Pradaxa, which was marketed as a replacement for another dangerous drug in 2010 is currently under scrutiny for causing bleeding deaths in nearly 600 people in this country. Shockingly, it is still on the market with the blessing of the FDA. Pradaxa was heralded as a replacement for Warfarin, a drug that has been in used for the last 60 years as a blood thinner to treat people with atrail fibrillation and to prevent strokes. However, Pradaxa is reportedly not any safer than warfarin.
While some doctors still deem Pradaxa’s benefits as greater than its risks (that is, your chances of bleeding to death are a smaller worry than a major stroke), there is no antidote. If a patient begins to bleed while on warfarin, the doctors can at least give the patient vitamin K. This does not work with Pradaxa. So, while some doctors say Pradaxa still helps, other doctors say it is “shocking” that the FDA approved it at all. In addition, the doctors who approve Pradaxa are family doctors and cardiologists, not ER doctors who actually have to deal with watching a patient bleed out in their hospital.
Pradaxa is marketed by the private German company Boehringer Ingelheim, and used a tight control group to trial-test the drug. Critics have said this is an example of how drugs that have met expectations, comes face-to-face with “the messy world of real-life medicine.” Still, Boehringer claimed it was working on an antidote, while patients in the clinical trial were dying at the same rate as those taking warfarin.
The company has made over $1 billion in the two years it has been sold.
The FDA reported that Pradaxa did not show a higher rate of bleeding than warfarin, but did not address the fact that there is no antidote. Boehringer says that patients who are bleeding should be treated with dialysis to flush Pradaxa from the body. However, doctors say this is not a realistic option. One said, “People that are bleeding to death aren’t going to tolerate being put on dialysis.”
There are other drugs to replace warfarin that also lack antidotes. These are Xarelto, sold by Bayer and Johnson & Johnson that was approved in 2011, and Eliquis by Bristol-Myers Squibb and Pfizer, which has not yet been approved.
If you or a loved one has been seriously injured by a defective drug, please contact an experienced personal injury attorney in your area today.