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Study shows half of patients consuming pentosan polysulfate sodium unaware of drug’s harmful effects

Elmiron, a drug containing the active ingredient pentosan polysulfate sodium (PPS), is a medication that may be prescribed to treat interstitial cystitis, a condition characterized by chronic bladder or pelvic pain or discomfort.

Studies have demonstrated a link between this medication and a progressive retinal disease known as pigmentary maculopathy. Symptoms of pigmentary maculopathy may include blurred vision (decreased visual acuity), seeing straight lined as warped or wavy (metamorphopsia), difficulty reading, slow adjustment to low or reduced light (prolonged dark adaptation), and visual disturbances near the centre of the field of vision (central field defects or central scotoma).

Elmiron induced pigmentary maculopathy is a novel diagnosis associated with chronic usage of the drug. It’s important for users of PPS and their treating healthcare providers to be aware of the potential harms associated with PPS ingestion. It is also important to ensure that PPS maculopathy is not confused with other retinal conditions. In 2019, Health Canada released a medical alert, advising that cases of pigmentary maculopathy had occurred with chronic use of Elmiron. The Elmiron Canada Product Monograph was later revised in October 2020. Health Canada then posted a letter to healthcare professionals advising of the risk of PM linked to PPS in December 2020.

Pentosan polysulfate sodium usage and knowledge of pigmentary maculopathy in Alberta

In May 2024, researchers published a study which investigated knowledge of pigmentary maculopathy amongst users of PPS in Alberta. Of the users surveyed, only half reported awareness of the potential harms of PPS on the retina and visual acuity prior to being invited to participate in the survey, despite 86% of the participants reporting to have visited an optometrist or ophthalmologist in the year prior.

Amongst the surveyed users who were aware of the risk of pigmentary maculopathy associated with PPS, only 9% had been advised of the risk by their prescribing physician. More commonly, the patients aware of the association had been informed through media, including online, television, and radio.

Challenges with pigmentary maculopathy diagnosis

In a 2022 study, researchers described that pigmentary maculopathy may be confused with or misdiagnosed as age-related macular degeneration due to the similarities in age of onset and symptomatology. Similarly, PPS-associated pigmentary maculopathy may be confused with some inherited retinal dystrophies. Mukhopadhyay et al highlighted the importance of screening all new ophthalmology patients taking PPS and in any patients with a diagnosis of age-related macular degeneration for potential misdiagnosis.

Siskinds can help

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 recours@siskindsdesmeules.com.

Explore our previous video blog post for an overview of the Elmiron (pentosan polysulfate) Class Action Litigation pursued by Siskinds LLP and our Quebec affiliate office, Siskinds Desmeules.

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