Weitz & Luxenberg is taking cases of eye disorders and vision problems in adults who took pentosan polysulfate sodium (PPS), also known as Elmiron, indicated for relief of bladder pain or discomfort associated with interstitial cystitis, or chronic bladder pain and pressure. The U.S. Food & Drug Administration (FDA) recently added eye disorders related to the drug to its list of Potential Signals of Serious Risks generated by its Adverse Event Reporting System and is currently evaluating the need for regulatory action.
“Interstitial cystitis patients were experiencing bladder pain and discomfort and used Elmiron, which they relied on to be effective and safe,” said Ellen Relkin, Weitz & Luxenberg’s practice group co-chair for defective drugs and medical devices. “But as a result of taking Elmiron, some patients are now, through no fault of their own, suffering from a variety of serious vision problems, ranging from vision impairment to blindness in one or both eyes, which the medical literature suggests likely is irreversible.”
Ocular Risks of Elmiron
Elmiron, which is manufactured by Janssen Pharmaceuticals, was approved by the FDA to treat bladder pain and discomfort associated with interstitial cystitis.
Elmiron has come under scrutiny after studies have linked it to vision problems, described as a type of pigmentary maculopathy, but which sometimes may be diagnosed as macular degeneration or macular or pattern dystrophy. The macula is responsible for central and detailed vision.
A study in JAMA Ophthalmology found that patients with exposure to PPS experienced metamorphopsia, in which straight lines may appear wavy, blurred vision, and prolonged dark adaptation. A similar study published in the Journal of Urology identified the most common symptoms of PPS-related ocular problems as difficulty reading and adapting to dim lighting. Authors of studies discussing these PPS-related eye problems have described PPS-related ocular toxicity as “vision-threatening.”
Elmiron has no warnings regarding eye problems in its labeling and there are now several dozen adverse events related to eye disorders and vision problems similar to those discussed in the medical literature that have been reported in the FDA’s FAERS database.
W&L Can Help Patients Experiencing Vision Problems After Taking Elmiron
Weitz & Luxenberg encourages anyone who has been diagnosed with an eye disorder or vision problems, such as maculopathy, pigmentary maculopathy, retinopathy, degenerative maculopathy/macular degeneration, macular retinopathy, macular/pattern dystrophy, or retinal pigment epithelium atrophy resulting in scotomas, vision loss, vision impairment, halo vision, unilateral or bilateral blindness, or blurred vision after taking Elmiron to contact the firm using the online form on this page or by calling (877) 813-9272 for a free consultation.
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