Pradaxa

What Is Pradaxa?

Pradaxa (dabigatran) is an anticoagulant medication used to prevent blood clot formation in those who suffer atrial fibrillation (AF) and are at risk for stroke. It is also used in patients who have a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) and as a preventative for those conditions in hip replacement surgery.

Is Pradaxa Available Over the Counter?

Predaxa is not available over the counter. It requires a doctor’s diagnosis and prescription. Pradaxa is given as a daily dose of 75 to 150 mg. Patients with kidney problems may need lower dosages and should be carefully monitored.

Who Manufactures Pradaxa?

Pradaxa is manufactured by Boehringer-Ingelheim, a pharmaceutical company based in Germany. While they are based in Germany, the company is considered one of the largest pharmaceutical companies in the world and has a significant presence in the United States.  Boehringer-Ingelheim was founded in 1885 in Ingelheim am Rhein, Germany. In addition to manufacturing Pradaxa, Boehringer-Ingelheim also develops medicine in several key areas such as:

• Oncology
• Respiratory diseases
• Immunology

When Was Pradaxa Developed and Approved by the FDA?

Pradaxa was approved by the Food and Drug Administration (FDA) in October 2010. By 2012, nearly 4 million prescriptions had been written and the drug had reached over $1 billion in sales. Though many patients may have been helped by Pradaxa, it has also caused severe side effects in thousands of people that resulted in at least 500 deaths due to uncontrolled bleeding. An antidote to Pradaxa was not available until 2015, and many of these events and deaths may have been preventable or treatable had it been available sooner.

How Does Pradaxa Work?

Pradaxa works to prevent blood clot formation by inhibiting the thrombin clotting protein and does not require blood testing. Pradaxa is given as a daily dose of 75 to 150 mg. Patients with kidney problems may need lower dosages and should be carefully monitored.

What Does Pradaxa Treat?

Pradaxa was primarily developed to treat deep vein thrombosis and pulmonary embolisms. However, in some cases, it may also be used as a preventative treatment for those conditions in hip replacement surgery.

What Is Deep Vein Thrombosis (DVT)?

Deep vein thrombosis (DVT) is when a blood clot forms in the veins of the legs, usually due to a lack of movement in the body from surgery or illness. It is a serious condition that can affect blood flow, with a risk of the blood clots breaking loose from the veins.

What Are the Symptoms of Deep Vein Thrombosis?

The symptoms of deep vein thrombosis (DVT) can include:

• Leg swelling
• Leg pain
• Leg cramps
• Leg soreness
• Warm feeling in the leg
• Changes in skin color in the legs

What Is a Pulmonary Embolism (PE)?

A pulmonary embolism (PE), similarly, is also characterized by the formation of a blood clot. The key difference is that PE can disrupt blood flow to the lungs or arteries and can be life-threatening due to its direct influence on breathing. PE usually starts in the legs like DVT and then moves closer to the lungs as it becomes more serious.

What Are the Symptoms of a Pulmonary Embolism?

The symptoms of a pulmonary embolism can include:

• Shortness of breath
• Chest pain
• Fainting
• Fever
• Excessive sweating
• Bloody mucus when coughing
• Lightheadedness
• Dizziness
• Rapid heartbeat
• Irregular heartbeat
• Clammy skin
• Discolored skin

What Are the Side Effects of Pradaxa?

Like other anticoagulants, some Pradaxa patients may experience bruising or bleeding due to minor cuts. Patients who are taking Pradaxa should notify doctors and dentists before surgical procedures to help avoid bleeding complications. The most common side effects of taking Pradaxa are:

• Frequent nosebleed
• Heavier than normal menstrual period
• Pink or brown-tinged urine
• Bruising
• Unusual bleeding of the gums
• Nausea
• Indigestion
• Heartburn
• Stomach pain

Any side effects that occur while using Pradaxa should be reported to a healthcare professional.

What Are the Serious Side Effects of Pradaxa?

Pradaxa use may result in uncontrolled bleeding, which may be fatal. It may also increase the risk of heart attack and has caused severe allergic reactions in some patients. Patients experiencing any of these symptoms should contact a medical professional.

What Is a Heart Attack?

A heart attack occurs when the blood flow to the heart is blocked. Pradaxa has been shown to increase the risk of heart attack. A report, published in the Journal of the American College of Cardiology, assessed several trials with more than 30,000 patients. Results showed that Pradaxa users were 33 percent more likely to suffer heart attacks when compared with warfarin.

What Are the Symptoms of a Heart Attack?

In some cases, heart attacks are very sudden with no warning. In other cases, the symptoms begin to present themselves days or even weeks before the actual heart attack event.

Symptoms of a heart attack may include:

• Chest pain or tightness
• Pain that spreads to other body parts such as the shoulders or arms
• Weakness on one side of the body
• Sudden dizziness
• Cold sweat
• Fatigue
• Heartburn
• Indigestion
• Nausea
• Shortness of breath
• Lightheadedness

Women may present atypical symptoms, which can include:

• Sharp pain in the:
  • Neck
  • Back
  • Arm
• Sudden cardiac arrest

A heart attack is a medical emergency and requires immediate attention.

What Is an Allergic Reaction?

In rare cases, Pradaxa may cause severe allergic reactions. An allergic reaction is when the body produces antibodies to protect you from unknown environmental substances and is an immunoprotective response. Pradaxa patients should seek immediate medical attention if they experience reaction symptoms.

What Are the Symptoms of an Allergic Reaction?

Symptoms of an allergic reaction may include:

•  Rash
• Trouble breathing
• Itching and swelling in the tongue, throat, and face

What Is Uncontrolled Bleeding?

Uncontrolled bleeding is the number one cause of severe injury and death from Pradaxa use. Uncontrolled bleeding is characterized by defective platelet functioning that makes it hard to stop abnormal bleeding levels.

 In 2011, more than 2,300 bleeding events were reported. Because it works by inhibiting the clotting enzyme, thrombin, administration of clotting factors is not effective as an antidote, and before 2015, bleeding caused by Pradaxa was not reversible. Pradaxa manufacturer Boehringer Ingelheim recommended that bleeding episodes be treated with hemodialysis to remove Pradaxa from the bloodstream. This treatment has received criticism as many patients who suffer uncontrolled bleeding were not eligible for hemodialysis treatment. 

What Are the Symptoms of Uncontrolled Bleeding?

Symptoms of uncontrolled bleeding may include:

• Severe pain in the abdomen or stomach
• Vomiting with blood
• Black, tarry stools
• Abdominal swelling
• Excessive tiredness
• Confusion
• Vision changes or slurred speech
• Weakness on one side of the body

What Increases the Risk of Pradaxa Bleeding?

Increased risk factors for Pradaxa bleeding include:

• Being over the age of 75
• Stomach ulcers
• Preexisting kidney problems
• Preexisting or consistent stomach or intestinal bleeding
• Taking other medications that also increase bleeding risk

What Are the Complications of Pradaxa?

In 2011 alone, the FDA received reports of 3,781 adverse events and 542 deaths associated with Pradaxa use. The Institute for Safe Medication Practices reported that Pradaxa was linked to more injury and death reports than any of the 800 drugs that it regularly monitors. Since Pradaxa is a blood thinner, a majority of the adverse reports and deaths were due to excessive bleeding.

Many patients suffered rectal, brain, and gastrointestinal bleeding, and unfortunately, there was no antidote to reverse the fatal bleeding that Pradaxa can cause. An antidote to Pradaxa was not approved until 2015, with the introduction of Praxbind. Though bleeding caused by Pradaxa can now be treated in some cases, many patients were harmed, and some may still be at risk.

What Warnings Has the FDA Issued for Pradaxa?

In June of 2011, the first FDA notice was issued for Pradaxa. A public alert notified healthcare professionals and the public about specific storage requirements, stating that Pradaxa should only be dispensed and stored in the original prescription container or blister pack packaging. The notice stated that improper storage or exposure to moisture could contribute to product breakdown and reduced efficacy. Due to the number of serious adverse event reports, in December 2011, the Food and Drug Administration issued the first of several warning notices regarding the safety of Pradaxa. The first warning only notified healthcare practitioners and the public that numerous bleeding events had occurred and were being evaluated by the agency.

In March 2012, a report published in the Journal of the American College of Cardiology indicated that the evaluation of 30,000 patients showed an increased risk of heart attack when compared to Coumadin. No changes were made to labeling as a result of this study however in December 2012, a new and separate safety warning was issued stating that Pradaxa should not be used in patients with mechanical prosthetic (artificial) heart valves. After a clinical study in Europe was halted, the FDA required that prescribing information include a contraindication against use in patients with artificial heart valves.

Is There a Pradaxa Black Box Warning?

In April of 2013, Pradaxa’s manufacturer Boehringer Ingelheim, announced that they were adding a “black box warning” to the prescribing information. Information regarding an increased risk of clot formation and stroke, when medication is suddenly discontinued, was added to the top of prescribing information, enclosed in a black box. This boxed statement warning was similar to that included on other anticoagulants.

In May 2014, the FDA issued another alert that warned that though elderly Pradaxa patients had a lower risk of stroke, cerebral bleeding, and death than similar Coumadin patients, the risk of major gastrointestinal bleeding was increased. The Medicare study used to provide this data also showed the two drugs had a similar heart attack risk. Again, no changes were required to be made to Pradaxa’s prescribing information. Despite continuing reports of adverse events, Pradaxa was approved in November of 2015, to treat additional conditions including prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with hip replacements.

Was the Antidote for Pradaxa Approved By the FDA?

In October 2015, the FDA approved an antidote to Pradaxa through its fast-track “accelerated approval” pathway. Praxbind (idarucizumab) works to reverse Pradaxa’s anticoagulant effects by binding to the drug and its metabolites. It is given in emergencies when bleeding cannot be controlled due to Pradaxa use. Though older medications like Coumadin already had antidotes, Pradaxa is the first of the “new” anticoagulants that can now be reversed. Full approval for Praxbind was granted in April 2018, after final results from safety studies showed no unexpected results. Most patients show a complete reversal of the blood thinning effect within 4 hours of Praxbind administration after an emergency bleeding event. Healthcare practitioners are advised to resume anticoagulant therapy when appropriate according to the patient’s medical status.

As of 2023, many of the Pradaxa cases have been settled in court. Pharmaceutical manufacturing company Boehringer Ingelheim has paid millions of dollars in settlements to patients who have suffered, however many of the families of the patients who died from Pradaxa use still suffer today due to the negligence and mismarketing of the drug.

What Pradaxa Lawsuits Are There?

Boehringer Ingelheim has faced thousands of lawsuits filed by people who were injured while using Pradaxa. Many Pradaxa lawsuit claims that were filed in federal court were consolidated into multidistrict litigation (MDL). Other Pradaxa lawsuits were consolidated in various state courts including nearly 3,000 cases in Connecticut’s superior court.

Thousands of Pradaxa lawsuits were filed on the basis that Boehringer Ingelheim used deceptive marketing practices to promote the blood-thinning drug. Boehringer marketed the drug as a safer and more effective alternative to warfarin the generic form of the medication. However, evidence suggests that Pradaxa has equal or higher risks of internal bleeding than warfarin. Additionally, Pradaxa was misrepresented as a “one-size-fits-all” treatment. Checkups, laboratory testing, and dosage adjustments were not required in the instructions.

Thousands of patients have filed lawsuits after taking Pradaxa, but as of 2023, the litigation is closed from previous settlements that have been made in the U.S.

What Are the Pradaxa Lawsuit Claims?

Plaintiffs have claimed that Boehringer was negligent by not establishing protocols for treating bleeding episodes. The company recommended dialysis treatment to help remove the drug from the bloodstream. However, medical professionals assert that dialysis treatment is unrealistic, unavailable, or difficult to tolerate by patients who may be experiencing a severe bleeding episode.

It is alleged that the company failed to adequately warn the public of the risks of using Pradaxa. By doing so, Boehringer is held accountable for willfully endangering the public by continuing to market and sell a defective drug. Many believe that Pradaxa was released onto the market prematurely since there is no option for reversing the potentially deadly effects.

What Pradaxa Lawsuit Settlements Are There?

In 2014, the company settled 4,000 lawsuits for $650 million but more patients may have been harmed as an antidote was not approved until 2015. A settlement offer was also reportedly made to approximately 2,935 plaintiffs in Connecticut in November of 2020. In 2021, The U.S. Court of Appeals reversed a $1.25 million award to the family of a deceased woman who experienced severe bleeding after taking Pradaxa as a blood thinner. 

Settlements or awards for medical injury may include compensation for medical costs, lost wages, future medical costs, and pain and suffering. Patients or loved ones of those who experienced serious injury such as hemorrhage or death, should have their case evaluated by legal experts.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.