Pradaxa side effects have been linked to an increased risk of internal bleeding and stroke. We are working with some of the leading Pradaxa lawyers in the United States. A claim and/or Pradaxa lawsuit can be filed on your behalf and there is no fee until you receive an award or a Pradaxa settlement. Contact us for a free consultation online or toll free at 1-800-992-6878.
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The blood-thinning drug PRADAXA has been linked to fatal internal bleeding and heart attacks. The FDA approved Pradaxa in October 2010 and it is manufactured by Boehringer Ingelheim Pharmaceuticals. Pradaxa is used to treat atrial fibrillation, an irregular heartbeat that can increase a patient’s risk of stroke. A study published in the Archives of Internal Medicine in 2012 found that Pradaxa was “significantly associated with a higher risk” of heart attacks and acute coronary syndrome compared to the alternative wafarin.
The FDA received reports of over 500 cases of hemorrhaging in the first quarter of 2011 alone. The median age of patients with serious bleeding issues is 80 years old, with at least a quarter of the patients over the age of 84. In the fall of 2011, there were reports that as many as 260 deaths worldwide have been linked to Pradaxa. Many of these deaths may have been a result of internal bleeding.
SYMPTOMS OF INTERNAL BLEEDING INCLUDE:
- Unusual bleeding or bruising
- Coughing up or vomiting blood
- Headaches and dizziness
- Weakness or swelling of arms and legs
- Pink or brown colored urine
- Red or black tarry stools
The manufacturers of Pradaxa marketed the drug to be a more convenient alternative to the standard blood thinning medication wafarin, which has been used for decades. However, bleeding caused by the drug wafarin can be cancelled with doses of vitamin K, whereas bleeding from Pradaxa has no antidote and can have fatal consequences. In November of 2011, the European Medicines Agency recommended that physicians assess patients’ renal function before prescribing Pradaxa, and that they exercise caution if prescribing it to elderly patients or patients with renal impairment.
Pradaxa Side Effects
Manufactured by Boehringer Ingelheim, Pradaxa was approved by the FDA in October 2010 and released on the market shortly after. Though Pradaxa was heavily marketed to be superior and more convenient than the traditional medication, Warfarin, the extreme number of severe side effects resulting from Pradaxa use has many people questioning whether Pradaxa should be recalled.
Though many side effects, such as heart attacks, strokes, and acute renal failure, have been linked to Pradaxa, the most prevalent Pradaxa side effect is internal bleeding/hemorrhaging. Though Pradaxa is proclaimed to be superior to Warfarin, Warfarin has far fewer reports of adverse effects and has an antidote to stop the bleeding. While Warfarin-related bleeding may be stopped with the use of Vitamin K, Pradaxa bleeding has no antidote. This may explain why the FDA received more adverse event reports from Pradaxa use than any other drug in 2011. A large percentage of these reports, including over 540 deaths, were related to Pradaxa bleeding.
Signs/Symptoms of Pradaxa bleeding:
- Frequent nosebleeds
- Pink or brown urine
- Vomiting that resembles blood or looks like coffee grounds
- Red or black tarry stools
- Coughing up blood
- Bleeding from the gums
- Unusual bruising or bleeding / hemorrhaging
- Joint pain or swelling
- Swelling of the arms, hands, feet, ankles or lower legs.
With all the severe Pradaxa side effects being reported and the still-growing number of Pradaxa deaths, the FDA has expressed its concern with the drug and stated that it will be looking into/investigating the situation.
Pradaxa Medical Studies
Recent medical studies have linked the use of Pradaxa to a substantially increased risk for internal bleeding, acute coronary syndrome (ACS), and heart attacks. These studies have included tens of thousands of patients and have been in prestigious publications, such as the archives of internal medicine. One conclusion stemming from these Pradaxa studies is that patients taking Pradaxa are at a 33% higher risk for heart attacks and acute coronary syndrome (ACS) than patients taking another blood-thinner or a placebo.
Another Pradaxa study, which tested the number of severe complications in patients taking Pradaxa vs those taking the alternative Warfarin, found that the number of adverse reports associated with Pradaxa was 12 times higher than with Warfarin. These adverse reports included one deep venous thrombosis, one atrial thrombus, one transient ischemic attack, one skin rash, four patients with GI complications, four internal bleeding episodes, and one death.
All of the controversy surrounding these Pradaxa side effects has caught the attention of the FDA. The FDA expressed its concern with all the reports of severe complications resulting from Pradaxa use, and has stated that it is looking into and investigating the situation. Outside of the FDA, people everywhere, including prominent medical malpractice attorney Robert K. Jenner of Baltimore’s Janet, Jenner & Suggs, have demanded that Pradaxa be recalled immediately.
If Pradaxa has injured you or a loved one, you may want to speak with an experienced Pradaxa lawyer immediately. A Pradaxa attorney can help you make important personal decisions regarding your potential claim.
The FDA approved the anticoagulant drug Pradaxa in October 2010. Though it has only been on the market for less than two years, Pradaxa is already number one on the FDA’s list of total adverse reports. This list, which contains almost 3,800 adverse reports, includes over 540 deaths, nearly 2,400 hemorrhages, 291 reports of acute renal failure, and over 640 strokes.
With all of these serious Pradaxa side effects, Boehringer Ingelheim (the manufacturer of Pradaxa) now faces many lawsuits on behalf of those who have been injured by the drug. The most recent Pradaxa lawsuit, filed in Illinois, relates to cases of excessive gastrointestinal bleeding that led to being admitted to the hospital and required a blood transfusion. Like the other Pradaxa lawsuits, the claims in this case against Boehringer allege that Pradaxa is a dangerously defective medication, and that Boehringer failed to warn of the risks associated with taking the drug.
If you feel as though Pradaxa has injured you, please contact an experienced defective drug attorney right away.
In order to prove that you have an injury that should be compensated for by the pharmaceutical company, you must prove that the drug either did not have adequate warnings, was defective in the condition it was put on the market in, or that this form of the drug that you took was in some way defective. The next thing that you have to prove is that the drug caused the side effect or disease that you were diagnosed with.
To prove this, people need many different experts and medical opinions. You will need the opinion of your physician and medical experts. There are experts that are brought in to prove that the drug is in fact defective. These lawsuits are very time-consuming and detailed but if you have one, you deserve to be compensated for your injuries. Hiring an experienced Pradaxa attorney can help you make important personal decisions regarding moving forward with your claim.
In addition to the severe gastrointestinal bleeding suffered by many of the plaintiffs in the current Pradaxa lawsuits, these serious side effects have also been linked to the use of Pradaxa:
- Acute Renal Failure
- Heart Attacks
If you have any of the above symptoms and believe that you suffered these because of your use of Pradaxa, you may have a valid lawsuit against the manufacturer.
About Pradaxa Manufacturer
The dangerous drug Pradaxa was manufactured by the German pharmaceutical company, Boehringer Ingelheim, whose parent company is C.H. Boehringer Sohn A.G. & Ko. KG. Albert Boehringer in Germany founded Boehringer Ingelheim in 1985. It is now one of the world’s 20 leading pharmaceutical companies, with 145 affiliates globally and 42,000 employees. Beginning in June 2012, the launch of Pradaxa has been the most successful in the drug company’s industry before the dangers were revealed.
Pradaxa is an anticoagulant drug intended to reduce the risk of stroke and embolism caused by Atrial fibrillation (Afib). Afib is a condition that causes irregular heartbeats, increasing the chance of blood clots in the body and the chance of strokes. However, it has been linked to fatal side effects such as causing uncontrolled excessive bleeding in patients. Moreover, what makes Pradaxa more dangerous is that, unlike traditional blood thinning medications, there is no way to reverse the drug’s process. One doctor mentions that he expects a 5% increased lifetime risk of heart attach if the patient is on the drug for 10 years. Studies have found that patient’s taking Pradaxa have a 33% higher risk of heart attacks or severe symptoms of heart disease than do patients taking warfarin, another anti-clotting drug.
On August 8, 2012, a Pradaxa Multidistrict Litigation (MDL) was established in the U.S. District Court of the Southern District of Illinois to consolidate all the lawsuits claiming injuries from Pradaxa. By the end of August, there were nearly 80 lawsuits in the MDL. One of the plaintiffs in the lawsuit suffered complications of bleeding from the drug and was hospitalized for four days. Even worse, in the first 5 months that Pradaxa was prescribed, there have been 500 cases of life-threatening bleeding and 117 deaths as a result of taking this drug. However, despite the growing litigation about Pradaxa, there is still no sign of recall.
Pradaxa Whistleblower Lawsuits
Recently, a federal judge’s ruling in the on-going multi-district litigation against the Pradaxa manufacturer, Boerhinger Ingelheim, will allow the plaintiffs a chance for discovery pf information relating to Boerhinger Ingelheim whistle-blower lawsuits. Despite an effect by the Pradaxa and Boerhinger attorneys to put a protective order on the information, the judge ruled that information regarding the $95 million settlement by Boerhinger to end the whistleblower claims about Micardis, Atrovent, Combivent and Aggrenox is relevant and that the plaintiffs should be given an opportunity to discover it.
Because the previous whistleblower lawsuits, which Boerhinger invested $95 million in preventing from going to trial, deal with the manufacturer’s conduct of improperly marketing and promoting the other four drugs, the Judge held that the plaintiffs (who suffered severe Pradaxa side effects) are entitled to inquire and discover information about past allegations of improper conduct – especially claims by former Boerhinger Ingelheim insiders. Additionally, because many of the claims against Pradaxa involved in this multi-district litigation also claim that the Pradaxa manufacturer improperly marketed and failed to disclose the severe side effects, the establishment of consistent improper conduct by Boerhinger is certainly relevant to the Pradaxa lawsuits.
The Pradaxa lawsuits claim that Boerhinger Ingelheim improperly marketed and failed to disclose relevant information regarding the severe Pradaxa side effects which include internal bleeding, hemorrhaging, heart attacks, strokes, and acute renal failure.
PLEASE SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING USE OF PRADAXA OR ANY OTHER PRESCRIPTION MEDICATION.
Contact the Law Offices of d'Oliveira & Associates, P.C.
If you believe that you or one of your loved ones have been injured by PRADAXA, you may want to speak with a personal injury attorney regarding a potential claim. An injury lawyer familiar with new developments in the investigation of PRADAXA may be able to help you make important personal and legal decisions. d’Oliveira & Associates, P.C. is working with some of the leading lawyers in the country who are handling these cases.
Please contact the law offices of d'Oliveira & Associates, P.C. at 1-800-992-6878 or fill out a contact form for a free legal consultation.