Elmiron Lawsuit

The side effects of the interstitial cystitis drug Elmiron have been linked to form of vision loss and retina damage known as pigmentary maculopathy.

ELMIRON VISION LOSS LAWSUITS: Product liability lawyers are reviewing potential Elmiron lawsuits for long-term users who have experienced eye problems or vision side effects, which may have been diagnosed as age-related macular degeneration or other retinal disease.

MANUFACTURER: Janssen Pharmaceuticals, Inc.

OVERVIEW: Elmiron (pentosan polysulfate sodium, or PPS) was approved by the FDA in 1996 for the treatment of interstitial cystitis, which affects more than 1 million people in the U.S. alone. Also known as “painful bladder syndrome”, interstitial cystitis involves to severe and chronic pain in the bladder and groin. Although the drug has been on the market for decades, increasing evidence published in recent years has found that Elmiron may have a toxic impact on the retina, leading to irreversible vision loss.

This maculopathy from side effects Elmiron may result in:

  • Vision loss
  • Loss of vision detail
  • Loss of night vision
  • Difficulty reading
  • Inability to drive

ELMIRON MACULOPATHY: A number of studies and case reports published in recent years have highlighted the potential link between Elmiron and pigmentary maculopathy, leading many experts to now describe the retinal disease as “Elmiron maculopathy” or “PPS maculopathy”, referring the active pharmaceutical ingredient in the drug.

In May 2018, researchers with the Emory Eye Center in Georgia first raised concerns about this risk in a retrospective case report published in the medical journal Ophthalmology, which suggested long-term Elmiron use could cause this atypical maculopathy that results in deterioration of areas of the retina that control highly detailed vision.

These eye problems appear to worsen the longer Elmiron is used, and vision may continue to degrade even after the medication is stopped according to a study published in February 2020. This appears to have been confirmed by another study on persisting Elmiron vision problems published in July 2020.

Following additional research, Elmiron warnings were updated in Canada to add information about the risk of pigmentary maculopathy in September 2019, but the same information was not provided to U.S. consumers or doctors.

As a result of the drug makers decision to withhold information about this risk for decades, many ophthalmologists and doctors remain unaware of the risk As a result, these Elmiron vision problems are often misdiagnosed as other conditions, such as age-related macular degeneration, pattern dystrophy or other retinal diseases.

LAWSUITS OVER ELMIRON VISION LOSS: Product liability lawyers are evaluating whether users may be entitled to compensation through an Elmiron lawsuit as result of the decision by the drug makers to withhold warnings for decades about the importance of carefully monitoring users for signs of vision loss or other side effects associated with pigmentary maculopathy, which may get progressively worse the longer the drug is used.

Request a free consultation and claim evaluation to determine whether you, a friend, or a family member may be entitled to financial compensation or an Elmiron vision loss settlement.

Elmiron Lawsuit Alleges Latent Retinal Damage And Impaired Vision Caused By Bladder Drug

According to allegations raised in a recently filed product liability lawsuit, a California woman suffered permanent retinal damage from Elmiron, claiming the makers of the bladder drug failed to warn consumers and the medical community about toxic side effects the medication may have on vision.

The complaint (PDF) was filed by Shirley Ruth Levy in the U.S. District Court for the District of New Jersey on August 12, indicating she was left with vision loss following four years of using Elmiron for treatment of interstitial cystitis or “painful bladder syndrome.”

The lawsuit names Azla Corporation, Johnson & Johnson, several of its subsidiaries, including Janssen Pharmaceuticals, Bayer Healthcare, and Teva Pharmaceuticals as defendants, indicating that the drug makers knew or should have known about the link between Elmiron and retinal damage for years, yet withheld warnings and information until a label update was issued in June 2020.

Elmiron (pentosan polysulfate sodium or PPS) has been marketed as safe and effective since 1996, without any indication provided until recently about the toxic effects on the retina, which may result in a condition known as pigmentary maculopathy.

Prior to the warning label update in June 2020, a series of independent studies and case reports have been published in recent years that described users of Elmiron who experienced damage to the retina, resulting in difficulty adjusting in dark light, problems reading, centralized dark spots and other complications. However, prior information was not provided to users or the medical community about the importance of monitoring for vision problems while using the medication.

“At all relevant times, Defendants have failed to adequately warn or instruct patients, the medical community, or prescribers in the United States that Elmiron causes, is linked to, and is associated with vision threatening retinal changes, including vision loss,” the lawsuit states. “Defendants failed to mention vision-threatening retinal changes or the need for opththalmological monitoring in any of the patient materials – including the Patient Education Flyer and Patient Brochure – the sources of information most likely viewed by physician and patients.”

Levy indicates she began taking Elmiron in 2013, and continued to use the medication through at least 2017. As a result of the exposure, she claims that she has suffered toxic maculopathy, retinal damage, blurred vision, distorted vision and other vision problems.

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.