Saturday, June 16, 2012

Pradaxa Litigation: The Research Studies and Safety of the Drug

The RE-LY Study

Continuing from Part One of the Pradaxa Lawsuit articles, we continue with the discussion held by attorneys who are interested in Pradaxa litigation and the issues they found to be of primary importance. Discussed at length was the RE-LY study Boehringer Ingelheim used in order to receive FDA approval. RE-LY stands for Randomized Evaluation of Long Term Anticoagulation Therapy and was aimed at evaluating the efficacy and safety of Pradaxa capsules in 18,000 sufferers of atrial fibrillation. Study results showed that 182 Pradaxa users who were taking the 110 mg. dosage of suffered a stroke while 134 patients taking the 150 mg. dosage suffered a stroke.

Heart Attacks in Pradaxa Users

Both groups of Pradaxa users experienced higher rates of heart attacks than those on Warfarin. The safety concerns noted as a result of the RE-LY study were excess dyspepsia, heart attack, a higher accumulation of the drug in those with kidney or liver dysfunction and a higher rate of major GI bleeds. Based on this single study, Boehringer claimed their drug offered a 35% reduction of stroke when compared with Warfarin, however they neglected to mention that there was also as much as a 50% increase in GI bleeds.

In other words, the drug is more effective yet also more dangerous. The Australian government believed the efficacy outweighed the risks however more and more scientists and physicians are now questioning those efficacy claims. There are numerous reasons to believe that Warfarin is, in fact, overall the better drug for most patients. One attorney at the seminar noted that it was his belief the Pradaxa litigation would live or die based on the RE-LY study.

Is the RE-LY Study Flawed?

The belief of many is that the RE-LY study, in addition to being only one study, suffered under inherent flaws. It is difficult to understand how the drug was approved based on a single study which overall does not equate to a real-life setting. The data and integrity of the study have been called into question, and before the FDA would approve Pradaxa based on the RE-LY study they required that it be re-analyzed twice. Further, eighteen out of the twenty authors of the RE-LY publication were found to have financial conflicts regarding the study, meaning they were paid by Boehringer Ingelheim.

There is a huge difference between independent studies and studies which are funded by the company manufacturing the drug. The RE-LY study was neither a double-blind study nor was it placebo-designed which again raises serious questions about the reliability of the study. It is further believed that the manufacturers of Pradaxa targeted a much broader population than was appropriate, therefore the risk of adverse events was also much higher. Further, the 75 mg. dosage, although often prescribed, was not even a part of the RE-LY study which studied only 110 mg. and 150 mg. The third installment of the Pradaxa Litigation articles will discuss venue and the inadequacies of the Pradaxa labeling.

Author: Sullo & Sullo Attorneys

0 Comments

Categories: ImportedNumber of views: 1499

Tags: Heart Attacks pradaxa lawsuit Pradaxa Litigation

Please login or register to post comments.

250,000 CLIENTS REPRESENTED

FREE CASE REVIEW

Full Name* Email* Telephone Number* Are You already a Client?* Type of Case* Tell Us About Your Case*

WARNING: Do not send any information in any email through this website if you consider the information confidential or privileged.

I understand that by submitting my contact information to Sullo & Sullo LLP for review, I consent to messages regarding this legal matter as well as marketing for other potential legal matters in the future without limitation at standard messaging and data rates unless terminated by me in writing. I further understand that my submission of any and all information in response to this website does NOT create a lawyer-client relationship between myself and Sullo & Sullo, LLP and/or its lawyers, and that any and all information submitted is NOT confidential or privileged. I further acknowledge that, unless Sullo & Sullo, LLP subsequently enters into an Attorney-Client relationship with me, any and all information I provide will NOT be treated as confidential or privileged, and any such information may be used against me and/or for the benefit of current or future clients of Sullo & Sullo, LLP. ...READ ENTIRE DISCLAIMER

Receive an Immediate Response

ANDREW SULLO IS A TOP 100 NATIONAL TRIAL LAWYER 2013 • 2014 • 2015 • 2016 • 2017 • 2018 • 2019

Obtener una Respuesta Inmediata

Andrew Sullo – 100 Mejores Abogados Nacional | 2013 • 2014 • 2015 • 2016 • 2017