Pradaxa (dabigatran) is an anticlotting drug, approved by the U.S. Food and Drug Administration (FDA) in October, 2010. It was the first of the novel oral anticoagulants (NOACs) prescribed as alternatives to warfarin. Pradaxa is more convenient for patients and their doctors. It is thought to have fewer side effects and be more effective in preventing stroke than warfarin, but for the first five years that Pradaxa was on the market there was no antidote that could stop the anticlotting effects during a bleeding event.
Pradaxa is prescribed to reduce the risk of blood clot formation and stroke in people with a heart rhythm abnormality called nonvalvular atrial fibrillation (AFib). It is also used to treat and prevent recurrence of dangerous blood clots in the legs, called deep vein thrombosis (DVT), and in the lungs, called pulmonary embolism (PE).
When Pradaxa hit the market, it was met with enthusiasm because it was the first alternative to warfarin. Warfarin use requires routine blood monitoring and carries dietary restrictions making it inconvenient and often frustrating for patients and doctors.
Pradaxa use does not carry dietary restrictions or require routine blood monitoring, although studies have found that blood monitoring reduces the risk of dangerous and deadly bleeding events when taking Pradaxa.
Pradaxa Side Effects
Common side effects of Pradaxa include:
- Stomach pain
More serious side effects and risks of Pradaxa use include:
- Bleeding events, which can be fatal
- Spinal or epidural blood clots which can cause paralysis
- Heart attack or acute coronary syndrome
- Liver failure
Like all blood thinners, including warfarin, Pradaxa can cause major bleeding events. When someone taking an anticlotting drug suffers trauma, even a minor injury can become serious or fatal due to excessive bleeding.
When Pradaxa hit the market, there was no antidote or reversal agent, so emergency room doctors were helpless to stop the bleeding and hundreds of patients died from Pradaxa bleeding. In 2015, an antidote called Praxbind (idarucizumab) was approved through the FDA’s accelerated approval program.
In addition to uncontrolled bleeding from trauma, Pradaxa can cause spontaneous bleeding including:
- Internal bleeding
- Gastrointestinal bleeding
- Hemorrhagic stroke
Pradaxa Heart Attack Risk
In 2012, researchers from Cleveland Clinic published results of a study which found that Pradaxa users were 33% more likely to have a heart attack or acute coronary syndrome than people taking warfarin or a placebo. The study findings were published in the Archives of Internal Medicine.