People who take Pradaxa have a higher risk of bleeding, especially bleeding in the rectum. There is emerging evidence that people who are over 75 years old, have kidney problems, or impaired renal function, have an even greater risk of suffering major rectal bleeding while taking Pradaxa. Rectal bleeding is a potentially life-threatening side effect of using Pradaxa.
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Pradaxa (dabigatran) is a prescription medication intended to prevent strokes caused by blood clots that form in the heart due to atrial fibrillation. Pradaxa is the first direct thrombin inhibitor. It inhibits the enzyme thrombin, which is necessary for blood platelets to stick together.
Unfortunately, Pradaxa also carries a risk of serious bleeding, including rectal bleeding. Some experts are concerned that Pradaxa was rushed to market, and there was not enough foresight or planning before it became widely available. Since 2010, when the U.S. Food and Drug Administration (FDA) approved Pradaxa for atrial fibrillation, there have been hundreds of deaths directly caused by Pradaxa. Dozens of people have suffered serious bleeding, and the risk appears to be greatest for elderly people.
The FDA is now investigating reports of serious bleeding. Doctors in New Zealand have already found that general practitioners have been prescribing Pradaxa to people over 75 years old with impaired kidney or renal function. Elderly people with these conditions have the highest risk of suffering severe rectal bleeding and other serious bleeding disorders.
Pradaxa and Rectal Bleeding
“Bleeding from the rectum” is listed as one potential Pradaxa side effect in the medication guide, though the guide says that this side effect is rare. It may actually be more likely for elderly people. Elderly people are more likely to have low body weight and impaired renal function, which increases their risk of suffering from rectal bleeding.
Rectal bleeding, technically referred to as “hematochezia,” occurs when blood vessels in the rectum rupture, causing bleeding in the rectum. The rectum is the last part of the large intestines before the anus. When the rectum is bleeding, blood is typically bright red, though it may be maroon or tarry. The severity of the bleeding also varies. It may be just a few drops, or the person may pass large amounts of blood in multiple bowel movements.
The problem with rectal bleeding in people taking Pradaxa is that it may be very difficult to stop this bleeding. Pradaxa is an anti-clotting agent, which naturally prevents blood from coagulating. Unfortunately, blood clots are necessary to stop bleeding.
The blood-thinning effects of Pradaxa can only be reversed with dialysis, which can take 2-3 hours to remove 30-60% of Pradaxa from a patient’s bloodstream. If a person who is taking Pradaxa starts bleeding, it may be very difficult or impossible for a physician to stop the bleeding before the patient bleeds to death. By the time the anti-clotting effects of Pradaxa are reversed, a patient can easily bleed to death. In comparison, the anti-clotting effects of warfarin can be reversed with Vitamin K.
RE-LY Study of Pradaxa
Dr. Michael Ezekowitz, a researcher who conducted clinical trials of Pradaxa, said that “Pradaxa triggers a 6% rate of major internal hemorrhages during every year of treatment.”
During the RE-LY safety study, researchers found the following rates of bleeding:
- 16.4% of people taking Pradaxa experience bleeding
- 3.3% experience serious bleeding
- 1.5% experience life-threatening bleeding
- 0.3% experience life-threatening bleeding in the brain.
- 17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding
It is notable that more than 17% of people who needed emergency surgery had major bleeding. Because Pradaxa has no quick reversal agent, people who are injured or begin to bleed may start bleeding uncontrollably because Pradaxa inhibits blood clotting.
Pradaxa Side Effects
Other Pradaxa side effects include:
- Heart attack
- Hemorrhagic stroke
- Cerebral hemorrhage
- Internal bleeding
- Gastrointestinal bleeding
- Rectal bleeding
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