Ward Black Law 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.
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.
Ward Black Law 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. Complete the form to the right for a free case evaluation. You can also call or text us at (800)531-9191 or by email at email@example.com.