New Medical Article Describes How to Identify, Image, and Diagnose Pigmentary Maculopathy Caused by Elmiron Use
On December 15, 2020 a Dear Healthcare Professional Letter titled, "ELMIRON (pentosan polysulfate sodium) and the Risk of Pigmentary Maculopathy", was issued in Canada by Janssen, Inc. and Health Canada. Its key messages were: (1) Cases of Elmiron pigmentary maculopathy have been reported with long-term use of Elmiron; and, (2) Elmirion is now contraindicated in patients with a previous history of any macular pathology.
As background, pigmentary maculopathy is an eye disease that changes the center of the retina (also called the "macula"). In turn, pigmentary maculopathy may harm the patient’s vision and may lead to a permanent decrease or loss of central vision.
From the December 2020 Elmiron "Dear Doctor" letter we get the following details:
Cases of pigmentary maculopathy have been reported with long-term use of ELMIRON. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision.
This recent Elmiron "Dear Doctor" letter sent out in Canada also provides some guidance to patients who have used Elmiron:
Patients should report to their healthcare professional any changes in their vision such as difficulty reading, slow adjustment to low or reduced light, blurred vision, blurry or wavy vision near or in the centre of their field of vision.
For more about the symptoms of pigmentary maculopathy as well as how doctors might diagnose this serious eye disease which may lead to significant vision loss, we refer you to a December 22, 2020 medical article, "From Bladder Pain to Blurry Vision: Pentosan Polysulfate Sodium and the Development of a Novel Maculopathy", published in Ophthalmic Surgery, Lasers and Imaging Retina.
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From that article we get the following medical information about Elmiron pigmentary maculopathy:
Symptoms most commonly reported were blurred vision, prolonged dark adaptation, and metamorphopsia. The most common presenting diagnoses for these cases were macular or pattern dystrophy and age-related macular degeneration. [Visual acuity (VA)] correlated with degree of foveal atrophy, and in some cases, cystoid macular edema (CME) or choroidal neovascularization. There is one case of CME that was responsive to anti-vascular endothelial growth factor (VEGF) therapy.
Clinical features of [Elmiron (pentosan polysulfate sodium)] maculopathy are quite distinct from other macular dystrophies or toxicity. These include 1) bilateral symmetric pathology centered on and frequently involving the fovea, 2) macular hyperpigmented spots, yellow-orange deposits, and/or patchy RPE atrophy, with 3) densely packed hyper- and hypoautofluorescent spots on FAF, and 4) focal [retinal pigment epithelium (RPE)] thickening on [optical coherence tomography (OCT)] with hyperreflectance on [near-infrared reflectance (NIR)] imaging. In particular, a peripapillary hypoautofluorescent halo can be useful in distinguishing [Elmiron (pentosan polysulfate sodium)] maculopathy from [age-related macular degeneration (ARMD)] and hereditary dystrophies that are usually peripapillary-sparing.... [Footnotes omitted.]
This December 2020 medical journal article contains a couple of alerting statements:
- The prevalence of maculopathy in patients taking [Elmiron (pentosan polysulfate sodium)] is estimated to be 20% to 25%. In a cohort of 219 patients with [interstitial cystitis (IC)], patients with [Elmiron (pentosan polysulfate sodium)] exposure had an odds ratio (OR) of 11.25 for developing an unspecified pigmentary maculopathy, and all 14 patients with definite clinical characteristics of [Elmiron (pentosan polysulfate sodium)] maculopathy had exposure to [Elmiron (pentosan polysulfate sodium)]. [Footnotes omitted.]
- In aggregate, these findings are potentially alarming and possibly represent a major patient safety issue. Many patients with PPS exposure may have been previously misdiagnosed with age-related macular degeneration or retinal dystrophies, which may have led to preventable, irreversible vision loss or misguided genetic counseling.
Our law firm is investigating possible Elmiron lawsuits for patients who have suffered vision loss due to Elmiron pigmentary maculopathy. If we can be of assistance to you or someone else regarding an Elmiron vision loss case, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.
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