Pradaxa Bleeding

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In 2012, Pradaxa had already been linked to over 500 deaths from Pradaxa bleeding. Pradaxa bleeding is a potentially fatal complication which can result from the drug’s anticoagulant, or blood-thinning, effects. Pradaxa bleeding is a significant issue among patients because the blood-thinning effect is a very difficult and time-consuming process to reverse. Patients suffering from extreme effects of Pradaxa bleeding will arrive at the emergency room of a hospital and end up bleeding to death even with all the medical attention they could possibly receive.

Pradaxa has only been on the market for two years but has made $1 billion for its manufacturer, Boehringer Ingelheim. However, the medical community is alleging that the drug’s approval process was not rigorous enough since there is no option available to reverse the fatal effects of Pradaxa bleeding.

The Approval and Acceptance of Pradaxa

Critics say that the harmful effects that have resulted from Pradaxa are because it was approved through a tightly controlled testing procedure. There is a difference between how a drug performs under highly specified and monitored conditions and its real-life application in medicine.

Boehringer Ingelheim had claimed to be working on an antidote for the dangerous Pradaxa bleeding effect but concluded it was not necessary. They cited a comparison between Pradaxa and Coumadin, another popular anticoagulant, as reason enough for neglecting the risk.

Pradaxa was approved by the Food and Drug Administration (FDA) in October of 2010. The drug was touted as a revolutionary replacement for Coumadin. Coumadin was in use for nearly 60 years and is used to prevent strokes for patients with heart rhythm disorder, also known as atrial fibrillation.

Pradaxa has an advantage over Coumadin since patients do not need to be monitored for diet and drug interactions. Coumadin requires frequent blood tests to ensure its efficacy. Pradaxa lacked this problem and also appeared to be more effective at preventing strokes for patients. Pradaxa’s efficacy and convenience helped it to become very successful with one year after being put to the market.

Pradaxa Bleeding Complications

Soon after the successful rise of Pradaxa in 2011, 542 deaths were reported to the FDA. Pradaxa was linked to injuries and death more than 800 other drugs that were being prescribed. These medications are closely monitored by the Institute for Safe Medication Practices based in Pennsylvania.

It was noted that internal hemorrhaging and internal bleeding are both dangerous complications associated with Pradaxa usage. This is also a risk associated with Coumadin, but unlike Pradaxa bleeding, internal bleeding from Coumadin can be treated with vitamin K. While there is no antidote for Pradaxa bleeding, the recommended treatment is to filter the medication out from the patient’s blood through dialysis. However, this is a largely ineffective approach to help Pradaxa bleeding.

Many health care professionals assert that Pradaxa bleeding makes the drug too risky for medical use. Even though the medication can help prevent stroke, Pradaxa bleeding makes it a less appealing approach than other medications that are currently available.

Risk Factors for Pradaxa Bleeding

While Pradaxa bleeding is a risk for any patient being prescribed to the drug, there are certain risk factors that patients should be aware of before beginning their treatment. Assessing these risks can help prevent the possibility of experiencing the potentially fatal Pradaxa bleeding complications.

Pradaxa bleeding risk factors:

  • Kidney problems
  • Patients older than 75
  • Gastrointestinal problems such as ulcers or intestinal bleeding
  • Low body weight

Because of Pradaxa bleeding, patients need to be monitored for other drugs that are used. Many other medications also have an effect on blood coagulation. For example, aspirin and other non-steroidal anti-inflammatory medications are contraindicated for use with Pradaxa because of Pradaxa bleeding.

View Sources

  1. United States. Food and Drug Administration. FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran). 2012. Web. 12 Apr 2013. http://www.fda.gov/Drugs/DrugSafety/ucm326580.htm
  2. Thomas, Katie. “A Promising Drug With a Flaw.” New York Times. N.p., 02 Nov 2012. Web. 12 Apr 2013. http://www.nytimes.com/2012/11/03/business/a-rising-anti-stroke-drug-is-tied-to-risk-of-bleeding-deaths.html?_r=1&
  3. Silverman, Ed. “Was The FDA Safety Analysis For A Popular Bloodthinner Flawed?.” Forbes. N.p., 06 Nov 2012. Web. 12 Apr 2013. http://www.forbes.com/sites/edsilverman/2012/11/06/was-the-fda-safety-analysis-for-a-popular-bloodthinner-flawed
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