Elmiron Lawsuits Filed Because Drug Company Failed to Warn Before June 2020 About Elmiron-related Vision Loss Side Effects
(Posted by Tom Lamb at Drug Injury Watch)
We are handling Elmiron lawsuits for patients who have developed Elmiron-associated retinopathy, retinal pigmentary changes, or pigmentary maculopathy due to their past use of Elmiron. These Elmiron lawsuits are filed against the drug companies responsible for Elmiron. This is because — despite a growing number of Elmiron-related vision loss case reports in the medical literature over the years — it was not until June 2020 that any warning about these eye problem side effects was included in the Elmiron drug label here in the US.
Both before and after that Elmiron label change in June 2020, there have been various medical studies about the association between Elmiron and serious eye problems such as retinal pigmentary changes or pigmentary maculopathy. We have written several earlier Drug Injury Watch posts, starting back in 2020, covering some of the medical journal articles reporting on those Elmiron side effects studies.
In this post, we draw your attention to the latest such Elmiron study report article, "Pentosan Polysulfate Sodium-Associated Pigmentary Retinopathy: Risk Factors and Fundus Findings", which was published just days ago (December 24, 2021) by the Clinical Ophthalmology medical journal.
From the Abstract we get a summary of this December 2021 medical journal article about Elmiron:
- Purpose: To evaluate the risk factors and fundus findings of patients with potential [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy.
- Patients and Methods: A retrospective chart review was performed of patients exposed to [Pentosan Polysulfate Sodium / Elmiron] who had a dilated fundus examination at a large retina-only practice from 2018– 21. Multimodal images were evaluated by masked reviewers.
- Results: A total of 148 patients were included, of whom 33 (22%) had [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy, and 115 (78%) did not. The mean age was 60.3 years old, and the mean follow-up was 11.8 months. The [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy group had higher mean cumulative doses of [Pentosan Polysulfate Sodium / Elmiron] (1600g± 849 vs 864g± 852, P < 0.0001, Mann–Whitney test) and longer duration of [Pentosan Polysulfate Sodium / Elmiron] use (13.6 years vs 7.48, P < 0.0001). There was no statistically significant difference based on a history of kidney or liver disease or the dosage per day for the weight, body mass index, body surface area, or lean body weight. Of the patients with [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy whose genetic results were available, 15 of 16 (93%) were heterozygous for variants of uncertain significance.
- Conclusion: A longer duration of [Pentosan Polysulfate Sodium / Elmiron] use and higher cumulative dosage of [Pentosan Polysulfate Sodium / Elmiron] were associated with an increased risk of developing [Pentosan Polysulfate Sodium / Elmiron]-associated pigmentary retinopathy. The role of genetic mutations in patients exposed to [Pentosan Polysulfate Sodium / Elmiron] is still to be determined.
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For some important details about Elmiron-associated retinopathy, we point out this excerpt from the Discussion part of that Clinical Ophthalmology medical journal
Some patients with [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy may unfortunately experience difficulty with dark adaptation, reading, contrast sensitivity, and changes in mesopic microperimetry. In the current study, the [Pentosan Polysulfate Sodium / Elmiron]-associated retinopathy group was more likely to have complaints of difficulty with their visual field, reading, dark adaptation, and visual acuity....
There is currently no treatment for [Pentosan Polysulfate Sodium / Elmiron]-associated maculopathy, and the retinopathy can progress even after discontinuing [Pentosan Polysulfate Sodium / Elmiron]. In a multicenter study of 11 patients who had discontinued [Pentosan Polysulfate Sodium / Elmiron], 77% continued to experience progression, with the RPE atrophy growing at a rate of 0.32mm per year, and 9% developing worsening vision over 12 months.... [footnotes omitted]
We are currently investigating possible Elmiron lawsuits for patients diagnosed with Elmiron-associated retinopathy as well as these other serious Elmiron side effects:
- Maculopathy (retinal or pigmentation)
- Retinal Pigmentary Endothelium Injury (RPE)
- Pigmentation Maculitis
- Macular Degeneration (pigmentation or dry)
- Vision Loss / Blindness
It is important to know that our Elmiron lawsuits for patients who have suffered any of these Elmiron side effects are filed only against the pharmaceutical companies responsible for Elmiron — not the doctors who prescribed the Elmiron as a treatment for their bladder diseases.
Significantly, it is not necessary for the patient to have been using Elmiron regularly right up until the time when their Elmiron-related vision loss was diagnosed in order to file an Elmiron lawsuit. That is, unlike most other drug injury cases, the patient could have stopped using Elmiron months before a medical doctor was able to diagnose their eye problem.
For possible Elmiron lawsuits, we encourage you to submit an Elmiron Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb.
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