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Investigation: Pradaxa most complained about U.S. drug; blamed for deaths, life-threatening injuriesCLEVELAND - A Five On Your Side Investigation found Pradaxa, a popular blood thinner, is the most complained about drug in the United States.Our research found more complaints were filed with the FDA about Pradaxa than any other prescription drug in both 2011 and 2012.Since it was approved by the FDA in 2010, Pradaxa has been blamed for 1,158 U.S. deaths and 12,494 serious injuries, according to Tom Moore, the senior scientist for drug safety and policy at the Institute for Safe Medication Practices. The ISMP is a...
Source: PharmaGossip - February 19, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
"Can't This be Avoided?" - How Corporate Marketers Manipulated a Clinical Research Report to Avoid "Undermining" Marketing Messages
ConclusionsThis case study, only made possible by the public release of internal corporate documents in the course of litigation, suggests that in retrospect the dissemination of the results of one particular clinical trial were manipulated in a somewhat subtle way so that the data would not contradict a marketing message that now appears rather fictional.In the absence of litigation, and of a judge willing to make public documents that one party to the litigation doubtless wanted to hide, the manipulation of this particular study might never have been apparent. Most clinical research is now sponsored by health care ...
Source: Health Care Renewal - February 13, 2014 Category: Health Medicine and Bioethics Commentators Tags: Boehringer Ingelheim deception manipulating clinical research Pradaxa secrecy Source Type: blogs
Clot Wars contd. - More than 2,000 Lawsuits Over Pradaxa Bleeding Risks, Boehringer Confirms
Boehringer Ingelheim, manufacturer of the blood-thinner Pradaxa (dabigatran), has confirmed that it faces more 2,000 lawsuits in the United States alleging that the drug causes severe and fatal bleeding.The company’s confirmation came after the German newspaper Handelsblatt reported the number. Boehringer said that the company has to weigh the risk of known side effects against the drug’s life saving potential, according to Reuters. “We are certain that we can show in the legal cases that we have worked very carefully and responsibly in research, development and marketing of Pradaxa,” the German drug maker said in ...
Source: PharmaGossip - February 13, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Boehringer Ingelheim's High Ranking in Social Media Patient Engagement vs. Shameful Real Life Anti-Patient Behavior
(Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - February 9, 2014 Category: Pharma Commentators Tags: Boehringer Ingelheim Drug Safety Pradaxa social media Twitter Source Type: blogs
Popular Blood-thinner Manufacturer Didn’t Want Internal Research Made Public
Boehringer Ingelheim, the manufacturer of the blood-thinning drug Pradaxa, was concerned that releasing the results of an internal research paper on the drug would damage drug sales, records recently made public show. The company was so worried about the results of the study that some employees pressured the author to revise it, and the company recommended it be thrown out, according to a recent report by the New York Times.Records recently made public by a federal judge in Illinois presiding over thousands of lawsuits against the maker of Pradaxa, including emails, internal memos, and presentations, centered on the resear...
Source: Medical Hemostat - February 7, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
DTC Melee–a-Trois: Pradaxa, Xarelto, and Eliquis. Women Only Marginally Involved.
(Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - January 24, 2014 Category: Pharma Commentators Tags: AFib BMS Boehringer Ingelheim DTC Advertising Eliquis Janssen Pradaxa warfarin Xarelto Source Type: blogs
FDA Plans New Safety Assessment Of Dabigatran (Pradaxa)
Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the US in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin. n December 30 the FDA posted a request for public comment on a proposed protocol of the study, which it describes as “a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin.” … Click here to read the full post on Forbes. (Source: CardioBrief)
Source: CardioBrief - January 3, 2014 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms People, Places & Events Prevention, Epidemiology & Outcomes anticoagulants dabigatran FDA warfarin Source Type: blogs
New post up at Medscape Cardiology: Are novel anticoagulants better than warfarin?
For the prevention of stroke in atrial fibrillation, the novel anticoagulant drugs dabigatran (Pradaxa, Boehringer Ingelheim), rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals), apixaban (Eliquis, Pfizer/Bristol-Myers Squibb), and edoxaban (Lixiana, Daiichi-Sankyo) have been sold as both superior and more convenient than warfarin.
But is this true? More than 60,000 patients have been enrolled in randomized controlled clinical trials. Recently, two meta-analyses (studies that combine trials) have been published. That’s a bunch of data.
I had originally set out to explain how these meta-analyses had once and ...
Source: Dr John M - December 20, 2013 Category: Cardiology Authors: Dr John Source Type: blogs
New Trial Confirms Role For Pradaxa In Venous Thromboembolism
A new study helps support a role for the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE). The RE-COVER II trial, published online in Circulation, confirms the finding of the earlier and highly similar RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and effective as warfarin for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Dabigatran is currently approved only for the treatment of stroke prevention in patients with non-valvular atrial fibrillation. In RE-COVER II 2,589 pati...
Source: CardioBrief - December 18, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms People, Places & Events Prevention, Epidemiology & Outcomes apixaban boehringer ingelheim dabigatran deep vein thrombosis rivaroxaban VTE Source Type: blogs
A Second Order Cover Up? - Judge Finds Boehringer Ingelheim Allowed Destruction of Records Bearing on Allegations of Cover Up of Drug Adverse Effects
This case generated little coverage, a story in Bloomberg, and a post on PharmaLot, but perhaps should have received more attention.Background - the Pradaxa Case The background, per Bloomberg, is thatBoehringer [Ingelheim BmbH] is preparing to face the first federal court trial of claims that it hid Pradaxa’s bleeding risks. Pradaxa is dabigatran, a new anti-coagulant drug that can be used without frequent monitoring of blood tests, as is required when using the older drug warfarin. However, unlike warfarin, the effects of dabigatran cannot be quickly reversed should a patient on the drug start to bleed. The r...
Source: Health Care Renewal - December 16, 2013 Category: Health Medicine and Bioethics Commentators Tags: Boehringer Ingelheim deception Pradaxa warfarin Source Type: blogs
Are doctors being duped through medical education? Could social media help?
I made a discovery this week about the novel anticoagulant medications, dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis) and edoxaban (Lixiana). I was looking into the often-asked question of how these new drugs compare to the old standard, warfarin.
The discovery felt like a Eureka moment. I ran it by my stats guy–my son–and a couple of colleagues, and they confirmed, that my discovery was truth. I’m working on a post now that discusses the details of how the medical world has been misled about these drugs. Stay tuned.
Medical Education:
For now, though, this revelation got me thinking abo...
Source: Dr John M - December 14, 2013 Category: Cardiology Authors: Dr John Source Type: blogs
Boehringer's "gross inadequacy"
Boehringer Fined $931,000 Over Lost Pradaxa FilesBoehringer Ingelheim GmbH, which markets and manufactures Pradaxa, has been charged with a nearly $1 million fine, according to a recent ruling. The fine was levied for the drug maker’s withholding or failing to preserve files sought in Pradaxa litigation, according to the judge’s ruling.The “countless” files were sought by patients who have brought lawsuits over the blood thinner, Pradaxa, Bloomberg News reports. U.S. District Judge David Herndon, located in East St. Louis, Illinois, is overseeing more than 1,700 consolidated lawsuits that have been f...
Source: PharmaGossip - December 13, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Boehringer Is Fined Nearly $1M For Disappearing Documents
How much does it cost if potentially damaging documents disappear? How about $931,000? This is what Boehringer Ingelheim must pay in fines after a US federal court judge expressed dismay and outrage that the drugmaker failed to preserve “countless” files sought by patients who filed lawsuits claiming the Pradaxa bloodthinner caused excessive and, sometimes, fatal bleeding.
In a ruling this week, US District Judge David Herndon, who is overseeing more than 1,700 lawsuits, found that Boehringer executives acted “in bad faith” by failing to ensure that documents and files about Pradaxa development and marketing were p...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Large Study Finds Favorable Risk-Benefit Profile For The New Anticoagulants
A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of the new agents. Although warfarin is inexpensive, it has numerous interactions with other drugs and foods and requires regular monitoring and dose adjustments. The new agents can be taken once or twice a day and do not require dose changes. More… (Source: CardioBrief)
Source: CardioBrief - December 5, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms Policy & Ethics Prevention, Epidemiology & Outcomes Anticoagulant anticoagulants apixaban atrial fibrillation boehringer ingelheim dabigatran Daiichi Sankyo Pfizer rivaroxaban stroke Source Type: blogs
