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Study Reveals Link Between Elmiron Exposure and Maculopathy


Elmiron (pentosan polysulfate sodium or PPS) is used to treat interstitial cystitis, a bladder condition that affects women more than men. Use of Elmiron has been linked to maculopathy, an eye condition that can lead to vision loss. In 2020, doctors at Northwestern University’s Department of Ophthalmology looked at the medical records of 131 patients who had taken Elmiron.

The cohort study, which is titled Maculopathy Secondary to Pentosan Polysulfate Use, involved an examination of patients’ medical records between January 1, 2002 and January 1, 2019. Of the 131 patients whose medical records were reviewed, a total of 40 patients underwent imaging. The remaining 91 patients underwent a fundus examination, which allows an ophthalmologist to see the retina of the eye.

Of the 40 patients who underwent imagine, a total of 5 patients (12.5%) had characteristics suggestive of Elmiron-induced maculopathy. Of the remaining 91 patients who underwent a fundus examination, 5 patients (5.4%) exhibited macular pigmentary changes.

As such, a total of 10 patients from the group of 131 patients were suspected to be suffering from maculopathy that developed after taking Elmiron. The 10 affected patients had been taking Elmiron for an average of 4.2 years, which is considered long-term usage.

Elmiron Receives Enhanced Warning Concerning Maculopathy

In June of 2020, Janssen Pharmaceuticals Inc., the manufacturer of Elmiron, added a new warning to the drug’s label identifying pigmentary maculopathy as a potential consequence of using Elmiron long-term.

The enhanced warning states that most cases of maculopathy developed in patients who took Elmiron for more than three years but notes that some patients who developed maculopathy took Elmiron for less than three years. The visual symptoms listed in the new warning that some patients have experienced include the following:

  • Difficulty reading;
  • Slow adjustment to low or reduced light environments; and
  • Blurred vision.

The new Elmiron warning notes that the “visual consequences” of the above-listed “pigmentary changes are not fully characterized.” The warning admits that the reason for the development of maculopathy in some patients who took Elmiron long-term is unknown but notes that the duration and frequency of use are driving factors.

As more patients become aware of the link between Elmiron and the development of maculopathy, more lawsuits will likely follow. To what extent Janssen Pharmaceuticals was aware of the risk of maculopathy and subsequent vision loss is unclear. The expansive Elmiron litigation will eventually uncover what the drug manufacturer knew, and whether there was a failure to communicate known warnings to medical providers and patients.

Speak to an Elmiron Lawyer Today

Have you suffered maculopathy or another eye condition after taking Elmiron? If so, speaking with an Elmiron lawyer is a good first step to finding out whether you may be entitled to compensation for your injuries. Because there are time limits on the amount of time you have to file a lawsuit, it is best to act quickly.

Each Elmiron lawyer at Searcy Denney represents clients injured by defective and dangerous drugs like Elmiron. Our seasoned trial lawyers strive to provide clients with the best chance possible of receiving compensation for their suffering. To receive a free case evaluation, contact our office today by calling (800) 780-8607 or by completing a case inquiry form on our website.

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