Medical Studies Find Elmiron "significantly increased odds of having atypical maculopathy" Such as Pigmentary Maculopathy
(Posted by Tom Lamb at DrugInjuryWatch.com)
Elmiron (pentosan polysulfate sodium / "PPS") 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 patients who used Elmiron developing vision loss due to Elmiron-related maculopathy. But there were not any warnings about these Elmiron eye problems in the Elmiron Prescribing Information document, or drug label, until June 2020, when the FDA mandated an Elmiron label change. This situation has resulted in Elmiron lawsuits filed by patients who have vision loss due to Elmiron.
It is important for patients who used Elmiron to know that maculopathy -- a degeneration of the central part of the retina, which permanently impairs vision -- can have 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 some warnings about vision problems were added to the Elmiron drug label here in the US. Specifically, on June 16, 2020, there was 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".
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This Elmiron label change which finally added warnings concerning vision problems such as retinal pigmentary changes and pigmentary maculopathy was overdue from our perspective. Accordingly, there have been Elmiron lawsuits filed by patients who have suffered vision loss against the pharmaceutical companies responsible for Elmiron.
The Defendants named in a typical Elmiron drug injury product liability lawsuit might be some combination of the following:
- JANSSEN PHARMACEUTICALS, INC., f/k/a Ortho-McNeil-Janssen Pharmaceuticals, Inc., f/k/a Janssen Pharmaceutica Inc.
- 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.
- BAYER HEALTHCARE PHARMACEUTICALS, INC. f/k/a Bayer Pharmaceuticals Corporation
- BAYER CORPORATION
- BAYER U.S. L.L.C.
Further, Elmiron lawsuits filed by patients 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 [Elmiron]: 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
- dry macular degeneration
Significantly, a person does not need to be using Elmiron up until the time when their Elmiron-related eye problem was diagnosed in order to be in a position to file an Elmiron lawsuit (unlike most other drug injury cases). Please feel free to contact us if we can be of assistance as regards a possible Elmiron lawsuit.
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