Susan Garau, 61, was down with the flu last year when she was found incoherent and bleeding from her mouth while in bed.
By the time Garau arrived at Seven Oaks General Hospital in Winnipeg, the grandmother was hemorrhaging from several parts of her body including her mouth, intestines and brain.
"They were draining blood from the stomach, she was bleeding from her mouth … and by that evening she slipped into a coma and was bleeding everywhere,” recalls Garau’s daughter, Brigitte Pichon.
Garau had been taking Pradaxa -- a blood thinner used to treat a heart condition called atrial fibrillation.
The drug is one of a new class of oral anti-coagulants that don’t require regular blood tests. Pradaxa was approved for use in Canada in 2008.
Before Pradaxa was introduced, the only oral anti-coagulant available in Canada was warfarin, also known as Coumadin. It’s an older medication that requires regular blood tests and comes with many dietary restrictions.
Pradaxa was heralded as the first drug of its kind that did not require regular testing or diet restrictions. Studies show the drug is effective in stopping clots from forming, lowering the risk of stroke.
Some doctors, however, claim there may be very little that can be done to save someone on Pradaxa who suffers excessive bleeding since there is currently no antidote.
“One of the challenges with Pradaxa in particular is that if someone comes to hospital and they are bleeding we really have no way of turning it off. There is no antidote to the drug and that can sometimes have significant consequences,” says Dr. David Juurlink, a drug safety expert at Sunnybrook Health Sciences Centre.
While warfarin can also trigger life-threatening bleeding, doctors can administer an antidote containing vitamin K to patients, promoting clotting and counteracting the thinning effect of the drug.
There is no such solution for Pradaxa users.
Its manufacturer, Boehringer Ingelheim, warns that “patients should not stop taking their anticoagulant medication or any other medication without first talking to their health care providers. Discontinuing anticoagulation therapy puts a patient at increased risk of stroke.”
At Seven Oaks General in Winnipeg, Garau's condition deteriorated and she continued to bleed from her mouth and rectum. Her doctors were unsure with how to deal with the drug and they were unable to stop her bleeding, says her daughter.
Garau was placed in ICU and died on Jan. 20, four days after she was admitted.
Pichon claims she and her mother were never told that there is not an effective antidote, and her family blames the drug for triggering her death.
“That is the problem with this drug … and the most important fact … you can't reverse it. And that's what they left out,” she said.
Garau’s family is now suing Boehringer Ingelheim. The case is one of four filed in Canada so far.
Other reactions
According to the Health Canada Adverse Drug Reaction database, there have been more than 1,700 adverse reaction reports and 281 deaths linked to Pradaxa from the time the drug was approved for use in this country in 2008 up until December 2013. More recent reports are not yet available on Health Canada’s website.
The Institute for Safe Medication Practices says that in the U.S., Pradaxa has become the most complained about drug to the Food and Drug Administration. There are more than 1,000 deaths and 15,000 adverse reaction reports filed with the FDA, along with 2,450 lawsuits filed against the makers.
"I started hemorrhaging from my teeth, from my nose, and from my stool," says Paul Payne Jr., a litigant in the U.S.
In an interview with CTV News, Institute for Safe Medication Practices spokesperson Thomas Moore says those on the medication need to be “vigilant.”
"This drug now needs to be reassessed and it's not clear that it is safe," Moore said.
Boehringer Ingelheim has stood by the drug, noting that the FDA has upheld its safety and that its value has been proved in clinical trials.
STATEMENT TO CTV NEWS:
At Boehringer Ingelheim, patient safety is always our first priority. We are vigorously defending Pradaxa® in every lawsuit. This important medication is approved in more than 100 countries. Pradaxa reduces the risk of stroke, which is potentially debilitating and fatal in patients who suffer from the irregular heart rhythm condition known as atrial fibrillation.
Results from one of the largest international stroke prevention research programs involving 18,000 patients, demonstrated the safety and efficacy of Pradaxa and its superior benefits when compared to the leading competing blood thinner product.
Four statements of claim have been filed in Canada each naming as plaintiff a single patient on Pradaxa. These cases are all at an early procedural stage and none have been certified in court.
We are confident the evidence will show we acted appropriately and responsibly in our research, development and marketing of this important medication.
Additional background information:
At Boehringer Ingelheim, patient safety is our top priority. We are vigorously defending Pradaxa in each and every product liability case. This important medication is approved in more than 100 countries and when used as directed by the product label, Pradaxa reduces the risk of stroke, which can be debilitating and potentially fatal in patients that suffer from the irregular heart rhythm condition known as atrial fibrillation.
The efficacy and safety of Pradaxa are proven and well-documented in one of the largest international stroke prevention research programs involving 18,000 patients, demonstrating the superior benefits the treatment offers to people with irregular heart rhythms when compared to the leading competing blood thinner product.
All blood thinning medications carry an increased risk of bleeding, but for those with irregular heart rhythm, this must be balanced against the risk of a stroke. Patients should always consult with their doctor regarding the use of medications and should not stop taking this or any other medication without first talking to their doctor. Stopping use of blood thinning medication puts a patient with irregular heart rhythm at increased risk of stroke.
We provide clear and accurate information to healthcare professionals regarding the benefits and safety profile of Pradaxa through multiple resources, including the Health Canada-approved product monograph. In addition, we provide clear and accurate information to patients including the Health Canada-approved leaflet in each package of Pradaxa.
In the rare event of a major bleed, a number of established measures are available to reverse the blood thinning effect of Pradaxa or to manage bleeding during an emergency situation. These measures are described in the Health Canada-approved product label, and are almost identical for all blood thinning treatments including warfarin and novel oral anticoagulants (NOACs). Pradaxa has the additional option to be removed via dialysis.
There are four statements of claim filed in Canada each naming as plaintiff a single patient on Pradaxa but seeking to represent a broader class of individuals. These cases are all at an early procedural stage; none has been certified by the court which is a necessary step for a class action to proceed.
We are confident the evidence will show we acted appropriately and responsibly in our research, development and marketing of this important medication.
The makers of Pradaxa say: "In the rare event of a major bleed, a number of established measures are available to reverse the blood thinning effect of Pradaxa," including the option to remove the drug with dialysis.
However, some doctors disagree this is an effective method of treatment.
“The idea of using dialysis as a treatment for Pradaxa toxicity is more of a theoretical one,” said Dr. Juurlink.
“I mean typically the patients who need dialyses with Pradaxa are very sick and the whole idea of doing dialyses, it’s not a straightforward suggestion so I don’t think it represents a magical therapy for people who are in hospital bleeding from the drug.”
Other antidotes listed by the company are Prothrombin Complex Concentrates (PCC) -- a combination of blood clotting factors prepared from fresh-frozen human blood plasma -- or a procedure called charcoal filtration. However, there is limited patient data for either method.
And now a new study suggests Pradaxa may work differently in older patients, in women and those with kidney problems, with a five-fold variability in how patients respond with the same dose. Some doctors say this potentially boosts a patient’s risk of serious bleeding.
“We don’t have a way of measuring Pradaxa levels in the blood,” said Dr. David Juurlink, a drug safety expert at Sunnybrook Health Sciences Centre. “You know with warfarin we measured the drug’s effect, we could tell when your blood was too thin or when it wasn’t thin enough and that would sometimes set off alarm bells for the doctor and we would adjust the dose as needed.
“With Pradaxa in particular the degree to which the drug is absorbed varies tremendously from person to person and we have no laboratory way, no easily available way to quantify that.”
And documents released as part of the U.S. lawsuits show that company officials discussed the possibility some patients might need more careful monitoring but that disclosing it to Health Canada and other regulators might “undermine efforts to compete” with other drugs.
