Friday, November 1, 2013

Pradaxa Fraud

Pradaxa Fraud


Warfarin has been an effective Pradaxablood-thinning product for nearly 60 years. Like any blood thinner, it can work too well and cause uncontrolled bleeding; but there is an anecdote to stop the bleeding from Warfarin. Such is not the case with Pradaxa.
Touted by Boehringer Ingelheim Pharmaceuticals  as a new generation of Warfarin, Pradaxa is a disaster. Unlike Warfarin, there is no anecdote to stop the bleeding of someone taking Pradaxa; a patient can consequently bleed to death. Pradaxa’s creator rushed it to market without properly studying it for safety. The research behind Pradaxa shows little to no substantive proof that it works as well or any better than Warfarin, or any definitive proof that it is even safe, whether its benefits can be said to outweigh its serious risks. Pradaxa is a fraud perpetrated on the public.
Boehringer Ingelheim Pharmaceuticals sells Pradaxa (dabigatran etexilate mesylate) to reduce the likelihood of stroke in atrial fibrillation patients, or those with  irregular heart rhythm.
An anticoagulant, Pradaxa works by blocking an enzyme in the blood necessary for clotting. Blood clots can lead to strokes.
Lawsuits filed against Boehringer Ingehleim Pharmaceuticals charge that the company misrepresented Pradaxa as safe and effective, though they were aware, and several studies later proved, that no antidote exists to undo the drug’s penchant for causing uncontrolled bleeding.
Lawsuits also charge that Pradaxa’s maker negligently failed to use due care in developing Pradaxa, failed to provide Pradaxa users with adequate warnings,  failed to give actual rates of irreversible bleeds associated with Pradaxa, failed to conduct adequate trials, released misleading information regarding Pradaxa.
Suits also claim that Pradaxa’s makers concealed knowledge that Pradaxa can cause life-threatening, irreversible bleeds, hence failing to warn plaintiffs, their decedents, the general public and the medical community of Pradaxa’s real dangers.
Some facts and observations regarding Pradaxa:
a. There is no research for the safety of Pradaxa and no good-faith attempt to instruct users in how to stop the uncontrolled bleeding which can occur from its use.
b. The study on which Pradaxa was approved is based on lies.
c. the maker of Pradaxa was told not to use direct-to-consumer marketing, but did so anyway.
d. the makers of Pradaxa have been sanctioned by the court four times for discovery violations.
e. Pradaxa makers have claimed their product is 35 percent better than Warfarin, but there may be a fraction of one percent difference in effectiveness.
f. In May 2013 the FDA told Pradaxa’s makers that they could no longer use the bogus 35% for their claims of greater effectiveness.

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