March 8, 2012 — Doctors are warning that elderly people who are taking Pradaxa may have a higher risk of bleeding to death after a fall. Unlike other anti-clotting drugs, such as warfarin, only 2-3 hours of dialysis can reverse the blood-thinning effects of Pradaxa. An elderly person who falls may begin to bleed uncontrollably because their blood is unable to clot. Even if they go to the hospital, a doctor may be unable to stop the bleeding before it causes permanent disability or death. The FDA is now investigating numerous reports of internal bleeding and hemorrhaging linked to Pradaxa.
Each year, one out of three Americans 65 years or older falls. The risk of falling increases with age because balance normally deteriorates with age. Severe falls can cause hip fractures, head trauma, and deadly traumatic brain injuries.
Elderly people are also more likely to suffer from atrial fibrillation, a type of irregular heartbeat that can cause blood clots to form in the heart, which may then cause strokes. Millions of people take an anti-clotting drug to prevent stokes, such as Pradaxa.
There is now growing evidence that elderly people may more more likely to die from a fall if they are taking Pradaxa. A recent New Zealand study investigated a cluster of bleeding events, and found that elderly people (over 75) who had impaired renal function were far more likely to suffer serious bleeding while taking Pradaxa.
In the past, most people with atrial fibrillation took warfarin (brand-name Coumadin) to prevent strokes. Warfarin is a notoriously difficult medication. It causes large numbers of elderly hospitalizations every year, mostly because it has a high risk of bleeding and is difficult to administer. People must use blood tests to adjust dosage. Warfarin is also inactivated with Vitamin K, commonly found in many foods. However, if a person taking warfarin suffers a fall and begins to bleed, it is easy for a physician to administer a dose of Vitamin K to inactivate warfarin and stop the bleed.
Unlike warfarin, Pradaxa has no reversal agent. Once bleeding starts, it may be irreversible. Even minor falls could be deadly for people taking Pradaxa. Recently, an 83 year-old man taking Pradaxa died after a minor fall. The man hit his head, and when doctors performed a CT scan, they saw minor bleeding in his brain. The doctors used traditional methods to stop the bleeding — intravenous fluids and a protein called recombinant factor VIIa. These methods were completely ineffective. The man continued to bleed. Blood filled the entire left side of his brain, and a large portion of the right. Within six hours, he lapsed into a coma and died.
The doctors treating him later published a report, because they were concerned that the number of deaths from minor falls would increase as more and more elderly people began taking Pradaxa instead of warfarin. The doctors said, “Imbalance and falls are common in this population, and intracranial hemorrhage resulting even from minor trauma may occur with increasing frequency as use of this drug becomes more widespread.”
The only recognized way to stop bleeding in people who are taking Pradaxa is dialysis. This presents difficulties, however. When a patient appears at the hospital, it takes time for a doctor to diagnose bleeding in the brain, recognize that the patient is taking Pradaxa, and order dialysis. With dialysis, it still takes two to three hours to remove 30-60% of Pradaxa from the bloodstream. This can be even more difficult if a patient has impaired renal function. By the time dialysis takes effect, a patient may suffer permanent disability or death.
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