In June 2020, Janssen Pharmaceuticals changed the label for Elmiron, warning users that the drug could cause vision problems. Unfortunately, this warning came too late for at least one patient.

A Kansas woman, Rebecca Gassman, started experiencing vision problems in 2019. She had been taking Elmiron to treat her painful bladder condition and interstitial cystitis (IC). The following year, Gassman received a diagnosis for permanent retinal injury and vision loss connected with her use of the drug. In May 2020, she filed a lawsuit against Janssen Pharmaceuticals Inc. and Johnson & Johnson. The lawsuit was filed in the United States District Court for the Eastern District of Pennsylvania.

The Complaint

The complaint alleges that the Defendants’ drug is dangerously defective and that they designed, marketed, and distributed it, fully aware of its risks, but never disclosed those risks to the public, the Plaintiff’s doctor, the medical community, or the Food and Drug Administration (FDA).

The defects to which the complaint alludes include Elmiron’s serious link to significant visual damage, including pigmentary maculopathy. Tens of thousands of patients were put at risk of this condition, due to the Defendants’ negligence, the complaint states.

Studies Connecting Elmiron to Vision Problems

Elmiron (pentosan polysulfate sodium or PPS) is the only drug that has been FDA-approved for IC and painful bladder symptoms. It is unknown how the drug works to relieve symptoms of these conditions.

A study published by Ophthalmologyjournal in 2018 concluded that chronic exposure to PPS associated with a “novel and possibly avoidable maculopathy.” In its analysis of six adult patients who took Elmiron, patients experienced trouble reading and prolonged adaptation to darkness. Researchers’ conducted multimodal imaging and functional studies and found likely retinal pigment epithelium (RPE) injury.

Ultimately, the drug has been linked to pigmentary maculopathy, which causes the retina’s macula (central portion) to develop excessive capillaries that impact central vision.

In October 2019, American Academy of Ophthalmology News published another study conducted by three ophthalmologists. Their review of patients at Kaiser Permanente revealed that around 25 percent of those who had endured significant exposure to Elmiron “showed definite signs of eye damage.” More alarming, the condition of medication toxicity could be confused with age-related macular degeneration and other retinal conditions.

Widespread Exposure

Because more than one million U.S. patients suffer from IC and bladder/pelvic pain, and Elmiron is the only approved treatment, it is estimated that hundreds of thousands of patients have probably been exposed to the drug—and to its effects, according to Review of Ophthalmology.

Patients who have taken Elmiron for years might consider getting an annual screen for retina damage. Those who are now suffering vision problems may be able to file a lawsuit against Janssen Pharmaceuticals and parent company Johnson & Johnson to recover damages.

Sara Stephens is a freelance writer who has developed a hefty portfolio of work across several industries, with a strong emphasis on law, technology, and marketing. Her work has appeared in the New York Times, as well as various technology and consumer publications, both print and online. Sara also works as a freelance book editor, having developed and edited manuscripts for bestselling and novice authors alike, and as a verbal strategist for a Miami branding consultancy.