Lawsuit Information Center
Our lawyers are handling Elmiron macular eye injury lawsuits in all 50 states alleging that victims’ macular degeneration was caused by the use of the drug for interstitial cystitis.
Elmiron is the brand name for pentosan polysulfate sodium, a prescription drug that is used by millions to treat a bladder condition called interstitial cystitis (IC).
In 2018, however, medical researchers discovered that prolonged use of Elmiron can cause some users to develop a new eye disease called pigmentary maculopathy which can result in vision impairment and blindness. Pigmentary maculopathy is only known to be caused by long-term use of pentosan polysulfate sodium.
As a result, many victims have filed an Elmiron lawsuit alleging this side effects of this IC drug caused their macular eye injury.
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Elmiron and Interstitial Cystitis
Interstitial cystitis (IC) is a chronic health condition involving the bladder that causes pelvic pain and discomfort and urinary frequency. IC is also known as painful bladder syndrome. The bladder is a muscle that communicates with the brain through pelvic nerves. These nerves are how the bladder gives you the urge to urinate when it’s full.
In people with IC, the signals from the bladder through the pelvic nerves become distorted. The primary symptom of this is having to urinate much more frequently than normal. IC can also cause acute pain in the pelvic region.
IC is a very common medical condition. It is estimated that around 12 million people in the U.S. suffer from IC. IC tends to occur more frequently in women than in men. Around 75% of all IC cases are diagnosed in women.
Elmiron (pentosan polysulfate sodium) is the only FDA-approved drug for the treatment of IC. Elmiron was developed by Janssen Pharmaceuticals and first released in 1996. Since then, millions of patients have been prescribed Elmiron for the treatment of their IC. Most Elmiron patients used the medication daily for long periods.
Pentosan polysulfate sodium is a synthetic polysaccharide that forms a protective coating that binds to the urothelium. This coating helps protect the bladder tissue from some of the harsh components of urine that are related to IC and its symptoms. The standard dosage regimen for Elmiron is 100 gm three times daily.
Link Between Elmiron and Eye Damage
Since it was first approved in 1996, Elmiron was assumed to be safe with very few risks or potential side effects.
In 2018, however, Dr. Nieraj Jain, an ophthalmologist at the Emory Eye Center in Atlanta, Georgia began noticing a strange condition in several patients. Dr. Jain had 6 patients who were all displaying a very unique type of macular eye damage none of his colleagues had encountered before. The condition had some similarities to age-related macular degeneration. But it was not identical.
To determine possible causes of this condition, Dr. Jain and others at Emory undertook an in-depth review of the medical histories of all 6 patients with the unique condition. It did not take very long for them to identify one obvious commonality among the 6 patients. All of them suffered from IC and had been taking Elmiron for many years.
The group at Emory determined that the long-term use of Elmiron was causing this novel type of macular eye damage. Their findings were published in the November 2018 issue of Ophthalmology. The announcement of this discovery led to a series of follow-up studies. The most comprehensive of which was conducted by a team of ophthalmologists in California based on data from Kaiser Permanente patients.
This research team identified 91 patients in the San Francisco area who had taken Elmiron on a long-term basis (an average of 5000 pills over 15 years) and were willing to participate by having an eye exam. Out of this group of 91 participants, eye examinations showed that 22 of them had clear evidence of the unique macular eye disease first identified at Emory. The results of this study were presented at the American Academy of Ophthalmology conference in October 2019.
The unique eye condition first discovered at Emory and believed to be linked to long-term Elmiron use was eventually given an official name by the medical community: pigmentary maculopathy (also referred to as PPS maculopathy).
Why Does Long-Term Elmiron Use Cause Eye Damage?
The evidence connecting the long-term use of Elmiron to pigmentary maculopathy is very strong and widely accepted in the medical community. Pigmentary maculopathy is a unique disease that is ONLY known to be associated with prolonged use of Elmiron. No cases of pigmentary maculopathy have been diagnosed in someone who is not a long-term Elmiron user.
Although the connection between Elmiron and pigmentary maculopathy is clear, it is not entirely understood how or why long-term use of pentosan polysulfate sodium triggers the disease. Pentosan polysulfate causes a wide range of biological responses which are not fully understood.
One theory is that pentosan polysulfate disrupts RPE-photoreceptor homeostasis. Another suggestion is that pentosan polysulfate inhibits fibroblast growth factors which are known to be important to retinal health.
Elmiron Eye Damage Lawsuits
The scientific evidence showing that long term use Elmiron can cause a unique type of eye damage called pigmentary maculopathy has prompted hundreds of Elmiron eye damage lawsuits. The lawsuits allege that Janssen knew or should have known that prolonged Elmiron use could cause eye damage and failed to warn doctors or patients about that risk.
As of May 2022, around 900 former Elmiron users have filed eye damage lawsuits against Janssen Pharmaceuticals. The Elmiron lawsuits in federal courts have been consolidated into a class-action MDL in the District of New Jersey (In re: Elmiron (Pentosan Polysulfate Sodium) Prod. Liab. Lit. – MDL No. 2973). Judge Brian Martinotti has been assigned to oversee the MDL.
The progress in the Elmiron MDL has been frustratingly slow. The opening bellwether test trials are supposed to begin in January 2023, but it looks like that time frame will get pushed back because the initial pool of bellwether candidate cases has not even been finalized yet.
FAQs: Elmiron Eye Damage Lawsuits
Does Elmiron cause eye damage?
Medicial researchers recently discovered that prolonged use of the prescription drug Elmiron can lead to the development of a unique type of macular eye damage resulting in vision impairment and blindness.
What type of eye damage does Elmiron cause?
Prolonged Elmiron use has been linked to unique type of macular eye damage called pigmentary maculopathy
How does it take for Elmiron to cause eye damage?
Studies have shown that regular use Elmiron could lead to macular eye damage in just 3 years.
What percentage of Elmiron users will get eye damage?
Studies have found that around 25% of participants who used Elmiron for 10 years or longer displayed signs of macular eye damage.
Does Elmiron cause macular degeration?
Research has shown that long-term use of Elmiron causes a unique type of eye damage that is similar to macular degeration. The condition associated with Elimron is called pigmentary maculopathy and it is often misdiagnosed as age-related macular degeration.
File an Elmiron Eye Damage Lawsuit
If you have been diagnosed with pigmentary maculopathy after years of using Elmiron, you may be eligible to file an Elmiron eye damage lawsuit and seek financial compensation. Call an Elmiron lawyer today at 800-553-8082.