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Elmiron Vision Loss Lawsuit

This case is no longer active

The Legal Team

Kimberly Barone Baden

Fred Thompson III

View Other Attorneys

Medical Drug Attorneys

Case Overview

Elmiron®, also known as pentosan polysulfate sodium (PPS), is a treatment for bladder pain and inflammation. It’s the only FDA-approved oral medication available to treat the chronic bladder condition interstitial cystitis (IC). People taking Elmiron, for relief from the pain and discomfort caused by IC, have reported experiencing unexpected complications, including a newly discovered, progressive eye disease that may result in permanent vision loss.

July 8, 2020

UPDATED LABEL WARNS OF PERMANENT VISION LOSS

Janssen Pharmaceuticals updated Elmiron’s label in June 2020 to warn of potential damage to the retina and irreversible vision loss that Elmiron could cause. According to the new label, the majority of damage and vision loss were reported in patients who had been taking Elmiron for at least three years, but cases involving patients who took Elmiron for a shorter time were also reported. Read more.

Elmiron (PPS) side effects

The Emory Eye Center in Atlanta released a study in November 2018 in which it found “a novel and possibly avoidable maculopathy associated with chronic exposure to PPS.” This newly discovered eye disease is often misdiagnosed as retinal pigmentary maculopathy, pattern dystrophy, or age-related macular degeneration.

The American Academy of Ophthalmology found similar results in a study it performed on patients at Kaiser Permanente in Northern California. Roughly a quarter of patients who reported significant use of Elmiron showed signs of eye damage, the study found.

Common signs of Elmiron®-associated eye damage/vision complications may include:

Difficulty adapting to changes in light
Blurred vision (often centrally in the patient's field of vision)
Dark spots in center of vision, blind spots or floaters
Straight lines appearing curved or squiggly
Muted, less vivid colors
Changes in the color of the eye

If you or a loved one took Elmiron and have been diagnosed with one of the following you may have a legal claim:

Retinal Maculopathy
Retinal Pigmentary Endothelium Injury (RPE)
Pigmentary Maculopathy
Pigmentation Maculopathy
Pigmentation Macular Degeneration
Dry Macular Degeneration

Elmiron background

Interstitial cystitis mostly affects women and causes chronic pain in the bladder and pelvis. The FDA approved Elmiron in 1996 to treat IC. It is the only FDA-approved oral medication to treat the condition, which is believed to affect millions of Americans.

Previously manufactured by Baker Norton Pharmaceuticals, the drug is currently owned and manufactured by Janssen Pharmaceuticals, Inc., a Johnson & Johnson subsidiary.

The drug’s label did not warn of potential permanent vision loss or eye damage until the update to the drug’s label was made in June 2020.

Our medical drug litigation experience

Motley Rice medical attorneys have experience litigating for patients alleging they were hurt by dangerous prescription and over-the-counter drugs, including representing clients in large scale litigation against Janssen Pharmaceuticals and Johnson & Johnson. Our attorneys also hold multiple leadership positions in litigation related to defective medical devices or potentially harmful prescription medications.

We understand that as a patient or family member, what you know about your or a loved one’s medications may be limited. If you believe a medicine made you sick or hurt you, our attorneys have the resources needed to thoroughly investigate and:

Identify potentially harmful medicines,
Review if the medicine hurt you,
Review the medicine manufacturer’s compliance with FDA regulations,
Examine the adequacy of the manufacturer's warning to you about potential side effects
Recognize other issues that could affect your potential claim.

Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death.