March 8, 2012 — The recent death of an elderly American man highlights the increased risk of death from falling in people who are taking Pradaxa, a new anti-clotting drug that has no reversal agent. Elderly people are more likely to fall, and also more likely to take Pradaxa — a potentially deadly combination. Minor bleeding from falls may be unstoppable in Pradaxa patients, leading to severe hemorrhage and death.
Every year, one-third of Americans over the age of 65 falls, and the risk increases with age. Falling can cause hip fractures, head trauma, and increases the risk of death. In fact, falls are the leading cause of injury deaths for people over 65 years of age.
Many older Americans also suffer from atrial fibrillation, a type of irregular heartbeat that increases the risk of stroke, and so they take an anti-clotting drug to reduce the risk of stroke. A growing number of elderly Americans are taking Pradaxa. Unfortunately, Pradaxa has no effective reversal agent. This means that when an elderly person falls and begins to bleed, Pradaxa may inhibit necessary blood clots, causing uncontrollable bleeding that cannot be stopped. The FDA is investigating numerous reports of serious bleeding linked to Pradaxa.
Recently, an 83 year-old man who was taking Pradaxa died from a minor fall in which he hit his head. The traumatic brain injury started as a minor bleed in his brain. Minor falls are the most common cause of traumatic brain injuries. Approximately half of the people who die from a fall suffer a traumatic brain injury.
The doctors who treated the elderly man were concerned that the number of deaths from minor falls will increase as more and more people begin taking Pradaxa instead of warfarin, an older anti-clotting drug. The blood-thinning effects of warfarin can be easily reversed with a dose of Vitamin K. Unlike warfarin, the blood-thinning effects of Pradaxa can only be reversed with dialysis.
The doctors warned, “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.”
If an elderly person taking Pradaxa falls and begins to bleed uncontrollably, a physician may be unable to stop the bleeding without dialysis. However, this presents problems. A doctor must know that the patient is taking Pradaxa and order dialysis immediately, because dialysis can take 2-3 hours to remove 30-60% of Pradaxa from the bloodstream. However, most doctors do not choose dialysis as a first-line treatment when presented with a patient who is bleeding. They use traditional methods to stop bleeding, such as giving intravenous fluids or a protein called recombinant factor VIIa. These methods are ineffective to stop bleeding in patients taking Pradaxa. By the time the doctor orders dialysis and Pradaxa is removed from the bloodstream, the patient may have already suffered life-threatening bleeding or become permanently disabled.
Pradaxa was widely hailed when it first became available. It was an alternative to warfarin, a notoriously difficult medication. Warfarin causes large numbers of elderly hospitalizations every year, mostly because it carries a risk of bleeding (equal to Pradaxa), requires frequent blood monitoring to adjust dosage, and interacts with foods containing Vitamin K (most green, leafy vegetables). Pradaxa, in comparison, is a once-daily pill.
Unfortunately, there is growing concern about the safety of Pradaxa, highlighted by a cluster of bleeding events in New Zealand that prompted an investigation. Doctors found that people over 75 years of age who had impaired renal function were significantly more likely to suffer severe bleeding. This population is also significantly more likely to fall. Doctors must consider these elevated risks when determining the risk-benefit of prescribing Pradaxa.
Do I have a Pradaxa Lawsuit?
The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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