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Pradaxa® (generic name: dabigatran etexilate mesylate) was approved by the FDA in October 2010 as an anticoagulant, a drug that helps keep the blood from clotting, for individuals who have a specific heart rhythm problem called atrial fibrillation (AF).

Now, the FDA is investigating reports of uncontrollable bleeding and other serious bleeding events in AF patients who were being treated with Pradaxa®. A December 2011 Safety Announcement from the FDA notes, “At this time, FDA continues to believe that Pradaxa® provides an important health benefit when used as directed,” but many public health officials are concerned about the rise in Pradaxa®-related internal bleeding events and deaths.

Life-Threatening Internal Bleeding Events

The most prominent danger presented by Pradaxa® is the fact that there is no reversal agent for it. That is, unlike its predecessor drug warfarin (an anticoagulant medication that has been used for decades), when a Pradaxa®-treated patient is bleeding too much (for whatever reason), there is no drug that can be administered to successfully stop the bleeding. He or she may continue bleeding or hemorrhaging until organ damage, coma, and/or death occur.

Death from Pradaxa® Bleeding

In fact, several reports of deaths linked to Pradaxa® treatment have been published. For example, an elderly Utah man who took a minor fall in February 2012 was admitted to the hospital for a routine examination, and doctors found that his brain was bleeding uncontrollably. The man’s Pradaxa® treatment made efforts to stop the bleeding ineffective, and since there is no reversal agent for Pradaxa®’s effects, his bleeding continued, resulting in his death.

Other Serious Pradaxa® Side Effects

Although at this time the FDA states that the benefits of Pradaxa® when used appropriately outweigh the risks of this drug, there are other serious Pradaxa® side effects in addition to uncontrollable bleeding. These include:

  • coughing up blood or blood clots
  • vomiting blood or vomit that looks like coffee grounds
  • menstrual or vaginal bleeding that is heavier than normal
  • unusual bleeding from the gums
  • heart attack

A clinical study of 18,000 patients found that Pradaxa® treatment produced a 38 percent higher risk of heart attack compared to warfarin.

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