New Study Links Long-Term Elmiron Use to Increased Risk of Vision Loss

A new study published in the scientific journal Retina suggests long-term exposure to Elmiron – pentosan polysulfate sodium (PPS) – may increase a person’s risk of vision loss and other vision problems.

Elmiron, a drug that treats pain associated with interstitial cystitis (IC), has been the target of numerous lawsuits filed by victims who claim the medication caused them vision problems – including pigmentary maculopathy, a condition that affects the part of the eye (macula) responsible for central vision.

The latest study published in Retina adds to growing scientific literature establishing a link between Elmiron and retinal eye damage, and provides more evidence for plaintiffs filing suit against Elmiron manufacturer Janssen Pharmaceuticals.

About the Study

As part of the study, researchers distributed surveys to individuals diagnosed with interstitial cystitis (IC), a bladder condition characterized by recurring pelvic pain, discomfort in the bladder and pelvic region, and urinary frequency and urgency.

An estimated 4 to 12 million Americans may have IC, and Elmiron (PPS) is the only oral prescription medication approved by the FDA to treat IC and associated bladder and pelvic pain.

Here are some of the study’s findings:

• The survey was completed by 912 respondents, 96.4% of whom were female, with a median age of 55.
• Among respondents who used Elmiron (PPS), the median exposure was 547.5 grams.
• Survey respondents with the highest levels of PPS exposure were more likely to report vision problems (including difficulty reading small print) and have a diagnosis of pigmentary maculopathy and/or macular degeneration than those who did not use Elmiron.

New Research Adds to Growing Scientific Literature

The Retina study is only one of many in a long list of research that shows a link between Elmiron – and particularly long-term use – and vision loss/vision problems.

Other notable studies include:

• An Emory Eye Center study (2018) found patients taking Elmiron for 15 years developed unusual changes in the part of the retina responsible for clear central vision (macula). Researchers behind the study warned long-term Elmiron use may cause retinal damage.
• Research presented at the American Academy of Ophthalmology (AAO) Annual Meeting (2019) revealed links between Elmiron and vision-threatening eye conditions. According to the study, 25% of patients with significant Elmiron exposure (taking Elmiron for six months or more) showed clear signs of eye damage, a figure that may actually be higher as Elmiron-related eye damage may be misdiagnosed as macular degeneration or pattern dystrophy.
• A study published in The British Journal of Ophthalmology (2019) found PPS patients had significantly increased odds of having a new diagnosis of macular disease / pigmentary maculopathy after 7 years of taking Elmiron.
• A study from ophthalmologists at Kaiser Permanente (2020) noted Elmiron toxicity may increase with the amount of medication taken, from 11% for patients who take between 500 to 1,000 grams to 42% for patients taking 1,500 grams or more.

Despite years of research suggesting links between PPS and vision problems, Janssen Pharmaceuticals did not update Elmiron’s product labeling to warn about vision problems until June 2020.

The label now states Elmiron can cause retinal pigmentary changes, blurred vision, reading problems, and sensitivity to low light, and recommends patients taking Elmiron regularly have their vision tested.

Elmiron Litigation Gains Steam

In light of the growing scientific evidence behind PPS and vision problems, thousands of patients diagnosed with pigmentary maculopathy, vision loss, and other vision problems after taking Elmiron have started to file lawsuits against Janssen Pharmaceuticals.

These suits claim Janssen failed to ensure the safety of its medication and seek damages for permanent vision loss, pain and suffering, lost income, and medical bills – including expenses associated with increased medical monitoring.

On December 15, 2020, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered all Elmiron lawsuits to be consolidated in the District of New Jersey. MDL consolidation allows related federal lawsuits to be grouped together under one judge, and can help increase efficiency in the lawsuit process.

Discuss Your Rights & Legal Options with an Elmiron Injury Attorney

Bailey Cowan Heckaman PLLC has been closely tracking research into Elmiron’s risks and ongoing litigation against Janssen Pharmaceuticals.

As an award-winning trial practice recognized for our work representing plaintiffs in complex cases involving product liability and dangerous drugs, we are available to victims and families who would like to learn more about Elmiron lawsuits and their legal options.

To speak personally with an attorney from BCH, call us or contact us online. Consultations are free and confidential, and available to victims nationwide.