Updated Label to Include Retinal Pigmentary Changes
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Elmiron (pentosan polysulfate sodium) was approved by the FDA on September 26, 1996, for the treatment of painful bladder syndrome (interstitial cystitis). More recently, however, Elmiron has been linked to cases of eye damage and vision-related injuries.
In my previous June 8, 2020, article, "Elmiron Potentially Linked to Severe Eye Disorders", I addressed the Elmiron label, which at the time still stated "Warnings: None". Since the publication of this article, the FDA has released information on a label change for Elmiron, so that retinal pigmentary changes will be added to the label as a potential adverse reaction.
Recent FDA Label Change
On June 16, 2020, the FDA released information regarding an Elmiron label change. The label was updated to include retinal pigmentary changes, otherwise known as pigmentary maculopathy, to the "Warnings and Precautions" as well as the "Adverse Reactions" sections of the label. The symptoms of this adverse reaction were cited to include difficulty reading, slow adjustment to low or reduced light environments and blurred vision. An announcement from the FDA released on June 16, 2020, on the matter states:
Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). 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.
The FDA also now recommends that patients receive retinal examinations including optical coherence tomography (OCT) and auto-fluorescence imaging within six months of starting Elmiron, and then periodically while continuing long-term treatment.
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Leading Up to The Label Change
A 2018 study published by the National Library of Medicine showed a link between Elmiron (pentosan polysulfate sodium or PPS) and pigmentary maculopathy:
We describe a novel and possibly avoidable maculopathy associated with chronic exposure to PPS. Patients reported symptoms of difficulty reading and prolonged dark adaptation despite generally intact visual acuity and subtle funduscopic findings. Multimodal imaging and functional studies are suggestive of a primary RPE injury. Additional investigation is warranted to explore causality further.
Similarly, a follow-up July 2019 study published by the Review of Ophthalmology showed findings of Elmiron related maculopathy:
We recently identified a unique pigmentary maculopathy in a cohort of patients who were receiving chronic pentosan polysulfate sodium therapy (Elmiron, Janssen Pharmaceuticals, Titusville, New Jersey), a popular medication for interstitial cystitis. Upon presentation to our clinic, these patients carried tentative diagnoses, including age-related macular degeneration and pattern dystrophy.
The findings of these studies, and other studies like them may be what led the FDA to requiring an Elmiron label change. Janssen Pharmaceuticals had made
Our law firm is currently investigating cases involving a vision-related Elmiron side effect as a possible drug injury lawsuit against the responsible pharmaceutical companies.
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