FAQs About Pradaxa

Blood thinners are a necessary part of life for people at risk for blood clots. For decades, patients taking traditional blood thinners had to eat restricted diets and check in with their doctor for routine blood monitoring. But when a new kind of blood thinner hit the market, patients rejoiced in their newfound freedom. No more restrictive diets and no more blood monitoring. But soon after one of the most-popular novel blood thinners hit the market, patients, doctors and federal regulators found out that that newfound freedom came at a price. Sometimes, that price was a patient’s life.

What is Pradaxa?

Pradaxa (dabigatran) is a prescription blood thinner used to prevent blood clots in certain patients. Pradaxa is part of a new class of drugs approved by the Food and Drug Administration (FDA) called novel oral anticoagulants, or NOACs.

NOACs have a rapid onset of action, working quickly within the body to reduce clot risks, and are not as affected by a person’s diet like the traditional anticoagulant warfarin. NOACs also have relatively short half-lives, meaning they leave the body in a relatively short amount of time. For these reasons, NOACs are becoming a popular choice for patients at risk for blood clots.

What is Pradaxa used to treat?

Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, or afib, a condition in which the heart beats irregularly and increases a person’s chance of developing blood clots. Patients with afib are at a five-fold increased risk of stroke, and it is estimated that 15 to 20 percent of all strokes are attributable to afib, according to a Duke University study published in 2012.

Pradaxa is also used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in certain patients, as well as preventing DVT and PE in patients who have undergone hip replacement surgery. DVT is a blood clot that forms in a deep vein, usually in the legs. PE occurs when a blood clot gets lodged in an artery in the lung. Both DVT and PE are risk factors of surgeries and medical conditions that affect how the blood clots, including afib.

How does Pradaxa work?

Pradaxa belongs to a class of drugs called direct thrombin inhibitors (DTIs). DTIs work by blocking the action of thrombin in the coagulation process. Thrombin is a key enzyme in clot formation; by binding to and inhibiting thrombin, DTIs keep clots from forming.

There are three types of DTIs, including bivalent, univalent and allosteric inhibitors. Pradaxa is a univalent DTI, meaning it binds only to the active site of the thrombin enzyme.

Who makes Pradaxa?

Pradaxa is manufactured by the German pharmaceutical company Boehringer-Ingelheim. Boehringer-Ingelheim is one of the world’s 20 leading pharmaceutical companies, bringing in roughly €14.8 billion ($16.7 billion) in global net sales in 2015.

When was Pradaxa approved by the FDA?

Boehringer-Ingelheim received FDA approval for its new anticoagulant Pradaxa on Oct. 19, 2010. Since the drug’s approval nearly six years ago, Pradaxa has brought in billions of dollars for the German pharmaceutical company. In 2014, it was one of the company’s four top-performing products, bringing in roughly €1.3 billion ($1.5 billion) in global net sales.

What are some of the side effects of Pradaxa?

Like all drugs, Pradaxa carries the risk of certain side effects which can range from mild to severe. The most common side effects according to the drug’s package insert include:

  • Indigestion
  • Heartburn
  • Stomach pain

Pradaxa can also cause severe, potentially life-threatening side effects in some people. Severe side effects include:

  • Allergic reactions
    • hives, rash and itching
    • chest pain or chest tightness
    • swelling of the face or tongue
    • trouble breathing or wheezing
    • feeling dizzy or faint
  • Unexpected or uncontrollable bleeding
    • Unusual bleeding from the gums
    • Nose bleeds that happen often
    • Menstrual bleeding that is heavier than normal
    • Gastrointestinal or other internal bleeding

Studies have also found a small, but statistically significant increased risk of myocardial infarctions (heart attacks) in patients taking Pradaxa compared to those taking warfarin.

What is the risk of serious bleeding with Pradaxa?

Pradaxa is a blood-thinning medication that helps prevent life-threatening blood clots from forming and traveling to the heart, brain or lungs.

Pradaxa’s blood-thinning qualities, however, can prevent the body from forming necessary blood clots, such as those that stop cuts from bleeding. For this reason, people taking Pradaxa may find that they bruise more easily or that bleeding takes longer to stop. Pradaxa can also cause episodes of serious, uncontrollable bleeding in some patients.

Unlike traditional anticoagulants, like warfarin, there was no antidote or reversal agent for Pradaxa for the first five years it was on the market. This meant that doctors could not stop a patient’s uncontrollable bleeding after it started. Some patients bled out and died as a result of taking Pradaxa.

Does Pradaxa increase my risk for gastrointestinal bleeding?

Several studies have shown that Pradaxa puts patients at an increased risk for gastrointestinal (GI) bleeding than the traditional anticoagulant warfarin, including the initial trial that helped get Pradaxa approved by the FDA.

One study published last year in JAMA Internal Medicine found users of Pradaxa were more than 1.5-times more likely to suffer from gastrointestinal bleeding than users or warfarin. The study also found patients taking Pradaxa were 1.3-times more likely to suffer from any sort of bleeding episode compared to patients taking warfarin.

“[Pradaxa] was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed. The risk of major bleeding among [Pradaxa] users was especially high for African Americans and patients with chronic kidney disease,” the study authors indicated.

Who is most at-risk for gastrointestinal bleeding?

Certain patients may be at a higher risk for gastrointestinal or other bleeding episodes while taking Pradaxa.  According to the drug’s medication guide, patients may have an increased risk for bleeding if they:

  • Are over 75 years old
  • Have kidney problems
  • Have stomach or intestine bleeding that is recent or keeps coming back
  • Have a stomach ulcer
  • Take other medicines that increase risk for bleeding
    • Aspirin or aspirin containing products
    • Long-term use of NSAIDs (non-steroidal anti-inflammatory drugs)
    • Warfarin (Coumadin, Jantoven)
    • A medicine that contains heparin
    • Plavix (clopidogrel bisulfate)
    • Effient (prasugrel)
  • Have certain kidney problems and also take the medicines Multaq (dronedarone) or Nizoral (ketoconazole)

What are the signs and symptoms of serious bleeding?

Pradaxa puts patients at an increased risk for serious bleeding. Sometimes, bleeding can occur inside the body and is not always apparent when it occurs. Patients taking Pradaxa should be aware and call their doctor or get medical help right away if they notice any of the following signs or symptoms:

  • Unexpected bleeding or bleeding that lasts a long time
  • Bleeding that is severe or cannot be controlled
  • Pink or brown urine
  • Red or black stools (look like tar)
  • Bruises that happen without a known cause or get larger
  • Cough up blood or blood clots
  • Vomit blood or materials that look like coffee grounds
  • Unexpected pain, swelling or joint pain
  • Headaches, feeling dizzy or weak

Is there an antidote to Pradaxa?

The FDA recently approved an antidote to Pradaxa, making it the first novel oral anticoagulant with an approved reversal agent.

The antidote, called Praxbind, was approved on October 16, 2015 nearly five years to the day after Pradaxa was approved by the FDA.

Praxbind (idarucizumab) is used during emergency situations when it is necessary to reverse the blood-thinning effects of Pradaxa. Praxbind works by binding to the drug compound to neutralize its effect. Praxbind is given intravenously.

Has the FDA issued any warnings about Pradaxa?

The FDA has issued several warnings to physicians and consumers since Pradaxa was approved six years ago.

Just over one year after Pradaxa was put on the market, the FDA issued its first communication regarding the risk of gastrointestinal bleeding. The agency said it was evaluating numerous post-marketing reports of serious, even fatal, bleeding events in patients. By that time, more than 371,000 patients had filled a prescription for Pradaxa in the U.S.

About a year after the first communication, the agency issued an update. It said it did not find an increased risk of bleeding events for patients taking Pradaxa compared to patients taking warfarin but it would continue to evaluate the data.

Then, in 2014, the FDA issued a second update regarding the risk for gastrointestinal bleeding and Pradaxa. The agency, which conducted a study of more than 134,000 Medicare patients, said there was an increased risk of gastrointestinal bleeding in patients taking Pradaxa compared to those taking warfarin. Nearly one million patients had filled prescriptions for Pradaxa by the time the agency issued its update.

How do I take Pradaxa?

Pradaxa is a taken by mouth twice a day approximately every 12 hours. It is available in 150 mg, 110 mg and 75 mg dose capsules, which can be taken with or without food but with a full glass of water.

Patients should stop taking Pradaxa one to two days before any planned surgery because of the increased risk for bleeding. Patients undergoing major surgery may need to stop taking it more than two days beforehand.

The dose of Pradaxa may be lowered for people with severe renal impairment, but unlike warfarin, patients taking Pradaxa do not need to go in for routine blood monitoring.

How much does Pradaxa cost?

Like all novel oral anticoagulants, Pradaxa is much more expensive than traditional anticoagulants like warfarin. Part of the reason is because there are no generic versions of the drug available.

According to Drugs.com, the price per pill of Pradaxa is about $6.28 for all dosages.

The makers of Pradaxa offer discounts with its patient assistance program, but not all patients will qualify. Some pharmacies also offer discount cards and other coupons to help patients with the price of their prescription.

Are there generic versions of Pradaxa?

There are currently no generic versions of Pradaxa available because the makers of Pradaxa still own exclusive marketing rights over the product. Boehringer-Ingelheim is set to lose its exclusive rights over Pradaxa in 2018.

Are there lawsuits against the makers of Pradaxa?

There is pending litigation against the makers of Pradaxa in U.S. federal court. The lawsuits allege the company failed to adequately warn consumers about the potential risks of the drug.

Thousands of lawsuits were consolidated in a multi-district litigation (MDL) in the U.S. District Court for the Southern District of Illinois. Currently, four are pending in the MDL overseen by U.S. District Judge David R. Herndon.

In 2014, Boehringer-Ingelheim announced it would settle roughly 4,000 cases pending in federal court for $650 million. The company did not admit wrongdoing even though it agreed to a settlement.

I suffered from uncontrollable bleeding after taking Pradaxa. Can I file a claim?

Even though the makers of Pradaxa agreed to settle thousands of cases in 2014, it is not too late to file a claim if you were harmed after taking Pradaxa.

The lawyers at Hood National Law Group are experienced in handling these types of cases and can help you understand your legal options.

If you or a loved one suffered from uncontrollable bleeding after taking Pradaxa, you need to act now. Call the Hood National Law Group today at 1-800-214-1010 for a free case evaluation or fill out the form on the right-hand side of your screen.