Pradaxa Lawsuits: 260 Deaths Already Reported
There have been 260 deaths associated with the blood thinner drug Pradaxa (Dabigatran) and numerous Pradaxa lawsuits have been filed against Boehringer Ingelheim that include Pradaxa internal bleeding lawsuits, Pradaxa stroke lawsuits, Pradaxa heart attack lawsuits and more. Here's more information on each:
- Pradaxa Internal Bleeding Lawsuits
Pradaxa injury lawyers say that Pradaxa may carry a greater risk of internal bleeding than appears on the drug's warning label. In fact, over 300 adverse events were reported to the U.S. Food & Drug Administration (FDA) in the first three months that Pradaxa was on the market -- mostly due to internal bleeding issues. After only 13 months on the market, Boehringer reported that 260 deaths had been associated with Pradaxa and internal bleeding problems.
Pradaxa internal bleeding lawsuits allege that the initial clinical trials used to gain approval for the drug were flawed, biased and that Boehringer did not adequately research possible Pradaxa side effects or warn patients about the potentially life threatening consequences of taking Pradaxa instead of Coumadin.
Pradaxa Stroke Lawsuits
There were also reports of hemorrhagic strokes, which is the opposite kind of stroke the drug was meant to prevent. Pradaxa was meant to prevent an ischemic stroke, or a stroke caused by clot. However, there have now been reports of hemorrhagic strokes - caused by bleeding in the brain - which have resulted in death. These have led to numerous Pradaxa stroke lawsuits being filed against Boehringer - and more are likely to be filed in 2012.
Pradaxa Heart Attack Lawsuits
Heart attacks were another Pradaxa side effect reported by initial clinical trials at the Cleveland Clinic - although that risk was relatively low. However, a group of scientists decided to go back through the clinical trial data for Pradaxa and look at the adverse event reporting - and they found a mistake. They found a mistake in the way that Boehringer was counting heart attacks when doing what's called a mata analysis. Boehringer included the data from each of the clinical trials and combined it into one. However, looking at the data individually, scientists found that there was actually a 33 percent increased risk of heart attacks for patients taking Pradaxa. As a result, Boehringer is likely to face numerous Pradaxa heart attack lawsuits as well.
Pradaxa Internal Bleeding Risks Similar To Birth Control Litigation
Regardless of the specific type of injury reported, Pradaxa lawyers say that internal bleeding is what these injuries have in common. They point to birth control litigation as a classic example of how Pradaxa levels in the blood stream can cause problems and say that when you take a birth control pill every day, your levels of estrogen and progestin shoot up and then they come back down. The same thing happens when you take one the next morning - they shoot up and they come back down.
It's that curve which is the issue because even though you have a high level of it when you first take the pill, they come all the way down and then go back up. So, the amount of time in which you have a C-max dose of the drug in your blood is lower when you take the drug that way.
When they started using the birth control patch, the Ortho Evra patch, that changed it because it was a constant dose that kept that C-max level constant throughout the entire time you were on the patch. However, that leads to an increase in adverse events.
Pradaxa works the same way. It achieves C-max quickly, and because of the twice daily dosing, you maintain at that C-max level. That's where the kidneys come in. A person's kidney function begins to decrease as they age and many patients who take this drug are older, have medical issues or have recently undergone surgical procedures.
When a patient's kidneys begin to decrease in function, all of a sudden that C-max level, the amount of Pradaxa that's available in the blood, can increase not just by the percentage of what the decrease in kidney function is, but almost exponentially.
For example, a 10 percent decrease in kidney function might result in a 10 percent increase in Pradaxa, but then a 20 percent decrease in kidney function might result in a 40 percent increase in the available drug in the blood. That's when you have these bleeding problems which have been reported and the subsequent label changes to the drug.
Patients taking this drug have no reason to suspect having a kidney problem and are not being checked by their doctor every week or even every month. However, in some cases, patients' creatinine clearances have suddenly dropped from somewhere in the 40 range to the 25 range and they find themselves in the hospital. Unfortunately, there is no antidote to Pradaxa as there is with Coumadin to stop bleeding. The only real treatment is likely to be transfusions to introduce more blood.
More Dabigatran Injury Lawsuits Likely
Pradaxa lawyers say that scrutiny for the drug will likely get a lot tougher - and result in more Dabigatran lawsuits in the very near future. In fact, some of the post marketing studies seem to indicate that the original clinical trials excluded patients who had significant kidney problems. However, they say that that simply doesn't match with what happens in the real world where patients dodevelop kidney problems - and without regular monitoring, that can happen without a doctor's knowledge.
It was this lack of required monitoring that made Pradaxa an attractive alternative to Coumadin. However, now it seems as though medical monitoring is required - making many wonder whether the drug would have ever been approved in the first place if the company had simply disclosed that information.