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Elmiron, a drug to treat a bladder condition affecting hundreds of thousands of Canadians, has been reported to cause vision loss in long-term users.

Elmiron is an oral medication approved to treat interstitial cystitis (also known as painful bladder syndrome). Scientific studies link long-term use of Elmiron to vision issues, including a novel and progressive eye disorder affecting the central part of the retina.

Siskinds is pursuing claims on behalf of Canadians suffering vision loss resulting from their use of prescription Elmiron.

Elmiron is an oral drug prescribed for interstitial cystitis

Interstitial cystitis (“IC”) is a chronic condition that causes bladder pressure, bladder pain, and pelvic pain. The pain associated with IC is often constant, causing a feeling of needing to urinate all day and all night. IC affects hundreds of thousands of Canadians, mostly women.

Elmiron (pentosan polysulfate or PPS) has been marketed in Canada to treat IC since the early 1990s. Upwards of tens of thousands of Canadians may have been prescribed the drug. Elmiron is often used long-term to manage IC. The median duration of use of the drug for long-term users was 15 years in two different scientific studies.1

Studies have linked Elmiron use to vision loss

Scientific studies link use of Elmiron to vision loss, including an eye disorder affecting the part of the retina which allows for highly sensitive, accurate vision. Notable findings include:

  • One study found that about a quarter of people taking Elmiron for five years or more had experienced significant damage to the retina;2
  • Another study identified that more significant exposure to the drug was associated with more severe atrophy;3
  • Yet another has shown that a patient’s condition continued to worsen years after stopping use of the drug;4 and
  • A study released earlier this year has shown that the retinal damage associated with Elmiron is distinguishable from hereditary damage.5

The reported eye problems from Elmiron are significant and vary from blurry vision, to difficulty reading, to having difficulty adjusting and seeing in different lighting conditions.

Elmiron users may initially not attribute their vision issues to Elmiron usage, as the vision loss may be misdiagnosed as attributable to other causes.

Updated label warns of vision issues

In September 2019, Janssen, Inc. (a subsidiary of Johnson & Johnson) revised the Health Canada Product Monograph for Elmiron, which is intended to provide information about the properties, claims, indications and conditions of use of the drug. For the first time, warning information was added regarding vision issues, specifically advising patients to get regular eye exams and to discontinue the drug if vision problems develop.

In the fall of 2019, Health Canada issued a medical alert for Elmiron, warning of the risk of the retina disorder that may develop in patients from long-term Elmiron use.

On May 18, 2020, CTV News broadcast a story warning of the alleged side effects of Elmiron and highlighting the issues raised by the scientific research regarding Elmiron vision loss issues.

In October 2020, further revisions were made to the Elmiron Health Canada Product Monograph. The Monograph changes include:

  • A contraindication for Elmiron in patients with a personal history of any macular pathology;
  • an advisory for health professionals to obtain a detailed ophthalmologic history in all patients prior to starting treatment with the drug; and
  • acknowledgements that cases of pigmentary maculopathy have been seen after less than 3 years of use, that cumulative dose appears to be a risk factor, and that pigmentary maculopathy may lead to a permanent loss of central vision.

Siskinds is pursuing justice for Elmiron users who have been harmed

Siskinds is seeking to recover compensation for Canadians suffering vision loss resulting from their use of prescription Elmiron to treat chronic bladder issues. Siskinds LLP has filed a class action alleging that the makers of Elmiron failed to adequately warn users of Elmiron, and their health care providers, that the use of Elmiron increases the risk of vision loss. Siskinds’ Québec-based affiliate, Siskinds Desmeules, also filed a similar action on behalf of Québec residents.

If you or someone you know has used Elmiron and has suffered vision issues, Siskinds may be able to help. Contact us for more information or to receive a free consultation. Visit www.siskinds.com/elmiron and complete the form at the bottom of the page or call 1-800-461-6166. Quebec residents should contact Siskinds Desmeules by phone at 418-694-2009 or by email at [email protected].

1 Pearce, et al, Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium, Ophthalmology. 2018 Nov;125(11):1793-1802. doi: 10.1016/j.ophtha.2018.04.026; Hanif et al, Strength of Association between Pentosan Polysulfate and a Novel Maculopathy, JAMA Ophthalmol. 2019 Sep 5;137(11):1275-1282. doi: 10.1001/jamaophthalmol.2019.3392.

2 Vora, et al, Prevalence of Maculopathy Associated with Long-Term Pentosan Polysulfate Therapy, Ophthalmology. 2020 Jun;127(6):835-836. doi: 10.1016/j.ophtha.2020.01.017.

3 Wang et al, Pentosan-associated maculopathy: prevalence, screening guidelines, and spectrum of findings based on prospective multimodal analysis, Can J Ophthalmol, 2020 Apr;55(2):116-125. doi: 10.1016/j.jcjo.2019.12.001.

4 Huckfeldt et al, Progressive Maculopathy After Discontinuation of Pentosan Polysulfate Sodium, Ophthalmic Surg Lasers Imaging Retina. 2019 Oct;50(10):656‐659. doi: 10.3928/23258160-20191009-10.

5 Barnes et al, Pentosan polysulfate maculopathy versus inherited macular dystrophies: comparative assessment with multimodal imaging, Ophthalmol Retina. 2020;S2468-6530(20)30200-1. doi: 10.1016/j.oret.2020.05.008.

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