Bladder Drug Elmiron Linked To “Irreversible Vision Damage,” Lawsuit Claims

According to allegations raised in a recently filed lawsuit over the side effects of Elmiron, the medication used for long-term treatment of “painful bladder syndrome” left an Ohio woman with permanent vision loss and retina damage.

The complaint (PDF) was filed earlier this month by Velma Lehmann in the U.S. District Court for the District of New Jersey, indicating that makers of the bladder drug failed to warn consumers about the toxic vision risks.

The lawsuit indicates Lehmann was prescribed Elmiron in July 2009 and used the medication through May 2020. However, Lehmann indicates she suffered retinal pigmentary changes as a result of the drug’s use. Those changes affected her vision, resulting in “potentially irreversible vision damage” the lawsuit states.

Elmiron (pentosan polysulfate sodium or PPS) was introduced in 1996, as a treatment for interstitial cystitis, which results in bladder and pelvis pain. Although the drug has been used long-term for years by thousands of individuals, the drug makers did not provide any warnings or indication that Elmiron may cause retina damage until earlier this year.

It was only after a series of independent case reports and studies were published about the link between Elmiron and maculopathy that the drug maker announced a warning label update in June 2020, which now advises users, urologists and opthalmologists that the bladder drug has been linked to a form of eye disease known as pigmentary maculopathy, which can cause a range of vision problems, including difficulty adjusting in dark light, trouble reading, centralized dark spots and other complications.

Lehmann’s lawsuit claims defendants knew long before they made the label warning changes that Elmiron side effects could damage users’ vision, but withheld warnings from patients and the medical community.

“Plaintiff Velma Lehmann would not have used Elmiron had Defendants properly disclosed the risks associated with the drug,” the lawsuit states. “Thus, had Defendants properly disclosed the risks associated with Elmiron, Plaintiff Velma Lehmann would have avoided the risk of developing the injuries complained of herein by not ingesting Elmiron.”

The case joins a growing number of Elmiron lawsuits now being pursued throughout the U.S. court system, each involving similar allegations that former users may have avoided permanent retinal damage if earlier warnings and information had been provided.

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.

As Elmiron lawyers continue to review and file claims in the coming months and years, it is expected that hundreds of similar complaints may be brought in state and federal courts nationwide.