroe Law Group today to discuss your legal options. You may have grounds to file a Pradaxa lawsuit against Boehringer Ingelheim, in order to seek reimbursement for your medical expenses, loss of income, pain and suffering, and other related damages.

There is no risk to you in consulting one of our lawyers today. Contact Monroe Law Group now by phone at 619-777-1234 or by email at intake@monroelawgroup.com to arrange for your free, no-obligation consultation.