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LATEST PRADAXA UPDATES

Here's what's happening in 2017 with Pradaxa...

PRADAXA News & Updates Timeline

The blood-thinning drug Pradaxa was released in 2010 as the first of a new class of novel oral anticoagulants (NOADS). Meant to prevent blood clots and strokes in patients with atrial fibrillation, it was claimed to be safer than traditional medications Coumadin and warfarin, while not requiring patients to undergo regular blood testing or change their diet.

Pradaxa quickly grew in popularity to over $1 billion in annual sales, but has struggled in recent years with the release of competitors Xarelto and Eliquis. Also, recent expert warnings of untold internal bleeding dangers and injury lawsuits from thousands of patients have clouded its success in recent years.

4,000 patient lawsuits for around $650 million, and the company now faces additional litigation form those affected since.

Consumer safety groups tracking FDA adverse event reports have consistently ranked Pradaxa among the most dangerous medications, as thousands have reported internal bleeding injury or death.

In May of 2014, Boehringer Ingelheim resolved more than 4,000 patient lawsuits for around $650 million, and the company now faces additional litigation form those affected since.

2016

Timeline
25
NOV 2016

Boehringer Ingelheim faces over 3,000 new lawsuits in Connecticut, Missouri and California over internal bleeding allegedly caused by Pradaxa.

3
OCT 2016

Study in JAMA finds Pradaxa users had lower internal bleeding and death rates than those taking Xarelto.

23
JUL 2016

New $6.5 million study announced to compare the safety of Pradaxa, Eliquis, Xarelto and Coumadin at the University of California at San Francisco and Brigham and Womens' Hospital in Boston.

29
JUN 2016

ISMP report estimates the FDA received 16,222 complaints of internal bleeding for new-generation blood thinners like Pradaxa last year.

24
MAY 2016

Study published in BMJ finds internal bleeding risks of Pradaxa disclosed in clinical trials was underestimated by as much as 66%.

2015

Timeline
23
Nov 2015

FDA approves Pradaxa for the prevention of blood clots in patients who’ve undergone hip replacement surgery.

19
OCT 2015

FDA Adverse Event Reporting System database shows 973 reports of patient death related to Pradaxa and 9,000 hospitalized for internal bleeding.

16
OCT 2015

FDA approves Praxbind, an antidote from Boehringer Ingelheim designed to stop the blood thinning effects of Pradaxa in cases of emergency internal bleeding.

23
SEP 2015

Institute for Safe Medication Practices ranks Pradaxa behind Eliquis and Xarelto in patient safety profile due to bleeding reports.

MAY 2015

Lawyers announce a second round of litigation for Pradaxa bleeding victims not included in the May 2014 settlement.

07
JAN 2015

ProPublica reports Pradaxa maker Boehringer Ingelheim paid $4.43 million to doctors in 2014 for promotion of drug.

2014

Timeline
17
DEC 2014

Researchers at UCLA release study showing new blood thinners like Pradaxa may be less likely to cause intracranial bleeding than warfarin.

DEC 2014

Researchers from Israel's Hematology and Blood Bank Institute at Tel Aviv University find risks of gastrointestinal internal bleeding higher with Pradaxa than warfarin.

28
MAY 2014

Boehringer Ingelheim announces it will pay $650 million to settle over 3,500 lawsuits alleging internal bleeding injury or death from Pradaxa.

26
FEB 2014

Bloomberg reports records filed in Pradaxa litigation suggest Boehringer Ingelheim may have withheld data from the FDA showing higher-than-expected internal bleeding side effects.

FEB 2014

Judge David Herndon orders court records unsealed which show Boehringer Ingelheim executives sought to conceal internal studies suggesting Pradaxa bleeding risks are higher if drug is used without blood tests as marketed.

2013

Timeline
30
DEC 2013

FDA announces new Mini-Sentinel study to re-assess the bleeding risks of Pradaxa.

09
DEC 2013

U.S. District Judge David Herndon fines Boehringer Ingelheim $931,000 for withholding or failing to preserve “countless” documents in Pradaxa litigation.

OCT 2013

The Institute for Safe Medication Practices ranks Pradaxa highest among all prescription drugs for the number of annual adverse events reported to FDA, with 683 reports of bleeding.

AUG 2013

Boehringer Ingelheim publishes data on its German website admitting the company has received notice of 8,976 internal bleeding episodes and 1,435 deaths among patients, but does not disclose the data in the United States.

JUL 2013

Dutch study indicates patients taking newer blood thinners like Pradaxa could have a 55% higher risk of internal bleeding.

MAR 2013

Study from the University of Illinois at Chicago finds Pradaxa internal bleeding risks may be more dangerous than warfarin.

09
JAN 2013

Study from the University of Illinois at Chicago finds Pradaxa internal bleeding risks may be more dangerous than warfarin.

2012

Timeline
08
AUG 2012

The Judicial Panel on Multidistrict Litigation orders Pradaxa lawsuits consolidated to Federal MDL Court 2385 in the Southern District of Illinois under the supervision of Judge David Herndon.

25
JUL 2012

U.S. District Judge David Herndon denies attempts by Boehringer Ingelheim to dismiss Pradaxa lawsuits filed by bleeding victims.

2010

Timeline
19
OCT 2012

The FDA approves Pradaxa for the prevention of blood clots and stroke in patients with atrial fibrillation.