Medical Studies Find Elmiron “significantly increased odds of having atypical maculopathy” Such as Pigmentary Maculopathy


(Posted by Tom Lamb at


Elmiron (pentosan polysulfate sodium) was approved by the FDA in 1996 for the treatment of interstitial cystitis (“IC”), also known as “bladder pain syndrome” or “painful bladder syndrome.”. In recent years, however, there have been reports of current as well as past Elmiron users developing vision loss due to Elmiron-related maculopathy. But you would not have had any warnings about these vision problems in the Elmiron Prescribing Information document, or package insert, until June 2020, when the FDA mandated an Elmiron label change.

In more detail, maculopathy — a degeneration of the central part of the retina — can result in a range of symptoms, including:

• Central vision loss
• Blurred, dimmed, or spotty vision
• Difficulty reading
• Difficulty adjusting to low light or changes in lighting
• Pain in the eye

Despite a growing number of Elmiron-related maculopathy case reports in the medical literature over the past few years, it was not until earlier this summer that the Elmiron package insert, or drug label, finally included some warnings about vision problems. Specifically, on June 16, 2020, the FDA Elmiron label change. The label was updated to include retinal pigmentary changes, otherwise known as pigmentary maculopathy, to the “Warnings and Precautions” as well as the “Adverse Reactions” sections of the label.

On June 16, 2020, there was finally an Elmiron label change which added cautions about retinal pigmentary changes, otherwise known as pigmentary maculopathy, to the “Warnings and Precautions” as well as the “Adverse Reactions” sections of the Elmiron drug label. Remarkably, prior to that time, despite reports of Elmiron-related maculopathy, the Prescribing Information for Elmiron in the US simply stated “Warnings: None”.

Due to this alleged overdue Elmiron label change which added warnings concerning vision problems such as retinal pigmentary changes and pigmentary maculopathy, there have been drug injury product liability lawsuits filed against pharmaceutical companies responsible for Elmiron over the years. The Defendants named in a typical lawsuit filed on behalf of an Elmiron user who developed vision problems might be some combination of the following:

  1. JANSSEN PHARMACEUTICALS, INC., f/k/a Ortho-McNeil-Janssen Pharmaceuticals, Inc., f/k/a Janssen Pharmaceutica Inc.
  2. JOHNSON & JOHNSON d/b/a Alza Corporation, d/b/a Janssen Ortho LLC, d/b/a Janssen Research & Development LLC, d/b/a Ortho-McNeil Pharmaceuticals, Inc.
  3. BAYER HEALTHCARE PHARMACEUTICALS, INC. f/k/a Bayer Pharmaceuticals Corporation
  5. BAYER U.S. L.L.C.

Further, these Elmiron drug injury lawsuits usually contain these types of legal claims alleged against those pharmaceutical companies: Strict Liability / Negligence / Misrepresentation / Breach of Warranty.

As for the medical evidence pointed to in these Elmiron lawsuits, one study, “Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium [Elmiron],” focused on six women who used Elmiron for treatment of their interstitial cystitis and later presented to the Emory Eye Center between May 2015 and October 2017 with pigmentary maculopathy.

Thereafter, a medical journal article, “Association of Macular Disease with Long-Term Use of Pentosan Polysulfate Sodium: Findings from a U.S. Cohort“, was published by the British Journal of Ophthalmology in November 2019 which stated that “PPS [Elmiron] users had significantly increased odds of having atypical maculopathy . . . .”

We are currently investigating possible Elmiron drug injury lawsuits for patients diagnosed with a vision-related Elmiron side effect such as:

  • wither pigmentation maculopathy;
  • pigmentation macular degeneration;
  • pigmentation maculitis;
  • retinal maculopathy; or,
  • dry macular degeneration.

Significantly, the patient does not need to be taking Elmiron up until the time of their Elmiron side effect diagnosis, unlike most drug injury cases. Medical & Legal Information About Drug Side Effects
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