Following surgery, it’s not uncommon for the surgeon to prescribe their various patient medications to assist with the recovery process. One example of this is Pradaxa. It has become a modern form of medication for preventing blood clots from forming in the veins that could become dangerous. Specifically, the drug is for those who have recently undergone total knee or hip replacement surgery. The medicine can also be used to treat blood clots in the lungs or veins of the legs.
Unfortunately, the medication has some potentially dangerous side effects which have been the basis for numerous lawsuits. Some of these have come about because the patient eventually died.
Pradaxa is seen as the heir apparent to another blood thinner, warfarin. For over half a century, warfarin was used to treat dangerous blood clots, but it was also possible that this medication caused strokes too.
When Pradaxa received approval in October of 2010, it was the obvious replacement for warfarin. It had the same core purpose, but also prevented strokes, required less maintenance and was developed to have fewer side effects.
It should come as no surprise, then, that within a year, 16% of people with atrial fibrillation – or an irregular heartbeat – had been prescribed the drug. By 2020, over 3.7 million patients in the United States were taking Pradaxa.
Scrutiny Regarding Pradaxa IUD
However, after only two years on the market, Pradaxa was being accused of costing more than 500 people their lives. In particular, patients and their families reported that the medication was causing hemorrhaging and uncontrollable amounts of bleeding.
In just two years after the initial concerns were raised, the manufacturer behind Pradaxa, Boehringer Ingelheim, had settled more than 4,000 claims for a total of some $650 million. It’s worth noting, though, that as part of these settlements, the company didn’t admit to any wrongdoing on their end. The company even went so far as to point to an FDA study that proved the benefits of Pradaxa and claimed that the positives far outweighed any adverse side effects caused by their drug.
Common Issues Involving the Pradaxa IUD
Any medication that causes thinning of the blood is going to come with two side effects. One is that the patient will automatically bruise easier. The second is that they will suffer from cuts easier too. It’s always important to mention if you’re taking these drugs to your surgeon or dentist, less a serious complication occurs during the procedure.
Pradaxa Side Effects
Pradaxa has been linked to more severe side effects, though. This include:
- Liver failure
- Uncontrollable bleeding
- Heart attack
The uncontrollable bleeding is also related to some other side effects. As it is the most commonly reported one, it’s worth mentioning some of them. They include hemorrhages in the central nervous system and brain, which can be just as bad as a stroke. Obviously, excessive bleeding can also lead directly to death.
Due to the combination of its many side effects and just how many people were taking the drug, Pradaxa has the dubious distinction of being of the most frequently reported drugs in the FDA’s adverse events database for 2011. This is according to the Institute for Safe Medication Practices’ publication, QuarterWatch. During just 2011, it found that 817 separate reports were brought to the FDA’s attention regarding Pradaxa.
The publication then went on to do further research. They found another 3,781 serious adverse incidents reported from health professionals and manufacturers. 542 of these reports involved a fatality.
As we mentioned above, Boehringer Ingelheim came to an overarching settlement back in May 2014 for all outstanding lawsuits in the U.S. regarding complaints about Pradaxa. They did so while pointing to an FDA study that profiles more than 130,000 patients with a positive “benefit-risk profile.”
This doesn’t mean you can’t seek damages if you or a loved one has been harmed by taking this medication. It only speaks to the fact that the manufacturer is well aware of the problem and will already know which legal maneuvering makes the most sense for their needs. Therefore, if you do plan on proceeding with a lawsuit, it’s vital that you hire an experienced attorney – ideally one who has a background representing patients just like you.