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Elmiron-Induced Macular Toxicity

  • Author:John Ray
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Elmiron-Induced Macular Toxicity

Elmiron-Induced Macular Toxicity

This litigation is past the emerging phase, however, there are still clients in need of representation. We are going to cover this drug and the ongoing litigation.

For firms not familiar with pharmaceutical litigation that may still wonder “how do these harmful drugs get FDA approval”, this one will educate as well as possibly leave you in shock.

First: Elmiron (pentosan polysulfate sodium) is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects, but the mechanism of action of pentosan polysulfate sodium in interstitial cystitis

 

How an Apparently Worthless Drug Gets Approved

The innovator of this drug failed to get approval, eventually the drug ended up on the “trash heap” however, that does not deter “big pharma”. The attitude of the industry seems to be “we have a drug, we are going to find something for the drug to treat”.

The original application for approval was submitted to the FDA in 1991 which was deemed non-approvable in 1993. A second non-approvable letter was sent in 1994 over concerns about the lack of data on efficacy of the drug. Elmiron was granted an Orphan Drug designation in 1995 (the trash heap).

Finally:  Elmiron (pentosyn polysulfate sodium) was approved in 1996 to be used as a treatment for interstitial cystitis and painful bladder symptoms. However, the maker still could not show “ how the drug worked” –“,” but the mechanism of action of pentosan polysulfate sodium in interstitial cystitis is not known”.

Pain is generally considered subjective therefore, a clinical trial for a drug that is intended to relieve pain simply needs to show that a certain percentage of trial participants believed they had less pain after taking the drug.

As Fate Would Have It

So, an apparently worthless drug was approved to treat a subjective condition, the maker can’t explain how the drug treats the condition and it may make you go blind.

Are you shocked yet? Join us for the June Mass Tort Success Course, you may be shocked by many things you discover and learn but more importantly, you will also discover why your help is needed to protect consumers against dangerous products. It’s not like the FDA is having much success.

https://www.aboutlawsuits.com/wp-content/uploads/2020-5-4-elmiron-english-complaint.pdf

 



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