Pradaxa Side Effects: Internal Bleeding, Stroke & Death
Pradaxa, a blood thinner, has only been on the market since 2010. However, Pradaxa side effects of internal bleeding, strokes and over 250 deaths have already been reported. Here's more information about Pradaxa, Pradaxa side effects and why this drug - also known as Dabigatran - is so controversial.
What Is Pradaxa and How Does it Work?
Pradaxa is a blood thinner or anti-coagulant called a direct thrombin inhibitor. According to Pradaxa injury lawyers, it is a substitute for Coumadin (Warfarin) therapy used by patients who are at risk of stroke - either as a result of atrial fibrillation or post surgical complications. Pradaxa was developed by Boehringer Ingelheim, whose headquarters are in Connecticut.
Dabigatran does not work on the same pathways like Coumadin, specifically that it doesn't affect the Vitamin K pathway. It was thought to be more advantageous than Coumadin because patients who take the drug have to be careful about what they eat after having hip or knee replacement surgery, atrial fibrillation or other complications.
These patients have to avoid certain green leafy vegetables which would affect Vitamin K metabolism and those pathways. Pradaxa is different. It works on thrombin, which is another part of the clotting cascade in the clotting agency that works to prevent clots. However, the drug has now been linked to internal bleeding, stroke, heart attacks and more - and has resulted in death for more than 250 people.
Pradaxa Internal Bleeding / Pradaxa Hemorrhaging
Shortly after Pradaxa was approved in October 2010, instances of significant bleeding / hemorrhaging were being reported by patients who were being switched from Coumadin to Pradaxa - many of whom later required hospitalization.
In November 2011, only 13 months after the drug was approved and in response to the numerous FDA inquiries and adverse event reports, Boehringer reported that its labeling was going to be changed and that doctors were going to be warned that they needed to be on the lookout for these types of internal bleeding risks.
Specifically, the company warned doctors that they needed to conduct baseline renal tests as Pradaxa is metabolized through the kidneys - and very quickly - sometimes it achieves the maximum or optimum levels in the blood (known as C-max) with the first pill.
However, this "warning" was extremely light, almost non-decipherable and many say much too long in coming - especially the families of the 260 patients who may have died after taking the drug. As a result, Dabigatran litigation is likely to increase significantly in 2012.
Determining Whether You've Suffered from Pradaxa Side Effects
According to Pradaxa injury attorneys, Pradaxa side effects would be fairly apparent to most people. These side effects would cause a patient to suffer an adverse event at home such as a hemorrhagic stroke, brain bleed, severe internal bleeding or seeing blood in the stool. Most likely, the patient would also experience significant weakness and become so sick that their going to end up in the hospital.
Other reports of Dabigatran side effects include internal bleeding, excessive bleeding, bleeding from the gums, nose bleeds that won't stop, coughing up blood, blood in the lungs, blood in the gastrointestinal system, vomiting which looks like coffee grounds, severe bruising and excessive bleeding for women who are menstruating.
These serious Pradaxa side effects have left doctors, patients, consumer advocates and the FDA to ask...
Wasn't Pradaxa Supposed To Be Better Than Coumadin?
That's what most people thought, but the side effects listed above seem to tell another story. According to Pradaxa injury lawyers, when the drug came on the market, the hope was that it would carry less side effects than Coumadin - a drug that has been around for nearly 100 years - but carries a lot of baggage. Patients on Coumadin require regular monitoring on a monthly, weekly or even daily basis to keep that INR (the clotting factor measured through blood tests) at a certain level to avoid a clot. That monitoring can be a real issue for some patients.
In addition, Coumadin has always had a bit of a stigma attached to it. Warfarin, the brand name for Coumadin, actually has the same active ingredient as rat poisoning. So, any drug company who could come out with a drug that didn't require monitoring and didn't have that stigma would likely do well. There's been speculation that the U.S. Food & Drug Administration (FDA) was looking for a pharmaceutical company to create such a drug and that Boehringer knew that.
Other drug companies such as Pfizer knew it as well and likely realized the potential for a huge profit margin and market share. Insurance companies also liked the idea of a Coumadin like drug that didn't require monitoring as it costs them money - especially paying for doctors' time.
Clinical Trials Demonstrated Benefit, But...
Drug companies seeking to please doctors, insurance companies and investors by gaining a share of this market started engaging in clinical trials just to prove that this drug was equal to Coumadin. It didn't have to be better, just similar and less of a hassle.
Boehringer's clinical trial date demonstrated an actual benefit at a lower dose - 75 milligrams - with a 20 percent reduced risk of stroke in patients who were given Pradaxa. There was a 40 percent reduced risk of stroke in patients who were given 150 milligrams.
The company was able to point to that in their marketing and doctors were very excited as there is a definite risk of stroke in these patients that either have a-fib or that have undergone hip or knee replacement surgery. However, doctors don't seem to have received information about reported problems as quickly.
Dabigatran Injury PDR
According to Dabigatran lawyers, the only information that doctors were getting with respect to the use of this drug was coming from Boehringer's sales representatives and the company itself. However, the most current Dabigatran injury PDR (Physicians Desk Reference) - which was just released - says that patients with a creatinine clearance of greater than 30 milliliters a minute (which is considered a normal level and better than normal level if you have a creatinine clearance greater than 30), the recommended dose is 150 milligrams twice daily. However, if your creatinine clearance is in that 15 to 30 range, which is in the normal to borderline normal range, they only recommend the 75 milligram dose. If your creatinine clearance is less than 15, they make no recommendation at all.
It is expected that the new labeling will reference the contraindication in those patients as opposed to a failure to recommend a dose for those patients. However, if that bleeding event can be tied to a change in renal function, it's almost a certainty that patients would go back on Coumadin.
If you've suffered a Dabigatran (Pradaxa) injury, contact a Dabigatran injury lawyer to discuss your situation and determine whether you might be entitled to compensation. You may be entitled to damages such as medical bills, lost wages, emotional distress and more. However, don't delay as every state has its own statute of limitations (time limit) as to when a Dabigatran lawsuit must be filed.