According to allegations raised in a recently filed product liability lawsuit, a California woman suffered permanent retinal damage from Elmiron, claiming the makers of the bladder drug failed to warn consumers and the medical community about toxic side effects the medication may have on vision.

The complaint (PDF) was filed by Shirley Ruth Levy in the U.S. District Court for the District of New Jersey on August 12, indicating she was left with vision loss following four years of using Elmiron for treatment of interstitial cystitis or “painful bladder syndrome.”

The lawsuit names Azla Corporation, Johnson & Johnson, several of its subsidiaries, including Janssen Pharmaceuticals, Bayer Healthcare, and Teva Pharmaceuticals as defendants, indicating that the drug makers knew or should have known about the link between Elmiron and retinal damage for years, yet withheld warnings and information until a label update was issued in June 2020.

Elmiron (pentosan polysulfate sodium or PPS) has been marketed as safe and effective since 1996, without any indication provided until recently about the toxic effects on the retina, which may result in a condition known as pigmentary maculopathy.

Prior to the warning label update in June 2020, a series of independent studies and case reports have been published in recent years that described users of Elmiron who experienced damage to the retina, resulting in difficulty adjusting in dark light, problems reading, centralized dark spots and other complications. However, prior information was not provided to users or the medical community about the importance of monitoring for vision problems while using the medication.

“At all relevant times, Defendants have failed to adequately warn or instruct patients, the medical community, or prescribers in the United States that Elmiron causes, is linked to, and is associated with vision threatening retinal changes, including vision loss,” the lawsuit states. “Defendants failed to mention vision-threatening retinal changes or the need for opththalmological monitoring in any of the patient materials – including the Patient Education Flyer and Patient Brochure – the sources of information most likely viewed by physician and patients.”

Levy indicates she began taking Elmiron in 2013, and continued to use the medication through at least 2017. As a result of the exposure, she claims that she has suffered toxic maculopathy, retinal damage, blurred vision, distorted vision and other vision problems.

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.