What Is Pradaxa?
Pradaxa (dabigatran) is an anticoagulant medication. It is 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.
Pradaxa was developed to be an alternative to the blood thinner, warfarin, which requires frequent blood clotting tests to ensure proper dosing and is known to have serious risks. While warfarin and Pradaxa treat the same condition, they work differently.
Pradaxa works to prevent blood clot formation by inhibiting the clotting protein, thrombin 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.
Pradaxa was approved by the Food and Drug Administration (FDA) in October of 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 and has resulted in at least 500 deaths due to uncontrolled bleeding.
Pradaxa Side Effects
Like all medications, Pradaxa may cause side effects. In most cases, the side effects of Pradaxa are not sever but others can be serious or life-threatening.
Common 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 prior to surgical procedures to help avoid bleeding complications.
Symptoms of bleeding may include:
- Frequent nosebleed
- Heavier than normal menstrual period
- Pink or brown-tinged urine
- Unusual bleeding of the gums
Other common side effects may include:
- Stomach pain
Any side effects that occur while using Pradaxa should be reported to a healthcare professional.
Severe Pradaxa Side Effects
Pradaxa use may result in uncontrolled bleeding, which may be fatal. It may also increase the risk for heart attack and has caused severe allergic reactions in some patients.
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 attack when compared with warfarin.
In rare cases, Pradaxa may cause severe allergic reactions. Pradaxa patients should seek immediate medical attention if they experience reaction symptoms such as severe dizziness, rash, trouble breathing, and itching and swelling that occurs in the tongue, throat, and face.
Uncontrolled bleeding is the number one cause of severe injury and death from Pradaxa use. 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 prior to 2015, bleeding caused by Pradaxa was not reversible.
Pradaxa manufacturer Boehringer Ingleheim recommendede that bleeding episodes are 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. Many patients were simply monitored as Pradaxa was cleared from the body.
In 2015, a binding agent known as Praxbind was approved as an antidote. It may be effective at reversing hemorrhage when administered promptly but injury may still occur.
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
Symptoms of uncontrolled bleeding may include:
- Severe pain in abdomen or stomach
- Vomiting with blood
- Black, tarry stools
- Abdominal swelling
- Excessive tiredness
- Vision changes or slurred speech
- Weakness on one side of body
At least 500 deaths have been caused by uncontrolled bleeding in patients taking Pradaxa and symptoms of uncontrolled bleeding should be treated as a medical emergency.
In 2014, Boehringer Ingelheim settled nearly 4,000 lawsuits regarding complications caused by Pradaxa use. While many claims were settled, some patients may have elected not to participate in the group settlement and more injuries or deaths due to Pradaxa may have occurred.
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.