Elmiron Vision Problems Came After More Than 20 Years of Use: Lawsuit

According to a recently filed product liability lawsuit, a lack of adequate warnings and transparency provided by drug makers about Elmiron vision problems has left an Ohio woman with permanent retina damage after using the interstitial cystitis drug for more than two decades.

The complaint (PDF) filed by Tammy Hopkins in the U.S. District Court for the Southern District of Ohio on August 28, indicating that Teva Pharmaceuticals, Johnson & Johnson, and it’s Janssen and Ortho-McNeil subsidiaries have failed to warn consumers and the medical community about the risk that long-term users may develop pigmentary maculopathy, which may continue to worsen even after the drug is discontinued.

Hopkins says she began taking Elmiron in 1996, after being diagnosed with the painful bladder condition interstitial cystitis. She continued to use the drug until earlier this year, indicating she was unaware of the link between Elmiron and problems with her vision that have surfaced in recent years.

In about 2017, the lawsuit notes Hopkins began experiencing a myriad of vision complications, including difficulty seeing at night, delayed adaption to light, eye pain, floaters and distorted vision. In July 2020, she was diagnosed with a type of retina damage from Elmiron known as pigmentary maculopathy, The lawsuit notes the injury could have been avoided or minimized if earlier information had been provided by the drug makers.

Elmiron (pentosan polysulfate sodium or PPS) has been marketed as safe and effective since 1996, without any indication the drug may cause latent retinal damage or impaired vision until the drug makers updated the warning label in June 2020, indicating users may be at risk of developing a form of eye disease known as pigmentary maculopathy

The new warnings of Elmiron vision problems were only added after a series of independent studies and case reports were published, which highlighted cases where long-term users Elmiron experienced a range of vision problems, including in difficulty adjusting in dark light, problems reading, centralized dark spots and other complications.

“Notwithstanding Defendants’ duty to ensure that the warning label for Elmiron sold in the United States was adequate, and even though Defendants had a continuing responsibility to conduct post-marketing surveillance and to study the safety and efficacy of Elmiron, Defendants did nothing to ensure that the Elmiron label in the United States included a warning similar to the one introduced in Europe, or a warning of any type for that matter,” Hopkins’ lawsuit states. “It was not until June 16, 2020 that Defendants revised the Elmiron label in the United States to include a warning of ‘Retinal Pigmentary Changes.’ Prior to that date, Defendants did not warn, and made no effort to warn, healthcare professionals or patients in the United States of the risk of harm, including, but not limited to, pigmentary maculopathy associated with long-term Elmiron use.”

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.