Lawsuit Alleges Painful Bladder Drug Elmiron Caused Pigmentary Changes and Irreversible Vision Loss

In a recently filed product liability lawsuit, a California woman indicates the side effects of Elmiron may have permanently worsened her vision, causing her to suffer retinal pigmentary changes.

The complaint (PDF) was filed late last month by Iris Smith in the U.S. District Court for the Eastern District of California, indicating the manufacturers of the interstitial cystitis drug failed to adequately warn users and the medical community about the vision risks.

Smith indicates she began taking Elmiron (pentosan polysulfate sodium or PPS) in 2000, and continued to take the treatment for years to address her bladder pain. However, after she began treatment, Smith indicates Elmiron caused pigmentary changes in her retina, which could leave her with permanent vision loss.

“The development of Plaintiff Iris Smith’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize safety signals, suppression of information revealing serious risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Elmiron,” the lawsuit states. “This conduct, as well as the product defects complained of herein, was a substantial factor in bringing about and exacerbating Plaintiff’s injuries.”

Although Elmiron has been on the market for decades, no warnings were provided about the toxic effect the painful bladder drug may have on the retina until earlier this year, leaving many doctors unaware the medication may be the cause of blindness and vision problems experienced by long-term users.

It was only after a series of independent case reports and studies were published about the link between Elmiron and pigmentary maculopathy that the drug maker announced a warning label update in June 2020, which now advises users, urologists and opthalmologists that Elmiron may cause retinal pigmentary changes, resulting in vision problems like difficulty adjusting in dark light, trouble reading, centralized dark spots and complete blindness.

Since most ophthalmologists were previously unaware of the vision risks associated with Elmiron, many users were misdiagnosed with other forms of retinal disease and continued to be exposed to the medication, further worsening the damage.

Smith’s claim joins a growing number of Elmiron lawsuits now being pursued throughout the U.S. court system. However, as lawyers continue to review and file claims in the coming months and years, it is expected that hundreds, if not thousands, of similar complaints may be brought in state and federal courts nationwide.