Parker Waichman LLP

Is Pradaxa Worth the Risks?

Pradaxa, a new type of blood thinner approved by U.S. regulators in October 2011, may not be living up to its promise. According to a report from The Cleveland Plain Dealer, at least one study published this year has linked Pradaxa to a higher risk of heart attacks. Meanwhile, concerns are mounting about Pradaxa’s bleeding […]

Pradaxa, a new type of blood thinner approved by U.S. regulators in October 2011, may not be living up to its promise. According to a report from The Cleveland Plain Dealer, at least one study published this year has linked Pradaxa to a higher risk of heart attacks. Meanwhile, concerns are mounting about Pradaxa’s bleeding side effects, which are often irreversible.

Pradaxa is used to prevent strokes in people with atrial fibrillation. It was expected to be adopted as a replacement for warfarin, which can have dangerous interactions with certain foods. According to the Plain Dealer, warfarin also requires frequent blood tests to monitor how well the blood is clotting.

Pradaxa was approved by the U.S. Food & Drug Administration (FDA) based on the results of the RE-LY trial, which showed it was effective in preventing strokes, but also hinted at a possible risk of heart attacks linked to Pradaxa, according to The Plain Dealer. In January, a study published in the Archives of Internal Medicine, which pooled data for six smaller trials, found that patients in the Pradaxa groups had a 33 percent increased chance of having a heart attack. Overall, there were 237 coronary events among the 20,000 combined trial participants taking Pradaxa compared with 83 of 10,514 taking warfarin, the Plain Dealer said.

Another problem with Pradaxa is bleeding, a common side effect of all blood thinners, including warfarin. Warfarin bleeding can be stopped with the administration of vitamin K, but there is no similar antidote or Pradaxa bleeding. Earlier this month, a study in the Journal of Neurosurgery highlighted this risk, detailing the worsening condition, and ultimate death, of an 83-year-old Pradaxa patient following a minor fall. Within two hours of his arrival at the hospital, scans showed extensive progression of brain hemorrhaging. His doctors administered intravenous fluids and a protein called recombinant factor VIIa to stop the bleed, but nothing worked. The man fell into a deep coma, and died shortly after.

That incident was just latest report to raise concerns about Pradaxa bleeding side effects. Last year, Boehringer Ingelheim acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa. The FDA launched a review of Pradaxa in December over reports of bleeding-related side effects, while regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa.

“What we’ve seen is that the amount of people having death from hemorrhagic events in the brain is higher than expected,” epidemiologist Adrian Hernandez told the Plain Dealer. “That’s another part that’s being played out now as part of this risk-benefit.”

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I want to give a heartfelt thank you to Ms. Benita Rollis for the exemplary manner in which my case was handled from the inception to the end. Ms. Rollis was compassionate, friendly, understanding, professional, accurate, informative and patient. She took the time and effort to explain the process, timeline, the various documents involved and how to go about obtaining certain forms. She was definitely on point. If I had to go this route again, I would hands down, choose and highly recommend Ms. Rollis because she is highly competent in getting the job done. She is a definite asset to Parker Waichman LLP. On behalf of myself and my family we thank you for a job well done. Be well and be blessed. Margarita R. Mitchell
Margarita Mitchell
3 years ago
5 Star Reviews 150
Thank you Parker Waichman for helping me with my case. You know what you are doing. They are very professional, I would say they are the best. Thanks to Jorge Peniche for helping me feel that I need it.
anyelo robles
4 years ago
5 Star Reviews 150
This law firm is awesome. Alex and Cathy did there thing. As long as I been with them I still don't know Cathy's name. They were NEVER to busy. The young ladies in the front lobby very nice. When they would see me they knew my name. That's how I knew I had the right law firm. Thank you for easing my mind.
yolanda keitt
a year ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038