Parker Waichman LLP

Europe Regulator Addresses Pradaxa Bleeding Deaths

Europe Regulator Addresses Pradaxa Bleeding Deaths However, the European Medicines Agency (EMA) said that new prescribing recommendations issued last week would mitigate the Pradaxa bleeding risk. Those recommendations advised doctors to subject Pradaxa patients older than 75, as well as those with renal impairment, to annual kidney checks. Pradaxa is excreted through the kidneys, thus […]

Pradaxa Bleeding

Europe Regulator Addresses Pradaxa Bleeding Deaths However, the European Medicines Agency (EMA) said that new prescribing recommendations issued last week would mitigate the Pradaxa bleeding risk.

Those recommendations advised doctors to subject Pradaxa patients older than 75, as well as those with renal impairment, to annual kidney checks. Pradaxa is excreted through the kidneys, thus impaired kidney function could lead to abnormally high levels of the drug in circulation, leading to excessive risk of bleeding.

Boehringer Ingelheim has confirmed 260 reports of fatal bleeding

Boehringer Ingelheim has confirmed 260 reports of fatal bleeding, including 21 in Europe, among Pradaxa patients worldwide, up from the 50 deaths the company confirmed at the start of November. Like all blood thinners,  it carries a risk of bleeding.

In its statement, the EMA maintained that the number of Pradaxa bleeding reports “has to be seen in the context of the rapidly increasing use of Pradaxa worldwide.”

In the past several months, regulators in various countries have pushed Boehringer Ingelheim to increase warnings on Pradaxa recently.

Japan told Boehringer Ingelheim to issue a warning for Pradaxa

In August, for example regulators in Japan told Boehringer Ingelheim to issue a warning for Pradaxa and potentially fatal bleeding after 81 patients taking it there suffered heavy bleeding.

According to a report issued by the Institute for Safe Medication Practices (ISMP), since its October 2010 approval, Pradaxa has been named in more U.S. Food & Drug Administration (FDA) Adverse Event Reports than more than 98% of the medications the group monitors.

Need Legal Help Regarding Pradaxa Bleeding?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations.
For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

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
Nicoleta Mereuta ,answers all my questions and she was polite. She was a pleasure to talk too.
Brenda Simmons
7 months ago
5 Star Reviews 150
I would like to extend my gratitude to both Julie Trinidad and Marianne Gallizzi. They are part of a great team in Parker Waichman. I appreciate the time and effort you took to answer all of my questions.
Karyna Minchala
5 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness Benita, I am so grateful for your passion, professionalism and dedication. I appreciate the amazing legal work you did on my behalf. Thank you so much!
Amelia Hendricks
3 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