Parker Waichman LLP

FDA: Blood Thinner, Pradaxa, Should Not Be Used by Patients with Mechanical Prosthetic Heart Valves

Blood thinner, Pradaxa (dabigatran etexilate mesylate), should not be used to prevent stroke or blood clots in patients implanted with mechanical heart valves. The U.S. Food and Drug Administration (FDA) has recently informed health care professionals and the public of the dangers of Pradaxa for patients with mechanical heart valves. A clinical trial in Europe […]

pradza heart valve riskBlood thinner, Pradaxa (dabigatran etexilate mesylate), should not be used to prevent stroke or blood clots in patients implanted with mechanical heart valves.

The U.S. Food and Drug Administration (FDA) has recently informed health care professionals and the public of the dangers of Pradaxa for patients with mechanical heart valves. A clinical trial in Europe was halted because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the heart devices than were users of warfarin, another anticoagulant medication. Pradaxa users also experienced more bleeding after valve surgery than those taking warfarin.

Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), a common heart rhythm abnormality. The drug, however, is not approved for patients with atrial fibrillation caused by heart valve problems.

The FDA recommends that health care professionals transition any patient with a mechanical heart valve who is taking Pradaxa to another medication. Note: the use of Pradaxa in patients with valve replacements made of natural biological tissue has not been evaluated.

The FDA warns that patients should not stop taking anticoagulant medication without consulting their health care professionals. Suddenly stopping Pradaxa or other anticoagulants may increase the risk of blood clots and stroke.

Patients and health care professionals are encouraged to report adverse events or side effects related to Pradaxa use to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Reports can be submitted online: www.fda.gov/MedWatch/report.htm. Download the report form at this site or call, toll-free, 1.800.332.1088 to request a copy of the pre-addressed form, which may be mailed to FDA or submitted by fax to 1.800.FDA.0178.

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
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
5 Star Reviews 150
I am a 9/11 survivor and it was my good fortune to work with paralegal Benita Rollis. She thoroughly explained the process and helped me to complete all the paperwork. I distinctly remember the day she called to check on me and to encourage me to schedule a medical appointment with WTC health program. I was reluctant to proceed but Benita gave me a much needed pep talk. Thank you Benita! All of Benita’s hard work has made the difference and this has been concluded very favorably.
FredHart
2 years ago
5 Star Reviews 150
Always there for you
oskeeno 45
2 years 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