More About Pradaxa

Pradaxa (Dabigatran Etexilate)

Pradaxa is an anticoagulant, or blood thinner, most often prescribed to treat and prevent blood clots in patients with atrial fibrillation (without heart valve issues), deep vein thrombosis (DVT), or pulmonary embolism (PE). Pradaxa is also used to reduce the risk of stroke, and to prevent DVT or PE following hip or knee replacement surgery.

Pradaxa is known as a direct thrombin inhibitor, which is a class of anticoagulants. Direct thrombin inhibitors like Pradaxa are so named because they work by inhibiting thrombin, which is a blood-clotting enzyme.

According to its manufacturer, Boehringer Ingelheim, Pradaxa has been growing exponentially in popularity since the U.S. Food and Drug Administration (FDA) approved it in 2010, and has proven to be more effective than the anticoagulant warfarin in reducing certain types of stroke.

However, some studies show Pradaxa carries with it a higher bleeding risk which can turn fatal, and the FDA now warns that there is also an increased risk of blood clots and stroke if you stop taking the medication.

Pradaxa Side Effects and Adverse Reactions

Pradaxa side effects can be serious, and include uncontrolled bleeding which can turn fatal. While internal bleeding is a common Xarelto side effect also, it’s the leading cause of death in Pradaxa patients.

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The FDA has issued a blackbox warning about stopping the use of Pradaxa, which can increase the risk of bleeding and stroke. Pradaxa can also cause a very serious blood clot in your spinal cord, which can lead to paralysis, if you have a spinal tap or an epidural.

If you’re currently taking Pradaxa, consult your physician before discontinuing use.

Most Common Side Effects of Pradaxa

  • Stomach pain
  • Nausea and upset stomach
  • Heartburn
  • Unusual bruising or bleeding
  • Brown or pink urine
  • Bloody or black, tarry stools
  • Coughing up or vomiting blood or material that looks like coffee grounds
  • Gum bleeding
  • Frequent nosebleeds
  • Heavy menstrual bleeding
  • Headache
  • Joint pain or swelling
  • Difficulty breathing or swallowing
  • Weakness, dizziness or feeling faint
  • Bleeding from a cut that lasts longer than normal
  • Chest pain or tightness

Allergic Reactions Caused by Pradaxa

Some Pradaxa users may experience symptoms of an allergic reaction. Contact your doctor if you experience:

  • Hives, rashes, and itching
  • Chest pain or tightness
  • Trouble breathing
  • Dizziness or feeling faint
  • Swelling of your face or tongue

Severe Side Effects of Pradaxa

In addition to the more common mild side effects and adverse reactions listed above, Pradaxa can cause a number of severe side effects. These can lead to severe pain and suffering, long-term health problems, and even death.

Pradaxa and Bleeding

When taking the blood thinner Pradaxa, patients may experience more severe symptoms, like coughing up or vomiting blood or blood-like material, bloody or black stools, and bruising and bleeding that takes longer to go away or stop. These symptoms may be a clue that other damaging bleeding episodes could occur within the body.

Pradaxa, like other anticoagulant therapies, runs an increased risk of bleeding in the brain, major gastrointestinal bleeding, myocardial infarction (heart attack), which all can lead to death. In a study performed by the FDA, Pradaxa was found to have an increased risk of major gastrointestinal bleeding over other anticoagulants, like warfarin.
Pradaxa safety information

Discontinuing Use of Pradaxa

Despite the potential side effects of Pradaxa, the FDA still considers the benefits of the drug to outweigh the potential problems for many patients. However, if a patient wants to discontinue the use of Pradaxa, they should do so with the supervision of their healthcare provider. Discontinuing the use of Pradaxa or other blood thinning medications can greatly increase the risk of stroke or other blood clotting complication.

Pradaxa’s Prescribing Information and Medication Guide provides information and warnings for patients about discontinuing the medication without the guidance of a healthcare professional and without understanding the increased risk for strokes. However, in April 2013, Boehringer Ingelheim announced that it was adding an FDA black box warning, the most serious warning the FDA uses on prescribing information, to alert patients to the risk of stroke when a patient discontinues the use of Pradaxa.

Pradaxa Black Box Warning

WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA
See full prescribing information for complete boxed warning

(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy (2.4, 2.5, 2.6, 5.1).

(B) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis (5.3). Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated (5.3).

Sometimes Pradaxa will need to be stopped before any medical or dental procedure or surgery. If you need to stop taking Pradaxa for another medical event, speak to the doctor who prescribed Pradaxa to you and ask when you should stop taking it leading up to your procedure and when you can start taking it again.

Pradaxa and Blood Clots

Anticoagulants like Pradaxa are prescribed to help patients reduce their incidence of blood clots. However, using Pradaxa can also increase the risk of blood clots in certain situations. For example, patients who receive an epidural or spinal tap may develop a blood clot in their spinal cord that can lead to paralysis.

Patients are more likely to develop a spinal blood clot if:

  • an epidural catheter is placed in your spine used to give certain medicines
  • you are currently taking NSAIDs or other blood thinning medicines
  • you have a history of spinal issues and surgeries
  • you have a history of repeated or difficult spinal punctures

If you receive a spinal anesthetic or spinal puncture while you are taking Pradaxa, your doctor should monitor you closely for signs and symptoms of a spinal blood clot. Additionally, tell your doctor immediately if you experience any of the symptoms below:

  • Back pain
  • Tingling and numbness
  • Muscle weakness, especially in your legs and feet
  • Incontinence

Pradaxa and Heart Attacks

While gastrointestinal bleeding is the most frequent adverse event reported for Pradaxa use, other events including stroke, acute kidney failure, liver failure, and heart attacks have been reported too.

Two separate studies published concurrently showed an increased risk of heart attacks for Pradaxa users over user of other blood thinning agents like warfarin.

Seek medical help immediately if you are taking Pradaxa and experience the following severe symptoms of heart disease:

  • Chest pain
  • Shortness of breath
  • Dizziness and loss of consciousness

Pradaxa Deaths and Injuries

A study found that when compared to warfarin, Pradaxa poses an increased risk of severe gastrointestinal bleeding. Pradaxa has also been cited as the cause of rectal and brain bleeding, all leading to more than 4,000 lawsuits.

Approved by the FDA in 2010, Pradaxa didn’t have an antidote to stop its blood-thinning effects until 2015. Doris Daumler of Wisconsin suffered hemorrhaging while on the drug, which ultimately led to her death. Her brother, Walter Daumler, is among those who have filed a lawsuit against Pradaxa’s manufacturer.

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According to a New York Times report, 542 patients deaths linked to Pradaxa were reported to the FDA in 2011, and was cited on more report of injury or death than any drug monitored by the Institute for Safe Medication Practices.

In 2012, The FDA warned that Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves (mechanical prosthetic heart valves) after it was found that Pradaxa patients with these valves were at an increased risk of stroke, heart attack, and blood clots than patients using warfarin.

Prior to the contraindication, Pradaxa was cited as the cause of hemorrhaging and uncontrollable bleeding that led to more than 500 deaths.

Investigation of Pradaxa Side Effects

Pradaxa was approved by the FDA and released to the public in 2010 as an alternative option to warfarin. However, it became clear in the first year after numerous reports of severe bleeding events, that the approved and stated side effects of the medication needed further investigation from the FDA.

How Safe Is Pradaxa?Timeline of Pradaxa Side Effect Studies
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October 2010
The U.S. Food and Drug Administration (FDA) approves Pradaxa as an anticoagulant for prevention of blood clots and stroke in patients who experience non-valvular atrial fibrillation (abnormal heart rhythm).
February 2011
After reports of a chronic kidney patient who experienced severe gastrointestinal bleeding while using Pradaxa, the Institute for Safe Medication Practices (ISMP), a U.S. non-profit organization, releases a safety alert advising physicians to appropriately adjust prescriptions of Pradaxa in patients who have a history of kidney or renal problems.
December 2011
The FDA releases a statement stating they are conducting a safety review of post-marketing reports of serious bleeding events in patients using Pradaxa.
January 2012
The ISMP releases report of over 500 cases of fatal and other severe bleeding events linked to Pradaxa use in the elderly.
March 2012
The Journal of Neurosurgery publishes a report that discusses the case of an 83-year old patient using Pradaxa who died of a cerebral hemorrhage after a fall. The reports was published to highlight the risk of severe bleeding in Pradaxa patients and urge the development of an antidote.
May 2012
A presentation at the Thrombosis & Hemostasis Summit of North America in 2012 revealed results from a real-world study comparing Pradaxa and warfarin and claimed that warfarin was safer than Pradaxa. The results showed that complications arose more often when a patient discontinued Pradaxa compared to patients who discontinued warfarin. Additionally, complications caused by Pradaxa appeared very early in treatment, after less than four months on average.
June 2012
The ISMP QuarterWatch report states that Pradaxa was the leading drug responsible for fatalities than with any other drug in 2011. According to the report Pradaxa use lead to a total of 3,781 reports with 542 patient deaths. The other reports consisted of hemorrhaging, acute renal failure, and stroke.
September 2012
A study published in The Archives of Internal Medicine suggests that oral anticoagulants, like Pradaxa and Xarelto, may pose risks that outweigh any benefits when used in patients who experienced acute coronary syndrome (ACS) and are receiving antiplatelet therapy.
September 2012
A study published in The Circulation: Cardiovascular Quality and Outcomes journal suggests that Pradaxa did not increase the effects on the treatment of atrial fibrillation. The study suggests that Pradaxa’s off-label uses are on the rise.
September 2012
A report is published in The Journal of the American Medical Association (JAMA) highlighting the dangers of expedited FDA approval of medication without fully understanding the side effects and safety of the drug. The report used Pradaxa as one of the three medications used as examples.
October 2012
Boehringer Ingelheim halts part of the RE-ALIGN clinical trial, where patients were randomized to warfarin or Pradaxa after a mechanical valve surgery. The patients using Pradaxa in this trial had an increased risk for blood clots. The FDA released a safety alert soon after to healthcare providers and patients setting the standard that Pradaxa not be used in patients with mechanical prosthetic heart valves.
May 2014
The FDA completed a study in Medicare patients using either Pradaxa or warfarin to understand the risks for stroke, bleeding in the brain, gastrointestinal bleeding, heart attack and death. The study reported that Pradaxa has lower risks for stroke and death, but a higher risk of gastrointestinal bleeding compared to warfarin.

Pradaxa Antidote & Reversal Agent

When Pradaxa was first sold in the U.S., there was no antidote or reversal agent developed to reverse the blood thinning properties during a bleeding event. For the first five years of it’s use, Pradaxa quickly outpaced another warfarin in reported adverse events, causing thousands of patients to suffer sometimes fatal uncontrollable bleeding. This had led to thousands of patients and families to file lawsuits against its manufacturer, Boehringer Ingelheim, stating that patients weren’t properly warned about the severe side effects of the drug.

In October 2015, the FDA granted accelerated approval to an antidote called Praxbind (idarucizumab), which can reverse Pradaxa’s blood thinning effects in a patient experiencing uncontrollable bleeding. Currently, Pradaxa is the only blood thinning medication with an FDA approved antidote.

Because the Pradaxa antidote Praxbind received accelerated approval, many healthcare providers are wary of the safety of the antidote and advise patients to consider all of the benefits and drawbacks when considering relatively new blood thinners like Pradaxa and Xarelto.

Pradaxa Drug Interactions

As with any new drug or supplement, it’s important to be aware of any potential interactions it may have with your current prescription or OTC medications. Blood thinners like Pradaxa should not be taken with other medications or supplements that have blood thinning properties, including aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).

More than 379 drugs may interact with Pradaxa. Those that are most commonly checked warned against include the following. This list is not all-inclusive, so be sure tell your doctor about any and all medications and supplements you may be taking.

Drugs That Interact with Pradaxa
  • amiodarone
  • amlodipine
  • aspirin
  • carvedilol
  • Crestor (rosuvastatin)
  • digoxin
  • gabapentin
  • Lasix (furosemide)
  • levothyroxine
  • Lipitor (atorvastatin)
  • lisinopril
  • metformin
  • Metoprolol Succinate ER (metoprolol)
  • omeprazole
  • potassium chloride
  • simvastatin
  • Vitamin D3 (cholecalciferol)

Pradaxa Uses & Medical Information

Pradaxa was approved by the FDA in 2010 for stroke prevention in atrial fibrillation in patients without other heart valve issues.

Pradaxa Drug Details

BRAND NAME
Pradaxa

GENERIC NAME
dabigatran etexilate

TREATS/PREVENTS
Blood clots, deep vein thrombosis (DVT), traveling blood clots (systemic embolism), pulmonary embolism (PE), stroke

MANUFACTURER
Boehringer Ingelheim Pharmaceuticals, Inc.

COMMON DOSAGES
75mg, 150mg

Thrombin is a protein found in the blood responsible for clotting, and Pradaxa, an oral anticoagulant, works by blocking its action, keeping the blood flowing smoothly. Other blood thinners known as antiplatelets work by preventing the blood cells known as platelets from clumping together.

Other Approved Pradaxa Uses

Since Pradaxa’s first 2010 approval, the FDA has approved the drug for two additional uses. Then in 2014, Pradaxa was approved for deep vein thrombosis (DVT) and pulmonary embolism (PE), and then for prophylaxis of DVT and PE following hip replacement surgery in 2015.

Clinical Trials: Pradaxa vs Warfarin

RE-COVER I and RE-LY are the earliest Pradaxa clinical trials which ran in 2009. Respectively, their purpose was to compare the safety of Pradaxa to warfarin in treating patients with DVT and PE, and how well Pradaxa works relative to warfarin at mitigating the risk of stroke in patients with atrial fibrillation not caused by a heart valve problem. Traditionally, blood clots have been prevented by taking warfarin.

These trials are said to have shown that Pradaxa is as effective as warfarin for preventing blood clots that lead to stroke, while potentially causing fewer side effects and being easier to use. The makers of Pradaxa claim that it doesn’t require frequent blood tests (warfarin does) and isn’t affected by food (warfarin is).

These head-to-head trials catalyzed Pradaxa’s 2010 FDA approval, but studies since then have shown contradictory results. For example, a University of Pittsburgh survey of 9,400 men and women with atrial fibrillation covered by Medicare showed that among those taking Pradaxa, 9% suffered a major bleed compared to 6% taking warfarin.

Clinical trials are still ongoing and include RE-SPECT ESUS, which is currently recruiting participants with recent embolic stroke of unknown source (ESUS) to study Pradaxa’s ability to prevent a second episode.

Pradaxa Lawsuits

Because Pradaxa was sold for five years without an approved antidote, thousands of patients have experienced severe, uncontrollable bleeding and hemorrhaging. This led to more than 4,000 Pradaxa lawsuits against Boehringer Ingelheim, who settled in May 2014 for $650 million. Other blood thinners have also been in the news lately for similar reasons. Several of the 18,000 Xarelto lawsuit verdicts have been making headlines during the ongoing bellwether trials. So far, plaintiffs have failed to win a case against the manufacturers of that drug.

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