Elmiron Lawsuit

Urinary medication, Elmiron (pentosan polysulfate) has been linked to pigmentary maculopathy, a degenerative ocular disorder which may result in vision loss or blindness. People who used Elmiron for urinary and pelvic pain caused by interstitial cystitis may be filing Elmiron lawsuits to seek compensation for eye damage or vision loss.

free case evaluation
Quick Summary
Elmiron Vision Loss Lawsuit

Researchers have linked long-term use of urinary drug, Elmiron (pentosan polysulfate) to a degenerative eye disorder known as pigmentary maculopathy which can result in vision loss or blindness. Up to 25% of people who use Elmiron for longer than 6 months may develop eye damage due to drug toxicity.  Some Elmiron users may be considering filing an Elmiron Vision Loss Lawsuit against the drug’s manufacturer, Janssen Pharmaceuticals and its parent company, Johnson & Johnson.

Elmiron and Macular Disorder

Elmiron is used to treat urinary pain associated with interstitial cystitis, a rare condition which affects mainly women. People who experience relief from Elmiron, will generally be on the medication for a long period of time, potentially for life-time treatment.

Researchers have found that an average of 25% of people taking Elmiron for longer than 6 months may experience ocular degeneration due to drug toxicity. The specific condition has been identified as pigmentary retinal maculopathy which affects the macula at the back of the eye. Macular damage may lead to visual disturbance, vision loss or eventual blindness. The longer Elmiron is taken, the greater the amount of ocular damage may occur.

Elmiron Vision Loss Lawsuit

Elmiron vision loss lawsuit

Researchers have found that up to 25% of people who use Elmiron (pentosan polysulfate sodium) for long-term treatment of urinary pain associated with interstitial cystitis, may develop eye damage from a condition known as pigmentary retinal maculopathy.

Damage to the macula, a part of the eye in front of the retina, appears to be due to drug toxicity and longer use of the medication may produce more damage. Many of the patients identified in a 2019 study presented at the meeting of the American Academy of Ophthalmology had initially been diagnosed with another macular or degenerative eye disorder like pattern dystrophy.

Elmiron’s manufacturer, Janssen Pharmaceuticals and its parent company, Johnson & Johnson may be facing a number of Elmiron lawsuits filed by people who have experienced vision loss, eye damage or blindness.

What is Elmiron?

Elmiron (pentosan polysulfate sodium) was approved in 1985 for the treatment of urinary pain related to interstitial cystitis. It is manufactured by Janssen Pharmaceuticals, a division of the healthcare giant, Johnson & Johnson

Elmiron was originally granted “orphan drug” status as it was the only available treatment for a rare disorder. Though Elmiron is still the only medication that is approved to treat interstitial cystitis, it no longer requires orphan drug status to protect market exclusivity.

Elmiron is available as a 100mg capsule, to be taken three times daily on an empty stomach and though it is classified as a low-molecular weight heparin-like drug with anticoagulant properties, the exact mechanism of action or way that it works for interstitial cystitis is not well understood. The medication may take 3 or more months to begin working and if unsuccessful, the drug will be discontinued after 6 months.

People who experience relief from Elmiron, will generally be on the medication for a long period of time, potentially for life-time treatment. Researchers have found that an average of 25% of people taking Elmiron for longer than 6 months may experience ocular degeneration due to drug toxicity. The specific condition has been identified as pigmentary retinal maculopathy which affects the macula at the back of the eye. Macular damage may lead to visual disturbance, vision loss or eventual blindness. The longer Elmiron is taken, the greater the amount of ocular damage may occur.

What is Interstitial Cystitis?

Interstitial cystitis (IC) is a chronic bladder disorder which causes urinary or pelvic pain. Though it was once considered a rare disorder, it is part of a group of diseases that has become more prevalent. Other conditions such as “bladder pain syndrome” (BPS) and “overactive bladder” (OAB) may have similar symptoms but are generally thought to be caused by different mechanisms and includes cellular changes in the tissue surrounding the bladded.

Interstitial cystitis may more than 1 million people in the U.S., most of whom are women. Symptoms of IC include recurring episodes of discomfort, pressure, or pain in the pelvic region and bladder. This may be accompanied by the need to urinate frequently or urgently, in some cases, multiple times per hour throughout the day. About half of all IC patients are unable to maintain full-time employment due to bladder issues.

For most people with interstitial cystitis, symptoms begin slowly and worsen over time. Symptoms may change from day to day and may worsen suddenly or be triggered by other medical issues such as irritable bowel syndrome or endometriosis. Though no direct link has been found, interstitial cystitis may be more common in people who also have other conditions such as severe allergies, irritable bowel syndrome, migraine headaches, chronic fatigue syndrome and fibromyalgia.

Elmiron Vision Disorder

Several ophthalmologists, in 2018, identified a trend of Elmiron users who had developed macular disorders or other vision problems. They conducted a review of interstitial cystitis patients using Elmiron through Northern California’s Kaiser Permanente and found that about 25% of long-term Elmiron users had developed vision problems or been diagnosed with a macular disorder. The data for the review was presented at the 2019 fall meeting of the American Academy of Ophthalmology.

The researchers found that of 140 patients initially identified who had taken Elmiron for more than 6 months, 91 were willing to submit to additional study. Further examinations including retinal imaging and other diagnostic procedures found that 22 of the 91, or about 1 in 4 patients had developed significant drug toxicity involving the vision, specifically relating to pigmentary maculopathy.

Some of these patients were already known to have eye damage but had been diagnosed with other conditions such as macular degeneration or pattern dystrophy. The additional exams showed that their conditions were likely caused by Elmiron toxicity which caused degeneration of the macula, led to visual disturbance or vision loss, and may eventually result in blindness. In addition, the longer exposure to the medication resulted in greater damage to the eye and vision.

Symptoms of maculopathy disorder in Elmiron patients include:

  • Difficulty reading
  • Blurry Vison
  • Loss of close vision
  • Night blindness
  • Dark spots
  • Visual dimming
  • Blindness

Lack of FDA Warnings for Elmiron Eye Damage

Though the connection between macular damage and Elmiron was identified in 2018 and studied the following year, no warnings have been added to prescribing information for Elmiron. Current labelling does not include any warnings for visual disturbance, macular damage, night blindness or any other eye conditions.

It appears that longer use of Elmiron may be associated with worsening damage for people who experience this drug toxicity. Experts recommend that Elmiron users should be screened annually for retinal damage and vision loss with a potential need for imaging scans and consultation with a retina specialist, particularly if any vision loss is noted.

Though macular damage is generally considered to be permanent, progression of the disease may be limited if medication is stopped during the early stages of the pigmentary maculopathy disorder.

Elmiron Vision Loss Lawsuits

Some people who have taken Elmiron for urinary pain associated with interstitial cystitis and developed vision problems, macular damage or blindness, may be considering filing Elmiron Vision Loss Lawsuits to seek compensation for their injuries. If successful, drug injury lawsuits may provide compensation for medical costs, lost wages, pain and suffering, disability and other damages. Those who took Elmiron for more than 6 months for urinary pain due to interstitial cystitis and who developed vision loss, eye problems or were diagnosed with a macular disorder such as pigmentary maculopathy may be eligible for compensation and should seek legal assistance.

Have you been affected by a drug or device listed?