Pradaxa (dabigatran) is an anticlotting medication, approved in October, 2010 by the U.S. Food and Drug Administration (FDA). Pradaxa was the first of novel oral anticoagulants (NOACs) prescribed as alternatives to warfarin. The medication is more convenient or patients and their physicians. It’s considered to have fewer side effects and be far more successful in preventing stroke compared to warfarin, but for the first five years that it was on the market there was no antidote that could stop the anticlotting effects during a bleeding event.
Pradaxa is prescribed to decrease the risk of blood clot formation in patients with a heart rhythm abnormality called nonvalvular atrial fibrillation (AFib. It’s 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 excitement as it was the very first substitute to warfarin. Warfarin use requires routine blood monitoring and includes dietary limitations making it inconvenient and frequently frustrating for patients and doctors.
Pradaxa use doesn’t carry dietary limitations 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 most of blood thinners, such as warfarin, Pradaxa can cause major bleeding events. When patients taking an anticlotting medication suffer trauma, even a minor injury can become severe or deadly as a result of excessive bleeding.
When Pradaxa hit the market, there was no antidote, alteration or reversal agent, so doctors were unable to stop the bleeding and hundreds of patients died from Pradaxa bleeding.
Besides uncontrolled bleeding from injury, Pradaxa could cause spontaneous bleeding such as:
- Internal bleeding
- Gastrointestinal bleeding
- Hemorrhagic stroke
Pradaxa Heart Attack Risk
In 2012, researchers from Cleveland Clinic released results of a study which discovered that Pradaxa consumers were 33 percent more likely to have a heart attack or severe coronary disease compared to individuals taking warfarin or a placebo. The study findings have been published at the Archives of Internal Medicine.