Pradaxa (dabigatran) is a new blood-thinning medication invented by the drug company Boehringer Ingelheim. Since it was approved in 2010, Pradaxa has been linked to hundreds of deaths, many caused by gastrointestinal bleeding. Pradaxa GI bleeding can be fatal, because Pradaxa inhibits blood clots.
Need a Texas Pradaxa Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by severe bleeding, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
UPDATE: Pradaxa Linked to 28% More GI Bleeding than Warfarin
May 13, 2014 — Pradaxa is associated with a 28% higher rate of gastrointestinal bleeding than warfarin, but lower rates of stroke and death, and similar rates of heart attack, according to a Safety Communication published by the FDA. Click here to read more.
Pradaxa (dabigatran) is a new type of blood-thinner that is prescribed to adults with atrial fibrillation, a type of “fluttering” heartbeat that is associated with a higher risk of blood clots and deadly ischemic strokes. Pradaxa is the first major competitor to Coumadin (warfarin), a problematic blood-thinning medication that has been around for several decades. Pradaxa is a once-daily pill, while warfarin requires blood testing to adjust dosage. Both medication have a risk of bleeding. Unfortunately, there is growing evidence linking Pradaxa to serious risks of gastrointestinal bleeding.
Boehringer Ingelheim, the manufacturer of Pradaxa, is currently creating a registry of people with atrial fibrillation. The study will not be completed until 2020. Over the next eight years, researchers will be monitoring the risk of side effects among people taking Pradaxa, Xarelto, aspirin, and warfarin to see whether there are long-term safety risks of using any of these drugs to prevent strokes associated with atrial fibrillation.
Pradaxa and Gastrointestinal Bleeding
Like all blood-thinners, one side effect of Pradaxa is internal bleeding. The problem with Pradaxa is that the risk of severe Pradaxa GI bleeding may be higher than for other blood thinners. One study of people who switched from warfarin to Pradaxa showed a significantly higher risk of bleeding when the patients were taking Pradaxa. One patient in the study died from Pradaxa GI bleeding.
Many studies have highlighted the risk of prescribing Pradaxa to elderly people, especially those who have impaired kidney function. When the kidneys do not efficiently remove Pradaxa from the bloodstream, it can build up to life-threatening levels. High amounts of Pradaxa in the bloodstream significantly increase the risk of a deadly Pradaxa gastrointestinal bleeding event.
Another risk is that Pradaxa has no effective reversal agent, unlike warfarin. In an emergency, the only way to remove Pradaxa and reverse the anti-clotting effects is with dialysis. Dialysis can take several hours to take effect. Severe and deadly blood loss can easily occur in this time.
What is Gastrointestinal Bleeding?
Gastrointestinal bleeding is a severe, life-threatening medical condition that occurs when there is bleeding anywhere along the gastrointestinal (GI) tract. The GI tract is divided into an upper and a lower section. The upper GI tract includes the esophagus, stomach, and the first part of the small intestine. The lower GI tract includes most of the small intestine, large intestine (bowel), rectum, and anus.
Pradaxa GI bleeding can occur anywhere along the entire GI tract. It can be very difficult for a physician to locate the source of the bleeding, and stopping it can be even more difficult. Pradaxa is a blood-thinner, which inhibits the formation of blood clots. Unless the body forms a blood clot, a person who suffers from gastrointestinal bleeding will bleed to death.
Approximately 50-150 people per 100,000 suffer from upper gastrointestinal tract bleeding every year. One study from 2007 found that 7% of people who suffer acute gastrointestinal bleeding die from the condition.
Signs & Symptoms of Pradaxa Gastrointestinal Bleeding
Symptoms of gastrointestinal bleeding vary depending on the size and source of the bleed. The amount of blood also varies. Sometimes, Pradaxa GI bleeding shows very few symptoms, and it is not diagnosed until a person becomes anemic. Other times, GI bleeding can result in severe blood loss and death. Typically, the closer the bleed is to the anus, the brighter red the blood.
Common symptoms of Pradaxa gastrointestinal bleeding include, but are not limited to:
- Abdominal pain
- Blood in the stools
- Large amounts of blood passing from the rectum
- Blood in the toilet bowl, on stools, or on toilet paper
- Black, tarry stools
- Vomiting blood
- Vomiting a substance that resembles coffee grounds
- Low blood count
Need a Pradaxa Lawyer in Texas?
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