Pradaxa Linked to Blood Clots, Bleeding
Boehringer Ingelheim Pharmaceuticals has stated that most of the deaths from Pradaxa blood thinner were caused by severe bleeding complications. An updated list of fatalities was issued following an inquiry from Japan, where dozens of deaths have been associated with Pradaxa use.
In response to this alarming trend, Japan has called on Boehringer Ingelheim Pharmaceuticals drug company to adequately warn patients on the labeling of Pradaxa blood thinner.
Taking the high number of deaths into consideration, researchers have questioned the validity of Pradaxa clinical trials, stating that the dangerous drug should never have been approved because the studies were flawed.
Pradaxa was designed as a replacement for Coumadin (generic: warfarin), but is supposed to require less patient monitoring and be easier to use. The FDA approved Pradaxa in 2010.
However, warfarin can be counteracted with Vitamin K when someone suffered severe bleeding. This does not work with Pradaxa or any of the other newer blood thinners such as Xarelto (generic: rivaroxaban).
This new class of medications - which also includes Eliquis (Bristol-Myers Squibb and Pfizer) and Lixiana (Daiichi Sankyo) - are used to prevent strokes in patients suffering from atrial fibrillation, or a-fib, a type of irregular heartbeat common among the elderly. All of these drugs are competing for a market estimated to be worth between $10 and $20 billion annually.
Like other blood-clotting agents, Pradaxa’s ability to treat massive strokes comes at an increased risk of excessive bleeding, which can also be fatal. It has been theorized that Pradaxa may have too much of an effect on the blood clotting process, which leads to hemorrhages.
There have also been conflicting reports indicating that the drug does not have enough of an effect on clotting, resulting in pulmonary embolisms and deep vein thrombosis (DVT).
In recent studies, Pradaxa uncontrollable bleeding side effects included:
- Any bleeding - in up to 16.6% of people taking Pradaxa (compared to 18.4% with warfarin)
- Major (serious) bleeding - up to 3.3% (compared to 3.6% with warfarin)
- Life-threatening bleeding - up to 1.5% (compared to 1.9% with warfarin)
- Bleeding in the brain - up to 0.3% (compared to 0.8% with warfarin)
In Europe, emergency room doctors and medical professionals have been advised to test Pradaxa patients’ kidney functions to reduce chances of life-threatening bleeding complications before starting Pradaxa. The drug was approved for use in the United Kingdom on November 1, 2011. In the U.S., Pradaxa was approved for use in October 2010, and has since received more customer complaints to the U.S. Food and Drug Administration (FDA) than about 99% of the other drugs on the market.
According to the Institute for Safe Medication Practices (ISMP), FDA received hundreds of reports of Pradaxa side effects within weeks of the drug being released.
Most of these side effects were gastrointestinal bleeding problems in elderly patients taking Pradaxa. In total, the agency received over 300 complaints about Pradaxa in the last quarter of 2010 alone, compared to just 202 complaints with warfarin and other blood thinners.
Side Effects of Pradaxa
Pradaxa has been associated with the following serious side effects:
- Serious internal bleeding
- Serious internal hemorrhaging
- Bleeding disorders
- Rectal bleeding
- Brain bleeds
- Cerebral hemorrhaging
- Heart attack
- Atrial fibrillation
- Digestive tract ulcers
- Kidney failure
- Pulmonary embolism
- Deep vein thrombosis
Moderate side effects of Pradaxa may include:
- Abdominal (stomach) pain
- Gastroesophageal reflux disease (GERD)
- Ulcers of the digestive tract
Pradaxa Fatal Bleeding Events
An analysis of internal bleeding injuries among Pradaxa users suggests that the risks of the medication may be greater than any potential benefit.
The review, which was published in the Feb. 2012 online edition of the Journal of the American College of Cardiology, identified 78 serious bleeding events during the 60 day review period, including 44 cases handled by the panelists personally. Of these 44, at least 12 were classified as ‘severe.’
One of the major contributing factors to the internal bleeding events identified by the panel was that of prescriber error. A number of doctors were found to have prescribed Pradaxa to patients with pre-existing kidney damage, which has previously been identified as being one of the four major factors contributing to internal bleeding.
Impaired renal function makes it difficult for the body to filter out Pradaxa’s blood-thinning agents, thereby increasing the chance that internal bleeding events will become progressively severe.
In the RE-LY clinical trial, which the FDA used as justification for Pradaxa’s approval, less than 20% of the test subjects had prior kidney damage, compared to nearly 60% of the population from the new review.
Federal Judge in Southern District of Illinois Closes Pradaxa MDL
Before the Pradaxa settlement, a judicial panel consolidated most Pradaxa lawsuits against Boehringer Ingelheim into a Pradaxa multidistrict litigation (MDL) in the Southern District of Illinois. A judge in the United States District Court for the Southern District of Illinois managed the Pradaxa lawsuits.
U.S. District Court Judge David Herndon planned to conduct 4 trials in the multidistrict litigation. The trials were to happen between August 2014 and February 2015.
Herndon selected the blood thinner Pradaxa Lawsuits against Boehringer Ingelheim to help attorneys determine the effectiveness of their arguments. Two Pradaxa Lawsuits in the multidistrict litigation district court were wrongful death lawsuits. Two blamed the drug for severe injuries.
But the trials never started. Boehringer Ingelheim Pharmaceutical USA settled the cases instead of moving forward in the multidistrict litigation. Herndon closed the MDL in December 2017 after the last case was resolved.
Law firms continue to file individual lawsuits. If a large number of people claim the same drug injured them, a judicial panel may group the cases.
Pradaxa Labels Updated in Canada
Canadian health regulators have required new warning labels to be added to Pradaxa indicating the risk of internal bleeding may be increased in patients with kidney problems.
Health Canada also indicated that Pradaxa should not be used on individuals with rheumatic valvular heart disease, mitral valve stenosis, or prosthetic heart valves, as the safety of Pradaxa has not been tested in patients with these complications.
The new Canadian warnings are based on post-marketing reports of internal bleeding among elderly individuals being treated with Pradaxa, especially those with severe kidney problems. The level of kidney impairment can be determined by calculating the person’s creatinine clearance (CrCl). A CrCl of less than 30 mL/min is designated as severe renal damage.
Brain Hemorrhage Death
The death of an elderly man from brain hemorrhage after a routine ground level fall suggests that bleeding complications from Pradaxa may be irreversible.
Three University of Minnesota doctors evaluated the events that led to the death of an 83-year-old man for what initially was seen as a routine fall, according to the Journal of Neurosurgery.
When the man was first admitted to the university’s medical center, he was fully alert and in control of his faculties, and his neurological examination showed no findings of great concern. CT scans revealed tiny superficial areas of hemorrhage in the brain, but within hours new scans revealed extensive progression of hemorrhaging. Unfortunately, efforts to reverse the complications proved ineffective, as the patient fell into a coma and subsequently died.
"In the event of traumatic hemorrhage in patients receiving dabigatran ... there are currently no effective reversal agents" to neutralize the drug, the report said.
Having an intimate understanding of Pradaxa interactions is of critical importance for medical personnel when using the drug to control bleeding, the report said.
The researchers speculated that emergency dialysis may be able to remove up to 60% of Pradaxa from the bloodstream in 2 to 3 hours, but that option was not used with the elderly patient.
Due to the fact that patient falls and general motor coordination problems are common in elderly individuals, brain hemorrhages from even minor trauma are likely to increase as more patients undergo treatment with Pradaxa, the report said.
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Again, if you or a loved one suffered a major bleeding event or other adverse events after taking Pradaxa, you should contact our law firm immediately. You may be entitled to seek compensation for medical expenses by filing a Pradaxa lawsuit and our lawyers can help.