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Elmiron Lawsuit

Elmiron Lawsuit

Elmiron® is a popular drug for bladder pain that is linked to a progressive eye disease called pigmentary maculopathy.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Elmiron induced injury cases in all 50 states. If you or somebody you know has been diagnosed with vision loss, blindness, or other eye problems, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

UPDATE: Elmiron Label Updated With Retina Pigmentary Changes, Maculopathy

In June 2020, the FDA finally updated the warning label on Elmiron to warn doctors and patients about the risk of severe vision side effects that can lead to blindness, including retinal pigmentary changes and cases of maculopathy.

According to the FDA, “Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.”

What is Elmiron?

Elmiron® is a medication that is used to treat interstitial cystitis, or “painful bladder syndrome. Elmiron has been sold in the U.S. since 1996 and it is now available as a generic medication called pentosan polysulfate sodium or PPS.

Bladder Drug Linked to Blindness

Elmiron has been linked to dozens of reports of people who suffered pigmentary maculopathy, an eye disease that causes irreversible vision loss. It is only known to occur in patients on long-term treatment with Elmiron, typically 10 years or more.

What is the Problem?

Unfortunately, patients and doctors may be unaware of the risk. Eye diseases from Elmiron are commonly misdiagnosed by doctors as age-related macular degeneration, genetic eye diseases, or pattern dystrophy.

Symptoms of Elmiron Eye Problems

The most common symptoms for people suffering Elmiron-related eye damage include:

  • Vision loss
  • Dim vision
  • Trouble seeing things up close
  • Difficulty reading
  • Difficulty adapting eyes to darkness
  • Dark spot near center of vision
  • Straight lines appear curved
  • Colors are less vivid
  • Distorted vision
  • Blindness

Experts: High Doses of Elmiron Pose Significant Risk of Eye Damage

Patients on high doses of Elmiron have a significant risk of retinal toxicity, according to a recent study by researchers at UCLA. Unfortunately, even low-doses of Elmiron are linked to reports of vision loss and blindness.

Vision May Worsen for Years After Stopping Elmiron

Tragically, vision may worsen even after stopping Elmiron. In one case report, a woman who stopped taking Elmiron continued to lose her vision in both eyes for 6 more years, according to Harvard researchers. Click here to read more.

Emory Eye Center Discovers Eye Disease in 6 Women on Elmiron

From 2015 to 2018, doctors at the Emory Eye Center discovered an entirely new eye disease in six female patients. All six women had difficulty reading, adjusting their eyes to the dark, and other vision problems and all of them were taking Elmiron®.

Using advanced retinal imaging, the doctors found that pigment cells in the eye’s retina were literally changing color, resulting in significant vision problems.

They named the new disease pigmentary maculopathy and the study was published by the American Academy of Ophthalmology in November 2018.

Were You Diagnosed With Age-Related Eye Disease?

You may have been misdiagnosed. Older patients on Elmiron might be misdiagnosed with age-related eye diseases by doctors who are not aware of the risk. If they continue taking Elmiron, their eye disease may continue to get worse.

The symptoms of Elmiron-related eye disease are very similar to age-related macular degeneration. In fact, Emory’s doctors warned that patients on Elmiron might be misdiagnosed by a doctor who is not aware of the link between Elmiron and eye damage — resulting in far worse eye damage.

Elmiron Maculopathy is Commonly Misdiagnosed

Elmiron maculopathy is commonly misdiagnosed as the following eye diseases:

  • Age-related macular degeneration
  • Pattern dystrophy
  • Retinal dystrophy
  • Macular dystrophy
  • Genetic disorders or age-related vision loss
  • Stargardt disease
  • Retinal pigmentary endothelium injury

Dozens of Reports of Elmiron Eye Problems

In March 2019, the authors updated the study to report another 32 possible cases of maculopathy linked to Elmiron. They also warned about “a potential severe toxicity.”

Elmiron Vision Loss is Likely Permanent, Experts Warn

The authors also warned that vision loss from Elmiron is likely permanent: “The vision-threatening pigmentary maculopathy identified in this study is irreversible and vision loss of this nature is not recoverable.”

What is Maculopathy?

Maculopathy, also known as macular degeneration, is an eye disease that damages the center of a person’s field of vision. It is a leading cause of progressive vision loss and blindness.

Pigmentary maculopathy specifically involves damage to the macula, which is a part of the retina that collects highly-detailed images in the center of the eye and sends them to the brain.

Drug-Maker Knew in the 1990s that Elmiron Might Cause Serious Eye Injuries

When Emory Eye Center discovered retinal maculopathy in 6 patients on Elmiron, they looked back at clinical trial data of 2,499 patients who took Elmiron in the 1990s. Vision and eye problems were reported in the clinical trials including optic neuritis and retinal hemorrhage but these side effects were never listed on the drug’s warning label. No further research or tests were done.

Will Janssen Pharmaceuticals Recall Elmiron?

When new side effects are linked to a drug that is already on the market, pharmaceutical companies can take certain actions. For example, they can agree to study the side effect, update the drug’s warning label, or voluntarily recall a medication.

Drug-Maker Stays Silent on Elmiron Eye Risks

None of these actions have been taken by Janssen Pharmaceuticals, the company that makes Elmiron®. Many experts agree that Elmiron poses a substantial risk of eye injuries, including permanent blindness, but Janssen Pharmaceuticals has done nothing.

What Should I Do?

There is no excuse for drug-makers who fail to warn patients about severe side effects. If you ever took Elmiron (or currently take it), you need to see an ophthalmologist and start documenting your eye health regularly. Pay particular attention to your retinas.

Get Your Eyes Checked and Track Progressive Retinal Damage

If you take Elmiron or used Elmiron in the past, it is essential that you and your ophthalmologist establish a baseline as soon as possible. This is essential to keep track of any unusual changes, monitor for new eye diseases, or track the progression of eye problems associated with Elmiron.

Joining a Class Action or Filing a Lawsuit

If you have retinal damage after taking Elmiron, this data will help you make a stronger legal case for filing a lawsuit or joining a class action. A growing number of lawyers are concerned that Janssen Pharmaceuticals may have put your health in harm’s way and failed to warn you about the risk.

You May Be Eligible for Compensation

Innocent people become helpless victims when pharmaceutical companies put profits over safety, fail to warn patients about severe side effects, and continue selling dangerous medications.

As a victim of a dangerous drug, you may be eligible to file an Elmiron lawsuit and seek financial compensation through an individual lawsuit, class action lawsuit, or a settlement. This compensation might include “money damages” for your pain and suffering, medical bills, permanent injuries, decreased quality of life, and more.

Do I have an Elmiron Lawsuit?

The Schmidt Firm, PLLC is currently accepting Elmiron induced injury cases in all 50 states. If you or somebody you know has been diagnosed with vision loss, blindness, or other eye problems, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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