Pradaxa Lawsuit in North Carolina
Before Pradaxa came on the market, Warfarin (brand name Coumadin) was prescribed in the treatment or prevention of venous thrombosis, blood clots, and pulmonary embolism. But it also can create a different deadly condition: excessive bleeding. It doesn’t take much to push a patient into dangerously high prothrombin ratio (INR) levels, and so healthy patients need to have blood tests weekly or at least monthly, and hospitalized patients need to be monitored every few hours. Warfarin is thus both a wonder drug which has saved the lives of many persons diagnosed with pulmonary embolism and a double-edged sword, because it causes major bleeding episodes in 3-5% of people taking it. Scientists have been trying to find safer replacements for the whole fifty years that its been used.
Pradaxa (dabigatran etexilate), manufactured by Boehringer Ingelheim Pharmaceuticals, was supposed to be one of those replacements. In September 2009, the initial results of the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study sponsored by the company were released, with the study’s authors — the bulk of whom received ”consulting fees, lecture fees, and grant support from Boehringer Ingelheim” finding:
We compared two doses of dabigatran with warfarin in patients who had atrial fibrillation and who were at risk for stroke. As compared with warfarin, the 110-mg dose of dabigatran was associated with similar rates of stroke and systemic embolism and lower rates of major hemorrhage; the 150-mg dose of dabigatran was associated with lower rates of stroke and systemic embolism but with a similar rate of major hemorrhage.
Note the use of the word “similar” in the study’s conclusion. It’s not a scientific term, it’s a term of art. In fact, when the RE-LY study came out, there was already concern among the FDA advisory panel members that the drug didn’t really offer an improvement over warfarin in preventing stroke in patients with atrial fibrillation, but rather offered just a different balance of the risk of bleeding versus the risk of stroke. In other words, a 110-mg dose was substantially less effective than warfarin in reducing strokes, while the 150-mg reduced strokes but had the same bleeding rates as warfarin.
On the surface, that makes it sound like Pradaxa is an improvement over warfarin, but it’s not the whole story. If a patient has overdosed on warfarin and starts to bleed, the effects can be quickly reversed with a dose of Vitamin K. If a patient overdoses on Pradaxa and starts bleeding, there’s nothing anyone can do but wait for their kidneys to process the Pradaxa and excrete it in the urine a process that takes hours at best, potentially longer if Pradaxa has slowed kidney function, as many people expect it can.
Based on the RE-LY conclusions, in October 2010 the FDA approved Pradaxa “for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).” The FDA-approved warning label, however, only mentioned Pradaxa can cause serious and, sometimes, fatal bleeding, without mentioning the key part: that a Pradaxa overdose, unlike warfarin, can’t be reversed. In the tiny print buried deep in the “full prescribing information,” it mentions that dialysis can be attempted, but admits “data supporting this approach are limited.” If a patient slips into excessive Pradaxa levels — which is a real risk, given that Pradaxa affects kidney function and given that Pradaxa’s primary marketing “hook” to doctors and patients was the claim that INR levels don’t need to be checked as frequently — then there’s no treatment.
It’s even worse given how Pradaxa’s label also admits, again in tiny print buried in the prescribing information, that “risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs),” which a large number of the target patients are taking.
In February 2011, the American College of Cardiology Foundation and American Heart Association added it to the guidelines of non-valvular atrial fibrillation. Sales skyrocketed — and so did adverse drug events. The Institute for Safe Medication Practices reported that, in the first quarter of 2011 alone, “Dabigatran (PRADAXA), a new drug approved to reduce the risk of stroke by inhibiting blood coagulation, generated a strong signal illustrating the substantial bleeding risks of this treatment, with more than 500 reports of fatal, disabling and other severe hemorrhages.”
Reports of internal bleeding, kidney failure, heart attack, and other blood thinning complications including death continued to mount, so that in December 2011 the FDA announced it was evaluating the post-marketing data on Pradaxa, with a warning to doctors to closely monitor renal function and a warning to patients about reporting any signs of bleeding (e.g., the gums, the nose, coughing, etc) to their doctor.
A month later, in January 2012, Boehringer Ingelheim updated part of the fine print on its label, but not by much. The new label admits that “protamine sulfate and vitamin K” are useless in treating a Pradaxa overdose, then speculates about various ways an overdose can be treated, including the use of various recombinant protein factors, although the label admits “their use has not been evaluated in clinical trials.”
In March 2012, the Journal of Neurosurgery published a case report explaining how neurosurgeons were completely unable to treat “an elderly patient, being treated with dabigatran [Pradaxa] for atrial fibrillation, who presented with a rapidly expanding intracranial hemorrhage after a ground-level fall.” In the course of six hours, the patient’s brain bleed expanded extensively, despite attempting treatments like recombinant factor VII. The authors concluded, “in the event of catastrophic hemorrhage no effective reversal agent exists.” Put simply, if a patient on Pradaxa suffers a serious trauma, doctors are helpless to treat it.
Pradaxa became the subject of investigation in New Zealand in September 2011, after as many as five elderly patients died after experiencing internal bleeding. In addition to these patients, another 36 patients reportedly suffered serious internal bleeding. In the New Zealand media, some families claimed that when their family members switched from warfarin to Pradaxa, their conditions deteriorated to the point of hospital admission and they died of infections.
These reports in New Zealand came just weeks after Japanese regulators requested that the maker of Pradaxa notify healthcare providers about the potential for fatal bleeding in some patients. In a letter sent to Boehringer Ingelheim by the Japanese health ministry, it was stated that 81 elderly patients suffered bleeding caused by Pradaxa between March 14 and August 11. Five of these patients died. As a result of these incidents, Japanese regulators suggested that patients over the age of 70 may require a lower dosage of this drug.
It should be noted that bleeding is also a side effect of other blood thinners, such as warfarin. However, warfarin bleeding can be treated with Vitamin K, while there is no antidote for bleeding from Pradaxa and other drugs known as thrombin inhibitors.
Some patients are more susceptible to internal bleeding and hemorrhaging. If you have one of the following conditions, your risk of Pradaxa side effects may be higher:
- If you are 75 years old or older.
- If you take medications such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDS, or blood thinners, which may increase your risk of bleeding.
- If you have kidney issues.
- If you have recent and recurring stomach or intestinal bleeding or if you have a stomach ulcer.
If you take Pradaxa and experience any of these symptoms of internal bleeding, you are advised to seek immediate medical care:
- Bleeding from the gums
- Coughing up blood
- Frequent nosebleeds
- Joint pain or swelling
- Pink or brown urine
- Red or black tarry stools
- Unusual bruising or bleeding
- Vomiting that resembles blood or looks like coffee grounds
- Weakness and swelling of the arms, hands, feet, ankles or lower legs.
You should always consult with your doctor before stopping any medication.
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