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What Is Pradaxa?
- is a drug approved to reduce the risk of stroke and other blood-clot-related conditions primarily in patients with atrial fibrillation (Afib)
- is manufactured by German company Boehringer Ingelheim
- has the active ingredient dabigatran
- is a direct thrombin inhibitor
- was the first drug approved in the US to compete with warfarin
How Does It Work?
Pradaxa inhibits the function of thrombin, an enzyme crucial to the formation of blood clots.
Most patients prescribed Pradaxa have a condition called atrial fibrillation: an abnormality in the heart’s natural pacemaker causes episodes of chaotic, unsynchronized heart beats.
Prescriptions For Atrial Fibrillation
During an episode of Afib, the heart’s upper chambers, or atria, begin to beat out of sync with the chambers below, or ventricles. Usually, the rhythm returns to normal shortly.
But sometimes, the atria’s chaotic beating allows blood to pool in the chambers, rather than being pumped out with every beat. Over time, this stagnant reservoir of blood can clump together, forming a blood clot.
If the clot is pumped out toward the body, it can block blood vessels, reduce blood flow to vital organs or even cause a stroke. Pradaxa was designed to prevent that.
By “knocking out” an enzyme that leads to clot formation, the drug’s active ingredient, dabigatran, stops clots before they can develop and cause complications down the road.
Is The “Solution” A Potential Problem?
Clots aren’t always bad. In fact, sometimes they’re lifesavers.
A common result of external trauma is an internal injury. When blood vessels become damaged inside the body, they start to leak fluid into surrounding tissues.
But for many people, internal bleeding is manageable. Specialized cell fragments called platelets come along and, accompanied by thrombin, form a tight seal over the damaged vessel.
This seal, a blood clot, reduces the rate of bleeding and gives the vessel time to heal itself. Crisis averted.
Patients on Pradaxa, along with other new anticoagulants like Eliquis and Xarelto, are working at a disadvantage in this situation. With their body’s natural clotting ability inhibited, they have no way to stop the bleed. That can be fatal if left untreated.
Thousands Of Deaths, Serious Injuries
Sales of Pradaxa launched in October 2010. Initially approved to reduce the risk of stroke only in patients with atrial fibrillation (Afib), the drug’s approval would eventually be extended to cover the treatment and prevention of deep vein thrombosis and pulmonary embolism, as well.
On the back of those approvals, Pradaxa prescriptions ballooned until more than 850,000 Americans were taking the drug.
But without an effective reversal agent, patients soon began suffering debilitating bleeding events. To date, over 1,000 deaths have been ascribed to bleeding events aggravated by Pradaxa.
Severe Bleeding Events Overwhelm FDA Reporting System
According to QuarterWatch, a publication of the Institute for Safe Medication Practices, the drug racked up 932 severe adverse event reports in the first quarter of 2011 alone.
Analyzing data submitted to the FDA, QuarterWatch found 505 cases of hemorrhage, “more than any other monitored drug including warfarin,” a blood thinner that has been used for more than 50 years and can be effectively reversed in the case of emergency.
Gastrointestinal bleeding was particularly prevalent, with at least 293 total cases.
The independent drug safety watchdog identified 120 deaths, 40 per month, linked to Pradaxa. More than half of these deaths were explicitly caused by uncontrollable bleeding. Another 543 patients required hospitalization. Patients 80 years of age and older appeared to be most at risk.
Irreversible Bleeding Sparks Torrent Of Pradaxa Claims
Lawsuits came soon after. By 2014, thousands were filed, claiming Boehringer Ingelheim had concealed Pradaxa’s severe bleeding risks from patients and failed to adequately warn physicians that the drug’s effects could not be reversed.
With a preliminary “bellwether” trial close on the horizon, Boehringer agreed to settle almost 4,000 lawsuits for a total of $650 million.
But many legal experts believe the litigation is far from over.
More Patients May Be Eligible To File Lawsuits
Patients who suffered major bleeding events while taking Pradaxa may still be eligible to file a claim against Boehringer Ingelheim.
Banville Law is currently investigating potential Pradaxa claims. Our experienced attorneys offer a free consultation to any patient who believes Pradaxa may have contributed to a major bleeding event.
Latest Pradaxa Updates
By Laurence P. Banville
Pradaxa the "new generation" anticoagulant has been associated with the risk of excessive bleeding. Below you will find regular Pradaxa news, as well as lawsuits that are being filed in connection with the drug.
June 29, 2018 – Boehringer Ingelheim And Medisafe Partner To Support Pradaxa Users
Medisafe announced a partnership with Boehringer Ingelheim this month to provide Pradaxa patients in the U.S. with a medication management platform. Medisafe is a personalized mobile health platform for medication management which will now be available in the form of an app for Pradaxa patients to use for support and resources.
May 29, 2018 – Second Pradaxa Bellwether Trial Is A Win For Boehringer Ingelheim
On Monday, May 7, the second bellwether trial in the consolidated Connecticut state Pradaxa cases resulted in the jury returning a verdict in favor of Pradaxa manufacturers, Boehringer Ingelheim. The Hartford Superior Court jury found that the plaintiff did not prove her claim that the drug manufacturers were negligent in failing to warn consumers and the medical community of the potential risks associated with the drug that allegedly caused the plaintiff to be hospitalized from a gastrointestinal bleed.
April 25, 2018 – Reversal Agent For Pradaxa Receives Full FDA Approval
On April 17, Boehringer Ingelheim, the makers of the anticoagulant, Pradaxa, announced that the FDA has given full approval for Praxbind which is the specific reversal agent for the drug. The reversal agent had already received an accelerated approval by the FDA in October 2015 and the FDA stated that the drug would receive continued approval but that would be contingent upon the results of the phase III RE-VERSE AD trial. The trial showed that the reversal agent did reverse the effect of Pradaxa with no adverse safety signals being observed.
March 9, 2018 – Boehringer Ingelheim Will Announce Results Of Research On Pradaxa Reversal Agent
Boehringer Ingelheim, the makers of blood thinner Pradaxa, announced on March 9, that the analyses of several major trials will be presented on March 10 – 12 at the American College of Cardiology 67th Annual Scientific Session. The event will be held in Orlando, Florida and will cover information regarding the anticoagulant Pradaxa and its reversal agent Praxbind.
February 28, 2018 – Study Shows That Pradaxa And Other Anticoagulants Could Increase Stroke Risk
Researchers from the UK published a study in The BMJ medical journal recently that indicated that anticoagulants could increase the risk of stroke for afib patients with chronic kidney disease rather than reducing it. The study looked at the data of 6,977 patients with atrial fibrillation. Out of those patients, 2,434 patients were prescribed a blood thinner to reduce the risk of stroke within the first 60 days of their diagnosis. This included both vitamin k agonists such as warfarin and direct oral anticoagulants like Pradaxa. The patients on blood thinners who had chronic kidney disease had more than double the risk of suffering an ischaemic stroke.
January 19, 2018 – New Anticoagulant Outperforms Pradaxa In Korean Market
Lixiana is one of the newer oral anticoagulants, that replaces Warfarin, to enter the market in Korea. This drug is manufactured by Daiichi Sankyo and data is showing that it is outperforming Boehringer Ingelheim’s Pradaxa. The number of prescriptions is surging for Lixiana, with numbers of monthly prescriptions increasing by 19.8% in November. The current market leader for non-vitamin K antagonist oral anticoagulants is Xarelto with 3.55 billion prescriptions in November which is manufactured by Bayer Korea.
December 28, 2017 – Protests In Korea Regarding Pradaxa Maker’s Early Retirement Program
Boehringer Ingelheim’s Korean unit announced on December 12, their plan for an early retirement program for 49 employees in the cardiovascular diseases department. The decision to disintegrate the unit was made partially due to the underperformance of two of their drugs, Twynsta and Pradaxa. The company revoked the sales rights for Pradaxa last year. The labor union received notice only two days prior to their announcement which they state is a violation of their bargaining rules. They should have been notified 50 days prior.
November 30, 2017 – Results Of New Analyses Of Praxbind Released
On November 13, 2017, Boehringer Ingelheim released the results of two analyses of the phase III RE-VERSE AD study which evaluated the safety and effectiveness of Praxbind, the reversal agent for anticoagulant Pradaxa. These results were presented in Anaheim, California at the American Heart Association Scientific Sessions 2017. The results showed that idarucizumab, or Praxbind, was effective at reversing the effects of the anticoagulant in minutes so that emergency interventions could take place if necessary.
October 19, 2017 – Pradaxa And Other New Generation Anticoagulants Found To Have Increased Bleeding Risks When Taken With Certain Drugs
On October 3 a study on new generation anticoagulants and bleeding risks when used simultaneously with other drugs was published in the Journal of the American Medical Association. Safety concerns have circulated regarding these new blood thinners since their release a few years ago, yet they have been heavily marketed as needing less monitoring than the other more established anticoagulants such as warfarin. The researchers discovered that the newer blood thinners such as Pradaxa posed a greater risk of bleeding when taken at the same time as amiodarone, Rifadin (rifampin), Diflucan (fluconazole), or Dilantin (phenytoin).
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September 22, 2017 – Report Determines Anticoagulants To Be Linked To The Highest Number Of Prescription Medication Injuries
A report was recently published by the Institute for Safe Medication Practices (ISMP), which analyzed CDC data, and concluded that the prescription medication most likely to result in an emergency room visit is anticoagulants, such as Pradaxa. The data showed almost 22,000 severe injuries, including over 3,000 deaths, were related to blood thinners last year. Almost half of those injuries required a hospital stay. Even worse, the CDC reports that the number of injuries from blood thinners could be far greater because the FDA only tracks voluntary reports.
August 31, 2017 – Pradaxa Lawsuit Filed By Mississippi Woman
A new Pradaxa lawsuit has been filed against Boehringer Ingelheim Pharmaceuticals by a Mississippi woman claiming that the company failed to provide adequate warnings of the risks present when taking the anticoagulant. In her complaint, she claims that the severe gastrointestinal bleed which she suffered on April 11, 2016, was caused by Pradaxa. The plaintiff requests a trial by jury and is seeking compensation for her damages. This is not the first time the drugmaker has faced lawsuits regarding the blood thinner Pradaxa. In 2014, the company faced multidistrict litigation in the Southern District of Illinois over the drug, which they settled for $650 million.
July 26, 2017 – Results Of Pradaxa Reversal Agent Study Released
The REVERSE-AD results were released by Boehringer Ingelheim on July 11 and published in the New England Journal of Medicine. The study shows that Praxbind was effective at completely reversing the effects of the blood thinner, Pradaxa. There were no serious adverse safety signals observed in the study, and Praxbind is the only approved reversal agent for SGLT2 inhibitor anticoagulants.
June 27, 2017 – Family Of Deceased Man Files Pradaxa Lawsuit
After the death of a man in November 2012, his family is suing Boehringer Ingelheim Pharmaceuticals Inc. for wrongful death. The deceased man had fallen and suffered uncontrollable bleeding and his doctors attribute his use of Pradaxa to his death. There was previously a $650 million Pradaxa settlement over the fatal bleeding risks when taking the blood thinner but the plaintiffs did not partake in this settlement. They argue that the pharmaceutical company’s widespread discovery misconduct should carry over into this case. The case is scheduled to go to trial this month.
May 22, 2017 – Many FDA-Approved Drugs Have Unexpected Side Effects
Quite frequently drugs which have been approved by the FDA end up having side effects which are discovered years after their approval. Some of these side effects can be life-threatening. A new study was conducted which analyzed 222 prescription drugs FDA-approved between 2001 – 2010, including blood thinner Pradaxa. The results were published in the Journal of the American Medical Association, and the study’s lead author, Dr. Joseph Ross stated that “the large percentage of problems was a surprise.” The researchers for this study analyzed FDA online data on the drugs and the safety announcements made and discovered that most new side effects were discovered about 4 years after the release of a drug.
April 27, 2017 – Tentative Approval Given For Generic Form Of Pradaxa
The U.S. Food and Drugs Administration granted tentative approval on Wednesday, April 19, to drugmaker Glenmark to sell the generic form of Pradaxa. This is significant for the company which is aiming to grow and launch new products in the United States. This marks the fourth U.S. approval since January for Glenmark. Meanwhile, lawsuits continue to be filed by patients who allege that the manufacturer of the anticoagulant, Boehringer Ingelheim, failed to warn consumers of the severe bleeding risks associated with the drug.
March 3, 2017 – Daughter Of Deceased Pradaxa Patient Comments On Drug
An 84-year-old woman learned about Pradaxa through a “patient familiarisation program” and quickly jumped at the opportunity to take a new anticoagulant over her usual warfarin. Sadly, within a short time of beginning Pradaxa, the woman developed a bleed which caused her to be hospitalized twice. Due to these complications, she chose to switch back to warfarin but it would seem that decision was made too late. Her daughter stated that she found her underneath the dining room table attempting to crawl to the phone. She believes her mother suffered a massive stroke and wishes she had never heard of Pradaxa. While it is still not clear if Pradaxa played a part in her mother’s death, she believes she would still be alive today had her mother not used the new anticoagulant.
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February 15, 2017 – Pradaxa And Other New Anticoagulants Are Found To Be Heavily Marketed To Doctors
According to an ABC investigation, in just six months during 2015 pharmaceutical companies spent over $2.6 million on new blood thinner “educational events.” Some of the expenses are rather extravagant and at least one doctor, Dr. Mintzes, believes that the events contain a substantial amount of marketing rather than being all education-based. This has raised some concerns as to whether these drugs are being overly prescribed. Pradaxa, Eliquis, and Xarelto are a more convenient alternative to what used to be the only anticoagulant available, warfarin. These drugs, however, are not without risks. Evidence suggests that they are being prescribed more frequently and to lower-risk patients.
January 27, 2017 – Need For Reversal Agent For Anticoagulants Remains Unmet
The new generation of anticoagulants are called Factor Xa Inhibitors and have been developed as a replacement for the traditional blood thinner warfarin. While warfarin has a reversal agent in vitamin K in the event of a life-threatening bleed almost all of the new blood thinners currently lack an FDA-approved antidote. Anticoagulants such as Pradaxa have several lawsuits filed against manufacturers alleging personal injury or death from side effects suffered from the drugs. According to a Portola Pharmaceuticals sponsored article, mortality related to FXa-associated bleeding is seen in realworld registry data. The use of FA inhibitors continues to rise as the need for a reversal agent remains unmet. Many are hopeful that a reversal agent will be approved in 2017.
December 27, 2016 – Pradaxa Could Cause Bleeding Complications With Certain Statins
A new Canadian study suggests that patients who use Pradaxa and certain other statin medications could increase their risk for serious bleeding events. Many A-fib patients take a blood thinner medication to reduce their risk of strokes caused by clots. Dr. Kevin Marzo, the chief of cardiology at Winthrop-University Hospital in Mineola, N.Y., stated that “As many as 50 percent of patients on [Pradaxa] also are taking a statin.” Dr. Andrew Rogove a medical director of stroke at Northwell Health’s Southside Hospital in Bay Shore, N.Y.. stated that “The authors have identified a potentially serious problem” and pointed out that there are alternate statins that don’t affect Pradaxa in the same way.
November 18, 2016 – New U.S. Headquarters For Boehringer Ingelheim
The animal health U.S. headquarters for Boehringer Ingelheim Vetmedica Inc will be relocating to Duluth, Georgia, a suburb of Atlanta, from St. Joseph. President and CEO, Dr. Albrecht Kissel announced that the company will become the “second largest animal health player in the world” as they integrate with Sanofi’s animal health business. The company is already a leading U.S. pharmaceutical manufacturer, producing prescription drugs such as Pradaxa, an anticoagulant for humans.
October 28, 2016 – Summary Judgment Denied, Pradaxa Lawsuit Can Continue To Trial
Boehringer Ingelheim had filed a motion for summary judgment regarding a wrongful death case over the side of effects of the blood thinner Pradaxa, which a federal judge just rejected, allowing the case to proceed to trial. The wrongful death lawsuit was not settled in the $650 million settlement agreement with the manufacturer in 2014 and is set to go to trial on December 5th in the U.S. District Court for the District of Massachusetts. This is the first lawsuit regarding Pradaxa that is expected to go to trial.
September 16, 2016 – Pradaxa Lawsuits Continue To Be Filed
Despite the 650 million dollar settlement made by Boehringer Ingelheim two years ago to plaintiffs claiming to have suffered serious side effects from using the anticoagulant, Pradaxa, lawsuits are still being filed. Class action lawsuits have recently been filed in Connecticut as well despite the fairly recent availability of an antidote to the drug. The FDA’s approval of Praxbind makes Pradaxa the only new-generation blood thinner on the market today that has any available antidote in the case of an emergency.
August 23, 2016 – Pradaxa Maintains Advantage After Portola Receives FDA Rejection
Boehringer Ingelheim maintains an advantage on the blood thinner front by continuing to have the only new generation anticoagulant on the market with an available antidote. Portola Pharmaceuticals received a rejection this week from the FDA after having sought approval for AndexXa, meant to be an antidote for Eliquis, Xarelto, and Savaysa. The FDA stated the agency had concerns and needed more time to review the company’s recently submitted documents. The FDA granted accelerated approval to Praxbind, Boehringer’s reversal agent for Pradaxa, in October of 2015.
April 26, 2016- FDA Gives Go Ahead For Pradaxa Reversal Agent
The Food and Drug Administration (FDA) recently approved Praxbind to be tested as a Pradaxa-related side effects antidote. Praxbind was approved under a fast-track approval program with the condition that more safety and efficacy data would be provided. The FDA’s approval comes at a time when there had been a five-year period of Pradaxa usage that led to 1,400 cases of Pradaxa-related side effects, with some leading to death because of the drug.
March 22, 2016- Woman Alleges Pradaxa Caused Her Husband’s Death
A Belleville woman filed a lawsuit on February 16 in St Clair County Circuit Court against the makers of the drug Pradaxa, stating product liability. The widow states that her husband had been prescribed and was using the drug when he fell and hit his head in their front yard. He ended up with a cerebral hemorrhage due to the fall, but he died from the internal bleeding. She alleges Pradaxa was responsible for this internal bleeding.
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