Elmiron Class Action Filed Over Future Risk of Pigmentary Maculopathy, Vision Loss For Former Users

A group of plaintiffs have filed a class action lawsuit over Elmiron, alleging the side effects of the interstitial cystitis drug may cause users to develop a form of retina damage and vision loss known as pigmentary maculopathy.

The complaint (PDF) was filed by plaintiffs Jane Appelbaum, Linda Hall, Kenaope Rutang and Dawn Darrow in the U.S. District Court for the Southern District of Florida on October 9, seeking class action status to pursue damages on behalf of all users over of Elmiron.

The lawsuit names Teva Pharmaceuticals, Ivax, LLC, Janssen Pharmaceuticals, its parent company Johnson & Johnson, as well as Alza Corporation and Bayer Healthcare Pharmaceuticals as defendants, asking the court to require the companies to pay for medical monitoring to detect the potential vision side effects of Elmiron that may arise anytime in the future.

Elmiron (pentosan polysulfate sodium or PPS) was introduced in 1996, and is the only approved medication for treatment of interstitial cystitis, which is also commonly referred to as “painful bladder syndrome.”

For decades the drug was sold without any warnings or information that users may experience latent retina damage, leading to permanent vision loss, centralized dark spots, difficulty adjusting in dark light and other complications.

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 recommends baseline retinal examinations when starting treatment and periodically while continuing to take the medication.

Some reports have also suggested vision problems from Elmiron may continue to progress even even after the medication is discontinued, with progressive worsening noted up to 10 years after the medication is no longer used.

“Defendants knew or should have known that Elmiron, when taken as prescribed and intended, causes harmful retinal damage and pigmentary maculopathy,” the lawsuit states. “Nevertheless, Defendants failed to warn, instruct, advise, educate, or otherwise inform Elmiron users, Elmiron prescribers, or United States governmental regulators about the risk of pigmentary maculopathy or the need for medical, ophthalmological monitoring. At all relevant times, the U.S. label for Elmiron made no mention of risk to patients’ eyes or vision.”

The Elmiron class action indicates former users require regular retina examinations and vision monitoring, as early detection of pigmentary maculopathy may be important to alleviate the toxic long-term effects of the drug. Therefore, plaintiffs say the drug make should implement a medical monitoring program for themselves and other Florida residents, to provide for early detection and treatment for the remainder of their lives.

The case also joins a growing number of Elmiron lawsuits filed by former users who state they have already been diagnosed with pigmentary maculopathy or other permanent retina damage following use of the drug, alleging they may have avoided the vision problems if earlier warnings and information had been provided.

Since most ophthalmologists and urologists were unaware of the link between Elmiron and vision problems until recently, many users have continued to take the drug even after developing symptoms, and often were misdiagnosed with other forms of eye disease.

As Elmiron vision loss lawyers continue to review and file claims in the coming months and years, it is expected hundreds of similar complaints will eventually be brought throughout the federal courts system.