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Oct. 15, 2015: Pradaxa Investigation Reveals Fault of FDA, Boehringer Ingelheim

After tireless investigation, the Project On Government Oversight (POGO), a watchdog group, has concluded that the U.S. Food and Drug Administration (FDA) failed in their obligation to properly review Pradaxa, a blood thinning medication, before it hit the market. As a result of this shoddy regulation, the Institute for Safe Medication Practices (ISMP) reported the death of almost 2,000 patients in connection to Pradaxa by late 2012.

Information on Pradaxa

Pradaxa (dabigatran etexilate mesylate) prevents the formation of blood clots and is prescribed to reduce the risk of stroke in patients with non-valvular atrial fibrillation. Pradaxa is manufactured by Boehringer Ingelheim, whose U.S. headquarters are located in Ridgefield, CT.

For more information on your legal rights, visit Pradaxa Lawsuit Help.

PRADAXA BLEEDING AND PRADAXA LAWSUITS

The Law Firm of Eric H. Weinberg is currently investigating cases on behalf of individuals who may have suffered serious or life threatening complications, including internal bleeding, after taking Pradaxa. We have a personal injury lawyer ready to help you. If you or a loved one has experienced a Pradaxa side effect and you have a question regarding your legal rights, please visit our Drug Lawsuits page, or call us 24/7 toll free at 1-877-934-6274 for a free lawsuit evaluation. We promise to bring our more than 20 years of experience litigating pharmaceutical cases to bear in your Pradaxa lawsuit.

POGO Findings on the FDA’s Review of Pradaxa

Furthermore, it has been revealed in the 2014 lawsuits against Boehringer Ingelheim that the drugmaker actively altered or concealed research results in order to make the drug more appealing to the public.

However, this is just a small part of the overall findings of the POGO report.
To see the entire POGO report, visit POGO Dangerous Decision-Making at the FDA.
Other facts questioning the efficacy of the FDA’s regulation process and the ethics of Boehringer Ingelheim include the following points:

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The FDA allowed Pradaxa to enter the market with no antidote to address the risk of hemorrhaging that come with taking the medication. This decision to approve despite the lack of antidote was justified by all the benefits of Pradaxa, which supposedly mitigated that factor. Since that decision, thousands have died of untreatable hemorrhaging brought on by Pradaxa, and the FDA has since repudiated that decision.

• The FDA approved Pradaxa based on deeply biased, unblinded studies conducted by Boehringer Ingelheim. An “unblinded” study means the researchers knew which subjects were taking Pradaxa, and so could adjust their results in order to get desirable conclusions for the drug manufacturer to present to the FDA.

• The FDA allowed Boehringer Ingelheim to market Pradaxa in a manner that the FDA itself referred to as “misleading”.

• Boehringer Ingelheim used doctors that had been previously faulted by the FDA to conduct their clinical trials. Still, the FDA did not “put its foot down”, even when Boehringer Ingelheim’s doctors were found to grossly mismanage their studies, even resulting in the death of several subjects.

• The FDA did not order Boehringer Ingelheim to include a “Black Box” warning on Pradaxa to inform doctors and patients about the hazards of Pradaxa, namely its lack of antidote and risk of hemorrhaging.

• Several members of the FDA review committee that allowed Pradaxa to enter the market had close ties to the pharmaceutical industry; one member even received payments from Boehringer Ingelheim in 2013 totaling more than $21,000, in the form of food and beverage, travel and lodging, and, primarily, consulting. Further more, two members continued on to later become paid employees of Boehringer Ingelheim. These relationships very well could have influenced the review committee to ultimately allow Pradaxa onto the market in exchange for favor from the drug maker.

These are just a few of the many problems found by POGO in their Dangerous Decision-Making at the FDA Report.

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