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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
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
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
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
- 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
- A study released earlier this year has shown that the retinal
damage associated with Elmiron is distinguishable from hereditary
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
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, and health professionals are advised to
obtain a detailed ophthalmologic history in all patients prior to
starting treatment with the drug. The Monograph now also
acknowledges 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
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
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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