Pradaxa, also known as dabigatran, is an anticoagulant used to prevent blood clots and strokes. Pradaxa protects against deep venous thrombosis (DVT) and pulmonary embolism (PE). The medication also treats patients with atrial fibrillation not caused by a heart condition.
Manufactured by Boehringer Ingelheim, Pradaxa is advertised for minimal monitoring when compared with the industry-standard drug, Warfarin. Pradaxa has become a frequently prescribed blood clot treatment. By 2012, Pradaxa had been prescribed to more than 3.7 million U.S. patients.
Despite its existing reversal agent, Pradaxa can cause hemorrhaging, hematomas, and uncontrollable bleeding that may be fatal. In 2011, QuarterWatch reported that Pradaxa side effects had been linked to 3,781 serious FDA adverse event reports, including 542 patient deaths.
Studies + Science
Pradaxa is a direct thrombin inhibitor, which blocks blood clots through the body’s clotting agent thrombin. Pradaxa is available in capsule form with doses of 75 mg, 110 mg, and 150 mg.
According to the drug’s labeling, Pradaxa is used for the following indications:
- To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation
- For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days
- To reduce the risk of recurrence of DVT and PE in patients who have been previously treated
- For the prophylaxis of DVT and PE in patients who have undergone hip replacement surgery
Pradaxa Side Effects
Pradaxa is most dangerous for patients over the age of 75. Pradaxa is also dangerous for patients with an artificial heart valve, kidney problems, stomach ulcers, or intestinal bleeding.
Pradaxa has been linked to a number of common side effects, including:
- Minor bleeding
- Minor bruising
- Stomach pain
Pradaxa has also been linked to dangerous side effects, which should prompt an immediate call or visit to a doctor, such as:
- Serious bruising or bleeding
- Coughing up blood
- Pink or brown urine
- Vomit that looks like coffee grounds
- Joint pain or swelling
Pradaxa stops the blood from clotting, making it easier for blood to continue flowing. The medication should not be taken in combination with aspirin or non-steroidal anti-inflammatory drugs like Advil or Aleve. Pradaxa also is risky for patients with genetic spinal defects, a spinal catheter, or patients who underwent spinal surgery or repeated spinal taps.
Compared to Warfarin
Since the 1950s, the blood thinner Warfarin has held the title as the industry-standard anticoagulant. But as the blood-thinning market continues to become more lucrative, newer competitors like Eliquis and Xarelto have entered the playing field.
Warfarin, which requires regular blood monitoring and diet restrictions, comes with a number of side effects. Though its internal bleeding side effect can be reversed with an antidote, many other blood thinners do not have this option.
A study published in the Canadian Medical Association Journal illustrated that the 50 mg dose of Pradaxa comes with higher rates of gastrointestinal bleeding when compared to Warfarin. The study, conducted at St. Michael’s Hospital in Toronto, included 46,000 atrial fibrillation patients above the age of 65. The findings illustrated a 40 percent increase in risk of bleeding or hospitalization.
However, clinical trials show that Pradaxa may be more effective in preventing a stroke than Warfarin, though both come with an available cure. In addition, Pradaxa is more expensive than Warfarin, with a price tag of $3,000 a year.
In The Data: Heart Attacks and Bleeding
In March 2012, the Journal of the American College of Cardiology published a study that found an increased risk of heart attack for Pradaxa users. The study used the U.S. National Institute of Health MEDLINE database information and included 30,470 patients across five trials. The researchers concluded Praxada would lead to a higher chance of heart attack than Warfarin.
Another study, also published in March 2012, came to the same conclusion. The Archives of Internal Medicine published the Cleveland Clinic data that linked Pradaxa to a 33 percent increase of heart attack or heart disease.
In 2011, Pradaxa was linked to more than 500 serious bleeding events. The events caused death or disability. In 2012, eight U.S. patients died from uncontrollable bleeding linked to Pradaxa.
In Japan and Australia, Pradaxa has been the subject of bleeding safety warnings.
- The Japanese Ministry of Health, Labour and Welfare (MHLW) issued a safety advisory after 81 reports of gastrointestinal bleeding, anemia, or renal impairment.
- Australia’s Therapeutic Goods Administration (TGA) found 203 adverse event reports from Pradaxa use, including 47 serious bleeding events.
The Food and Drug Administration (FDA) approved Pradaxa in October 2010. The medication initially existed without a reversal agent, leading to hospitalizations and fatalities.
A 2012 article published in the New York Times reported the drug was responsible for eight deaths at Memorial Hermann-Texas Medical Center. Boehringer Ingelheim has since released an antidote, but fatalities may still occur.
In 2011, the FDA received 800 reports of adverse events involving Pradaxa. QuarterWatch, a monitoring effort from the Institute For Safe Medicine Practices, examined records and found 3,781 Pradaxa side effects. Of the reported adverse events, 542 individuals died.
Pradaxa’s labeling information focuses on four major adverse events, including:
- Increased Risk of Thrombotic Events after Premature Discontinuation
- Risk of Bleeding
- Spinal/Epidural Anesthesia or Puncture
- Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves
In 2012, the FDA released a safety communication explicitly adding a contraindication for the use of Pradaxa in individuals with a mechanical heart valve. The communication also noted that a clinical trial in Europe had been called off studying Pradaxa in individuals with mechanical heart valves.
In April 2013, the FDA added: “People with atrial fibrillation (a type of irregular heartbeat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body” to the list of risks. The drug features a 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).
Boehringer Ingelheim worked hard to get Pradaxa into the hands of consumers, spending more than $464 million in promotions. After many individuals had developed severe bleeding side effects, Pradaxa became the subject of more than 4,000 lawsuits. The lawsuits were filed between 2010 and 2013. In May 2014, the suits were settled with a price tag of $650 million.
2014 Bleeding Update
In September 2014, Pradaxa’s labeling was updated to illustrate a more serious bleeding risk. The FDA released a safety announcement to go along with the medication guide update.
2015 Reversal Agent
In 2015, the FDA updated Pradaxa’s safety information to include the release of antidote to stop the drug’s uncontrollable bleeding. The antidote, known as Idarucizumab, should only be used in two situations:
- For emergency surgery/urgent procedures
- In life-threatening or uncontrolled bleeding
The Next Steps
Patients who experienced hemorrhaging or families who died from the use of Pradaxa have a right to justice. There are a number of available resources for individuals injured by Pradaxa side effects.