Pradaxa® may just be the country’s next blockbuster civil settlement, according to some legal professionals. This statement appears to have some truth behind it as the number of Pradaxa® lawsuits continues to rise.
At the end of last month, the multi-district litigation over Pradaxa® had reached 78 cases; and already, the number has grown to top 100.
This is just the tip of the iceberg. According to USA Today, the FDA received 3,781 reports of adverse effects and 542 reports of death in patients taking Pradaxa® last year alone. This, according to USA Today, tops all other monitored drugs.
The popular blood thinner, which is prescribed to prevent strokes in patients with atrial fibrillation, has been prescribed to millions of patients. The lawsuits claim that the drug has caused serious side effects, including severe internal bleeding events.
While it is no secret that anticoagulant drugs increase the risk of internal bleeding, the problem with Pradaxa® is that there is no way to reverse the internal bleeding once it starts.
When Pradaxa® first hit the market in 2010, it seemed as though it was an easier, safer alternative to warfarin, sold under the brand name Coumadin. Warfarin, the oldest stroke prevention medication on the market, requires patients to receive weekly exams and to follow strict diets. It also is linked to an increase in the risk for brain hemorrhage and other types of internal bleeding.
So, when Boehringer Ingelheim introduced Pradaxa® as an alternative that didn’t call for selective eating and required fewer doctor appointments, members of the health care community celebrated. But, did they celebrate too early?
Boehringer Ingelheim, one of the largest pharmaceutical companies in the world, jumped on the opportunity and began marketing Pradaxa® as a shiny new penny. Everyone else ate it up. In 2011, according to USA Today, the company’s $464 million marketing efforts worked; sales of Pradaxa® that same year topped $1 billion.
But, what everyone didn’t realize is the new medication brings serious risks. Now, many people are arguing that the drug was released to the market too early, with inadequate testing.