Bleeding Risks Associated with Pradaxa

PillsOur friends at want to make sure those of you on Pradaxa are aware of the risks of this drug.  Pradaxa was designed to take the place of warfarin or coumadin as the blood thinner of choice because it does not require blood monitoring through lab draws (it is also a patented drug and costs lots and lots thereby greatly benefiting Boehringer Ingeleheliem).  Pradaxa works by inhibiting thrombin directly and preventing the formation of a clot and is primarily used in patients with atrial fibrillation.  The problem is there is no way to reverse the inhibition and restore the ability to clot in the event of an untoward event and there have been numerous fatalities due to uncontrolled bleeding. Pradaxa is no more effective than coumadin or warfarin (long off patent and dirt cheap), which can be easily reversed by the administration of vitamin K.  Pradaxa costs much, much more than warfarin, is dangerous and no more effective.  If you are on Pradaxa, I suggest you read this article and consider asking your doctor to change you to the much safer warfarin.

Around 2 million people take blood thinners to decrease the risk of heart attack and stroke. Blood thinners work by preventing blood clots from forming in the arteries and veins. Unfortunately Pradaxa, a commonly prescribed blood thinner, puts people at a high risk of uncontrollable bleeding accidents and was associated with 3,781 serious adverse events in 2011, including 542 deaths.

Understanding the risks involved with bleeding injuries, the consequences of Pradaxa use and how to avoid accidents can assist you in safely taking this blood thinner.

No Antidote for Bleeding Events

All blood thinners inhibit the body’s natural ability to clot – a necessary part of healing when it comes to cuts or injuries—but not all blood thinners have antidotes to reverse this mechanism in case of emergency. While blood thinners can prevent strokes and treat heart conditions, they also leave users vulnerable to bleeding.

Warfarin, a blood thinner that has been the standard treatment for more than 50 years, has an antidote in case of emergency. Although the medication requires some diet changes and regular blood tests, vitamin K can be administered  to stop bleeding if it occurs.

For those who take Pradaxa (dabigatran), which has been available since October 2010, no antidote exists, making uncontrollable bleeding from even minor wounds a serious health hazard.

Numerous Reports of Bleeding Events

The Food and Drug Administration (FDA) and QuarterWatch, a publication for the nonprofit Institute of Safe Medication Practices, have received thousands of reports of adverse events related to Pradaxa. In 2011, QuarterWatch gathered reports from manufacturers, physicians and medical databases and found 3,781 Pradaxa adverse events. In these reports, there were 500 serious or disabling bleeding events and 542 fatalities.

After experiencing side effects like severe hemorrhaging, Pradaxa patients and their families have filed lawsuits against the drug’s manufacturer, Boehringer Ingelheim. As of November 2012, nearly 200 people had filed lawsuits over Pradaxa. Since bleeding continues to be a serious risk of Pradaxa, more lawsuits are expected to follow.

Avoiding Bleeding Events

Anyone taking a blood thinner should take extra measures to avoid bleeding injuries. Cuts, falls and internal bleeding can escalate quickly when taking these drugs. So, here are some guidelines for preventing accidents:

To prevent indoor injuries:

  • Work at a slow pace, in good lighting, and avoid distractions when using scissors and knives.
  • Use electric razors instead of razors with exposed blades.
  • Trim toe nails from a stable location, and make sure the area is well-lit.
  • Wear shoes or non-skid slippers in the house instead of walking barefoot or in socks.

To prevent outdoor injuries:

  • Wear safety gloves when working with sharp tools.
  • Refrain from dangerous sports or activities.
  • Use gloves even for simple gardening tasks.
  • Wear close-toed shoes instead of sandals.



Alanna Ritchie is a content writer for and writes about prescription drugs, medical devices and consumer safety.

Marsha Nunley MD
Marsha Nunley MD
I am an internist, trained and experienced in Western Medicine, who believes that illness and disease are best treated by working to discover their underlying causes. Come to me for bioidentical hormones, advice on healthy aging, and whole-body medicine.